ATTACHMENT
Details of the Therapeutic Goods Legislation Amendment (2017 Measures No.1) Regulations 2017
Section 1 - Name
This section provides for the Regulations to be referred to as the Therapeutic Goods Legislation Amendment (2017 Measures No.1) Regulations 2017.
Section 2 - Commencement
This section provides for Part 1 of Schedule 1, and for Schedules 2 - 9, of the Regulations, to commence on 1 July 2017, and for Part 2 of Schedule 1 of the Regulations to commence on 1 January 2018.
Section 3 - Authority
This section provides that the Regulations are made under the Therapeutic Goods Act 1989 (the Act).
Section 4 - Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Regulations has effect according to its terms.
Schedule 1 Variation of entries in the Register
These amendments relate to recommendations 13 and 42 of the Expert Panel Review of Medicines and Medical Devices Regulation (the Review) that Australia adopt a risk-based approach to variations to medicines, by allowing variations to an existing entry in the Australian Register of Therapeutic Goods (the Register) for a medicine that do not impact a medicine's quality, safety or efficacy to be made by notification to the TGA rather than (as currently) requiring the Secretary's pre-approval (Schedule 1 of the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017 (the Amendment Act)). Under subsection 9D(2C) of the Act (added by the Amendment Act), if a sponsor of a registered or listed good in the Register requests the Secretary to vary the entry in the Register for those goods and the variation is of a kind specified in regulations made for the purposes of that provision, and the variation meets the conditions in the regulations for that kind of variation, the Secretary is obliged to vary the entry accordingly.
The kinds of variations listed for this purpose in this Schedule are low risk, straightforward changes to product details which do not impact on the safety of a product and would be subject to certain conditions designed to ensure that there would be no impact on safety associated with such variations.
Part 1 - Registered complementary medicines and registered OTC medicines
Therapeutic Goods Regulations 1990
Item 1 - New regulation 10AAA - Variation of entries in Register - registered complementary medicines and registered over the counter medicines
Item 1 amends the Principal Regulations to specify kinds of variations for which the Secretary must vary the entry in the Register on request by the person in relation to whom the goods are registered for registered over the counter (OTC) medicines, and registered complementary medicines. Item 1 also prescribes conditions for such variations by reference to Version 1.0 of the TGA document 'Notifications process-requests to vary registered medicines where quality, safety and efficacy are not affected' as in force at the commencement of Part 1 of Schedule 1 (a copy of this document is available without charge from the TGA's website, www.tga.gov.au).
The kinds of variations able to be notified to the TGA for registered OTC medicines and registered complementary medicines under new regulation 10AAA are minor, low-risk changes that would not impact on product safety, quality or efficacy - for example:
* a variation to reflect a change to a medicine's label or package insert to highlight that a product is "new" or a "value pack", on the condition, principally, that no other aspect of the medicine's label is to be changed;
* if the name of a medicine's sponsor is not part of the name of the medicine itself, a variation to reflect a change to the sponsor's details (for example, name, logo) as set out on the medicine label or package insert, on the condition, principally, that no other aspect of the medicine's label is to be changed; or
* a variation to a reflect that a medicine will no longer be supplied with an accompanying refill pack, on the condition, principally, that no other aspect of the medicine’s label, or related product information or consumer medicine information, is to be affected.
Item 2 - Clause 3 of Schedule 9 (table item 2A, column 2)
Table item 2A of the table in Part 2 of Schedule 9 to the Principal Regulations sets out fees for requests to vary an entry in the Register for certain medicines and therapeutic devices, and for medical devices.
This item makes a minor amendment to item 2A to make it clear that the fees in that item do not apply to requests to vary an entry in the Register made under new subsection 9D(2C) of the Act (i.e. notifiable variations) - this reflects that the applicable fees for such variations are to be set out in new items in that table (to be introduced by item 3 below).
Item 3 - Clause 3 of Schedule 9 (after table item 2CA)
This item amends the table in Part 2 of Schedule 9 to the Principal Regulations to introduce the following fee structure for requests under subsection 9D(2C) of the Act, in respect of registered OTC medicines and registered complementary medicines:
* for requests to make the same variation or variations to two or more entries in the Register that each relate to a registered complementary medicine, or that each relate to a registered OTC medicine - a single fee of $780 for each group of up to 7 entries (for example, if a sponsor had 11 such entries, they would pay $780 (in respect of the first 7 entries) + $780 (in respect of the remaining 4 entries) = $1560) (this would be new table items 2CC and 2CD, respectively); and
* for requests involving these medicines to amend only one entry in the Register, the applicable fee would be $780 (this would be new table item 2CB).
The fees in this item have been developed based on the cost of the anticipated staff effort and the use and maintenance of IT systems associated with the processing of variations, for these kinds of medicines.
Part 2 - Prescription medicines
Therapeutic Goods Regulations 1990
Item 4 - Regulation 2
This item introduces a definition of a 'biological medicine' for the purposes in particular of new regulation 10AAC, which would set out notifiable variations for such goods.
Under the new definition, a 'biological medicine' is principally defined as a medicine (other than an antibiotic) that is:
* either a vaccine, a peptide or a protein, or is polysaccharide-based;
* derived from humans, animals or other organisms, or produced through recombinant technology or biotechnology; and
* of a kind specified in item 1 of Part 1 of Schedule 10 to the Principal Regulations (this refers to therapeutic goods that contain a substance mentioned in Schedule 4 (Prescription Only), 8 (Controlled Drug) or 9 (Prohibited Substance) to the Poisons Standard, or that contain a substance not mentioned in those Schedules but which would meet the criteria for inclusion in any of those Schedules).
Under this definition, a medicine will also be a 'biological medicine' if it is a human blood product of a kind mentioned in Appendix A of the current Poisons Standard, e.g. whole blood, or albumin.
Item 5:
New regulation 10AAB - Variation of entries in the Register - prescription medicines other than biological medicines
The kinds of variations able to be notified to the TGA for prescription medicines other than biological medicines (the latter also being prescription medicines, for which new regulation 10AAC would make exclusive provision for in terms of prescribing notifiable variations for those products) under new regulation 10AAB are minor, low-risk changes that would not impact on product safety, quality or efficacy - for example:
* a variation to reflect a change to the container or closure system for a medicine's active pharmaceutical ingredient (an example of such a closure system is where such an ingredient is stored in powder form in a polyethylene bag, enclosed in a second polyethylene bag, tied with a strip seal and placed in a sealed drum), on the conditions, principally, that the material of the container or closure system remains unchanged or is upgraded to a more protective material, and that the thickness of that material is not reduced;
* a variation to record that a manufacturing site is no longer being used to manufacture a medicine's active pharmaceutical ingredient, on the condition that there is still at least one other site for that manufacture; or
* a variation to reflect a change to the quantity of a medicine's (non-sterile) active pharmaceutical ingredient that is to be manufactured, on the condition, principally, that there is no change to the route of synthesis and that the change is not due to unexpected events occurring during the manufacturing process or to concerns relating to the stability of the ingredient.
New regulation 10AAC - Specified kinds of variations and condition - biological medicines
The kinds of variations able to be notified to the TGA under new regulation 10AAC for biological medicines are minor, low risk changes that would not impact on product safety, quality or efficacy - for example:
* a variation to reflect a change to the equipment used for quality control testing of the medicine (examples of such equipment can include incubation chambers for microbiological testing and mass spectrometers for chemical testing), on the condition that such changes meet any applicable test method validity criteria;
* a variation to reflect a change to the manufacturer used by the sponsor to manufacture a filter used during the fermentation process for the medicine, on the condition in particular that the new filter meets the same acceptance criteria as the previous such filter; or
* a variation to reflect a change to introduce more stringent internal controls on a fermentation process for the medicine, on the condition that this would not result in any change to the quality characteristics of the product.
Items 6 and 7 - Clause 3 of Schedule 9 (table item 2CB, and after table item 2CD)
Item 6 makes a minor, editorial amendment to table item 2CB in the table in Part 2 of Schedule 9 to the Principal Regulations) (to be introduced by item 3 above, with effect from 1 July 2017), to reflect the change made by item 7.
Item 7 amends the table in Part 2 of Schedule 9 to the Principal Regulations to introduce the following fees for requests under subsection 9D(2C) of the Act, in respect of the variations outlined above, for prescription medicines and biological medicines):
* for requests to make the same variation or variations to two or more entries in the Register involving prescription medicines and biological medicines), where two or more of those medicines have the same active ingredient - a single fee of $780 for each group of entries relating to such medicines with the same active ingredient, and a fee of $780 for each other entry (if any) (this would be new table item 2CE);
* for requests involving these medicines to amend only one entry in the Register, the applicable fee would be $780 (this would be effected through an amendment to table item 2CB).
These fees have been developed based on the cost of the anticipated staff effort and the use and maintenance of IT systems associated with the processing of variations for these kinds of medicines.
Schedule 2 - Exemptions
These amendments relate to recommendation 24 of the Review to allow health practitioners to supply certain unapproved therapeutic goods to their patients under a new notification scheme (Schedule 3 of the Amendment Act). There will not be the need (as currently) to apply to the Secretary for approval to do so. The goods, the health practitioners and the patients subject to the notification scheme will, in accordance with Schedule 3 of the Amendment Act, be specified by rules made by the Minister by legislative instrument. The amendments will, for the purposes of the amendments made to the Act by Schedule 3 of the Amendment Act, restrict the Secretary from authorising the supply of medicines containing certain higher risk substances, and list the kinds of information of which practitioners must tell the Secretary when notifying that they have supplied goods to their patients under the new scheme.
Therapeutic Goods (Medical Devices) Regulations 2002
Item 1 - Regulation 7.7
This item makes a minor editorial amendment to regulation 7.7 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Device Regulations) to reflect the changes introduced by the Amendment Act to allow the Minister to make a legislative instrument authorising the supply of unapproved medical devices by health practitioners under the new notification scheme.
Item 2 - At the end of Division 7.3 of Part 7
This item adds a new regulation 7.8 to the Device Regulations to introduce equivalent amendments for medical devices to those introduced for medicines by new subregulation 12B(6), and for biologicals by new subregulation 12C(5), in relation to the information health practitioners must submit as part of supplying unapproved devices under the new scheme (items 11 and 13 below refer).
Given the difference in the inherent nature of medical devices and the device regulatory scheme, there is a small number of different kinds of information to be notified for devices as compared to medicines or biologicals. These are, principally, the name of the manufacturer of the device, the manufacturer's intended purpose of the device and whether it is a device variant. For the purposes of the requirement in new subsection 41HC(6G) of the Act for the Minister to have regard to the principle that information should only be prescribed for the purposes of new paragraph 41HC(6C)(b) of the Act if it is reasonably required for the responsible scrutiny of the notification scheme, this information ensures that the TGA can verify that the devices being supplied under the new scheme are those that are authorised under the legislation.
Item 3 - Subregulation 8.2(2)
This item makes a minor amendment to subregulation 8.2 of the Device Regulations to, principally, replace a reference to "20 working days" with a reference to "28 days" to support greater consistency with other provisions in the Device Regulations (and the Principal Regulations). This is in the context of the requirement in regulation 8.2 for a medical practitioner who supplies a medical device to a Category A patient (one who is seriously ill with a condition reasonably likely to result in death within less than a year, or premature death in the absence of treatment) to send a signed statement to the Secretary after having done so.
Items 4 and 5 - Subclause 8(3) of Schedule 3A (paragraph (c) of the definition of authorised person, and at the end of that definition)
These items make minor amendments to subclause 8(3) of Schedule 3A to the Device Regulations. The effect is that if medical devices that are exempted from the requirement to be entered in the Register for use in a public health emergency, or so that they can be stockpiled in preparation for such an emergency, also come within the scope of devices able to be supplied by a health practitioner under the new notification scheme, the Secretary can direct such products to be given to the practitioner rather than being required to be destroyed if they are no longer needed for emergency purposes.
Item 6 - Dictionary
This item amends, consistent with an amendment which would be introduced to the Principal Regulations by item 7 below, the Dictionary in the Device Regulations to include a definition of "AHPRA number" (the registration number published by the Australian Health Practitioners' Regulation Agency in relation to the health practitioner). The defined term is included as information that a health practitioner must submit when notifying the TGA of having supplied unapproved medical devices to their patients in accordance with new regulation 7.8 (item 2 above refers). This provides a means of confirming that the health care practitioner is indeed registered to practice in Australia under an appropriate scheme.
Therapeutic Goods Regulations 1990
Item 7 - Regulation 2
Item 7 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations) to introduce a definition of "AHPRA number" consistent with that introduced to the Dictionary of the Device Regulations by item 6 above.
Items 8 and 9 - Subregulation 12A(3)
These two items make minor amendments to subregulation 12A(3) of the Principal Regulations, including to replace a reference to "4 weeks" with a reference to "28 days" to support greater consistency with other timeframes specified in the Principal Regulations. This is in the context of the requirement in subregulation 12A(3) for a medical practitioner who supplies a medicine or biological to a Category A patient (one who is seriously ill with a condition likely to result in imminent death, or premature death in the absence of treatment) to send the Secretary a signed statement after having done so.
Item 10 - Regulation 12B (heading)
This item makes a minor amendment to replace the current heading of regulation 12B of the Principal Regulations to reflect the changes made by item 11 below.
Item 11 - At the end of regulation 12B
This item amends regulation 12B of the Principal Regulations to add new subregulations 12B(5) and (6) to support the measures recently added to the Act by the Amendment Act to allow health practitioners to supply certain unapproved therapeutic goods to their patients by way of notification rather than requiring pre-approval from the Secretary.
Under new subsection 19(7A) of the Act (added by the Amendment Act), the Minister may make a legislative instrument authorising specified health practitioners (for example, medical practitioners or optometrists) to supply specified unapproved medicines to specified classes of recipients. In doing so, however, the Minister must comply with any restrictions prescribed by the regulations (paragraph 19(7B)(b) of the Act refers).
The effect of new subregulation 12B(5) is to set out, for the purposes of paragraph 19(7B)(b) of the Act, restrictions precluding the Minister from authorising in the new instrument the supply of any medicines that contain a substance in Schedules 8 (Controlled Drug), 9 (Prohibited Substance) or 10 (Substances of such danger to health as to warrant prohibition of sale, supply and use) of the Poisons Standard (a copy of the current Poisons Standard can be found at www.legislation.gov.au).
Under new subsection 19(7C) of the Act, if a health practitioner is authorised under the new instrument to supply medicines to their patients, they must notify the Secretary of having done so within 28 days of the supply. When doing so, the health practitioner must use the form approved for the purposes of paragraph 19(7D)(a), and include the information prescribed by regulations for the purposes of paragraph 19(7D)(b).
The effect of new subregulation 12B(6) would be to set out the information that a health practitioner must include when notifying the Secretary of this supply - this includes, for example, the patient's initials, date of birth and gender, each medical condition for which the practitioner supplied the product and each indication for which it was supplied, each of the medicine's active ingredients and the dosage form, the practitioner's name and AHPRA number and their health profession.
In determining this list of information, care has been taken to comply with the requirement in new subsection 19(7H) of the Act for the Minister, when recommending the making of regulations to the Governor-General, to have regard to the principle that information should only be prescribed for the purposes of paragraph 19(7D)(b) of the Act if it is reasonably required for the responsible scrutiny of the new notification scheme. For example, the amendments would only require the minimum amount of patient information - initials (rather than full name and/or address), date of birth and gender - considered necessary to be able to verify that practitioners are supplying medicines to the kinds of persons for whom they are authorised to do so under the Ministerial instrument. This information enables the TGA to better interpret reports of adverse events received on these medicines and their possible patterns - for example, is the medicine more likely to lead to adverse events on women and/or the elderly than the population as a whole. This is also consistent with the collection of such information from medical practitioners who are required to notify the Secretary of having supplied unapproved medicines and biologicals to Category A patients in accordance with regulation 12A of the Principal Regulations.
Item 12 - Regulation 12C (heading)
This item makes a minor amendment to replace the current heading of regulation 12C of the Principal Regulations to reflect the changes made by item 13 below.
Item 13 - At the end of regulation 12C
This item amends regulation 12C of the Principal Regulations to introduce equivalent amendments for biologicals to those that would be introduced for medicines by new subregulation 12B(6) above, in relation to the information practitioners must submit after having supplied unapproved biologicals under the new scheme (item 11 refers).
Items 14 -16 - Paragraph 47B(1)(c) and Paragraph 47B(5)(b)
Regulation 47B of the Principal Regulations principally requires sponsors and, in some cases, medical practitioners to provide 6 monthly reports to the Secretary on the supply of therapeutic goods that are exempt from the requirement to be entered in the Australian Register of Therapeutic Goods (the Register), or that are approved or authorised to be supplied while not entered in the Register.
Item 14 amends paragraph 47B(1)(c) to clarify that where unapproved therapeutic goods (including medicines, biologicals and medical devices) are supplied by health practitioners under the new notification scheme, sponsors' reports would also include the number of times that they have supplied goods to health practitioners and the kinds of goods involved.
It should be noted that the latter requirement would only apply to sponsors, not to health practitioners, and would cover the supply of such goods from the sponsor to the practitioner, for the purposes of later being supplied by the practitioner to their patient.
Item 15 and 16 make minor amendments to paragraph 47B(5)(b) of the Principal Regulations, to reflect this change of scope.
Item 17 - Schedule 5A (table item 1, column 2, after paragraph (c))
Item 1 of Schedule 5A to the Principal Regulations prescribes, for the purposes of subsections 18(1) and 32CA(2) of the Act, therapeutic goods that are exempt from (respectively) Parts 3-2 and 3-2A of the Act (principally, from the requirement to be entered in the Register). The effect of item 1 of Schedule 5A is to so exempt medicines and biologicals that are imported into Australia by the sponsor and held under their direct control, until the goods are covered by certain other exemptions - for example, where they are authorised by the TGA for supply to patients by a medical practitioner under subsection 19(5) of the Act.
Item 17 amends item 1 of Schedule 5A to also include as exempt from the requirement to be entered in the Register medicines or biologicals imported by sponsors and held under their direct control until those goods are authorised for supply under the Ministerial instruments made for the purposes of new subsections 19(7A) and 32CM(7A) of the Act (which underpin the new notification scheme for these products).
Goods are relevantly exempt from the requirement to be entered in the Register provided that, in accordance with the condition in paragraph (a) of column 3 of item 1, the relevant Ministerial instrument authorises their supply in respect of the kind of health practitioner that is requesting them and in respect of the kind of recipient for whom the practitioner advises the sponsor.
Items 18 and 19 - Subclause 8(3) of Schedule 5B (paragraph (b) of the definition of authorised person, and after paragraph (b))
These items make minor amendments to subclause 8(3) of Schedule 5B to the Principal Regulations, with the effect that if medicines and biologicals that are exempted from the requirement to be entered in the Register for use in a public health emergency, or so that they can be stockpiled in preparation for such an emergency, also come within the scope of goods able to be supplied by a health practitioner under the new notification scheme, the Secretary can direct such products to be given to the practitioner rather than being required to be destroyed if they are no longer needed for emergency purposes.
Schedule 3 - Permissible ingredients
These amendments relate to recommendation 47 of the Review to provide review and appeal rights for persons applying to add new ingredients for use in listed complementary medicines (Schedule 5 of the Amendment Act). These amendments would make minor, consequential amendments to the Principal Regulations to ensure that they refer to the correct provisions of the Act as amended following the commencement of the Amendment Act.
Therapeutic Goods Regulations 1990
Items 1 and 2 - Clause 3 of Schedule 9 (table items 7C and 7D, column 2)
Items 7C and 7D of Part 2 of Schedule 9 to the Principal Regulations set out evaluation fees relating to applications to vary the permissible ingredients legislative instrument. Currently, these refer to subsection 26BD(1) of the Act, which no longer exists, as the Amendment Act repealed section 26BD and replaced it with new section 26BE. Items 1 and 2 herein therefore make minor amendments to items 7C and 7D of Part 2 of Schedule 9 to reflect the changes to the Act.
Schedule 4 - Approval of medicines
These amendments relate to recommendation 3 of the Review, namely to establish new pathways for medicines to support earlier access for patients to certain new medicines which may have significant advantages over existing treatments, or which may provide a treatment option where there are no existing treatments, for life-threatening or seriously debilitating conditions (Schedule 6 of the Amendment Act). They amend the Principal Regulations to empower the Secretary to make therapeutic goods (priority applicant) determinations and related arrangements (for example, the criteria for qualifying for the new pathway and when such determinations may lapse or be revoked). The main effect is that where such a determination is made, assessment of the application for marketing approval for the particular product will be allocated greater resources and fast-tracked by the TGA, while continuing to be subject to all quality, safety and efficacy requirements under the Act (i.e. the same level of review as applications for other prescription medicines). Review and appeal rights will apply in relation to decisions to refuse to make a priority applicant determination and decisions to revoke such determinations.
Therapeutic Goods Regulations 1990
Item 1 - Regulation 2
This item amends regulation 2 of the Principal Regulations to introduce definitions of 'new prescription medicine', and 'new indications medicine' for the purposes of the criteria for medicines to qualify for a therapeutic goods (priority applicant) determination under new regulation 16R (item 2 below refers).
A 'new indications medicine' is defined as a prescription medicine that has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine in the Register, but that does not have the same indications as that existing medicine. Essentially, these are medicines that would represent an extension of indication (i.e. where a sponsor has an existing medicine that is registered in respect of indications a, b and c, and seeks a (priority applicant) determination in respect of new indication d).
A 'new prescription medicine' is, in summary, defined as either a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in the Register, or a fixed combination of chemical, biological or radiopharmaceutical active ingredients that includes at least one such active ingredient that has not itself previously been included in the Register.
This item also adds a definition of 'therapeutic goods (priority applicant) determination' for the purposes of the amendments in this Schedule, with that term having the meaning given by subsection 25AAA(2) of the Act.
Item 2 - After Part 3B
Item 2 introduces a new Part 3C to the Principal Regulations, which makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination for the purposes of subsection 25AAA(1) of the Act (added by Schedule 6 of the Amendment Act).
Application of new Part 3C - new regulation 16P
New regulation 16P makes it clear that new Part 3C applies in relation to the making of a therapeutic goods (priority applicant) determination for medicines.
Applications for therapeutic goods (priority applicant) determination - new regulation 16Q
New regulation 16Q would set out the requirements for persons applying to the Secretary for a therapeutic goods (priority applicant) determination - principally, these would be that the application must be in accordance with the relevant form approved by the Secretary, and must be accompanied by sufficient supporting information to allow the Secretary to properly consider the application. If these steps are not met, or if the prescribed application fee has not been paid (item 7 below refers), the application will be taken not to have been made.
Making of a priority applicant determination - new regulation 16R
New subregulation 16R(1) makes it clear that on receiving an application for a (priority applicant) determination that is in accordance with new regulation 16Q, the Secretary must consider the application and decide either to make the determination or refuse to do so.
New subregulation 16R(2) sets out the criteria for qualifying for a (priority applicant) determination, and would enable the Secretary to make a determination if (after having regard to any matter the Secretary considers relevant) he or she is satisfied that:
* either the medicine is a new prescription medicine or a new indications medicine (as defined - item 1 refers); and
* an indication of the medicine (the priority indication) relates to the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition; and
* either there are no therapeutic goods intended to treat, prevent or diagnose that condition already in the Register or, if there are, there is substantial evidence showing that the medicine provides a significant improvement in terms of efficacy or safety (or both) compared to those other goods; and
* there is substantial evidence showing that the medicine provides a major therapeutic advance. Major therapeutic advance is not defined in these amendments, but its meaning is explained in the TGA's guidance document, 'Priority Review Designation - Eligibility criteria and supporting documentation for sponsors' (available on the TGA's website www.tga.gov.au) as (essentially) an improvement in the safety and/or efficacy of a medicine that is well above the minimum threshold of clinical significance. In the context of an application for a therapeutic goods (priority applicant) determination, the evidence to support this must be substantial. This guidance document has been consulted upon with stakeholders.
One example of a likely major therapeutic advance is a new class of medicines known as PD1 or PDL 1 inhibitors, with potential for therapy in a wide range of cancers.
One or more products in this class may be considered a major therapeutic advance in a distinct subset of patients with non-small cell lung cancer (the most common form of lung cancer) who have not previously received treatment for advanced disease. The key study outcomes supporting the application to register this medicine may show a significant increase in overall survival compared to the patient group that received the current standard of care. At the same time, the safety profile may also be better.
Where the Secretary makes a (priority applicant) determination, the determination must set out the name of the priority applicant, and the active ingredient and the priority indication for the medicine to which it relates.
The Secretary must also notify the applicant in writing as soon as practicable after making a decision and, in the case of a refusal, provide reasons. Review and appeal rights would apply for sponsors whose applications are refused (items 5 and 6 below refer).
Period during which (priority applicant) determination is in force - new regulation 16S
New regulation 16S sets out that a (priority applicant) determination comes into force on the day the Secretary notifies the applicant of the decision to make the determination.
A (priority applicant) determination will, for a medicine for which the sponsor applies under section 23 of the Act to enter the medicine in the Register within 6 months of the determination coming effect, remain in force until either of the following occurs:
* a decision by the Secretary on the application to register the medicine is finally determined - i.e. when the Secretary decides to register the medicine under subsection 25(3) of the Act, or where the Secretary decides not to register the medicine under that provision and there is no longer any possibility of a change in the outcome of that decision; or
* the sponsor withdraws the application; or
* the application lapses under subsection 24(2) of the Act because the sponsor did not pay the relevant evaluation fee for the medicine; or
* the sponsor gives the Secretary notice under subsection 24E(2) of the Act that they wish to treat the application as having been refused.
For a medicine for which the sponsor has not applied under section 23 of the Act to enter the medicine in the Register within 6 months of the (priority applicant) determination coming into effect, the determination will remain in force until the end of that 6 month period.
This is designed to avoid delays and to support the efficient processing of medicines for which (priority applicant) determinations are made, so that they can be available for patients as soon as possible.
Revocation of (priority applicant) determinations - new regulation 16T
New regulation 16T sets out the instances in which the Secretary may revoke a (priority applicant) determination - principally, these are where:
* either the sponsor has not yet applied to register the medicine under section 23 of the Act, or has done so but that application is not effective for the purposes of section 23 (for example, where the sponsor has not paid the relevant application fee, or has not provided enough information to allow the Secretary to determine the application); and
* the Secretary is satisfied that the criteria for a (priority applicant) determination in sub-regulation 16R(2) (outlined above) are no longer satisfied in relation to the medicine.
Item 3 - After regulation 43AC
Item 3 introduces a new regulation 43AD to the Principal Regulations, which will apply where a sponsor applies for both a (priority applicant) determination and orphan drug status for their medicine. The new provision would require the Secretary to refund the application fee for a (priority applicant) determination where:
* the sponsor applies for a (priority applicant) determination at the same time as, or after, they apply for orphan drug status; and
* the Secretary designates the medicine as an orphan drug.
New subregulation 43AD(2) makes it clear that the Secretary is obliged to refund the fee for an application for a (priority applicant) determination in the above circumstances, irrespective of whether the Secretary makes a (priority applicant) determination in respect of the medicine. This is because the fee is waived in the case of medicines that have received an orphan drug designation from the Secretary.
Item 4 - At the end of subregulation 45(12)
Subregulation 45(12) of the Principal Regulations currently requires the Secretary to, principally, waive the application and evaluation fees that would otherwise be payable by a medicines sponsor for an application to register their medicine in the Register, if the Secretary has designated the medicine as an orphan drug under regulation 16J of the Principal Regulations.
Item 4 amends subregulation 45(12) to also require the Secretary to waive the application fee for a (priority applicant) determination for a medicine that is a designated orphan drug.
(Part 3B of the Principal Regulations sets out the current orphan drugs scheme, and Schedule 7 of these amendments specifies changes to this scheme - the reference above to regulation 16J of the Principal Regulations refers to this regulation as amended by these Regulations).
Items 5 and 6 - Regulation 48
These items amend regulation 48 of the Principal Regulations, to make it clear that a decision of the Secretary to refuse to make a (priority applicant) determination is subject to review and appeal rights for the unsuccessful sponsor, and that a decision of the Secretary to revoke a (priority applicant) determination will also be subject to review and appeal rights for the sponsor of the affected medicine.
Item 7 - Clause 3 of Schedule 9 (after table item 1)
This item introduces an application fee for sponsors applying for a (priority applicant) determination, in the amount of $12,300. This amount principally reflects the additional expected Departmental staff effort involved in relation to these applications, including that it is expected that TGA will hold meetings with sponsors about their applications to assist them to better understand the process and its requirements, and for TGA to assess the characteristics of the application that may warrant it being potentially granted priority status.
Items 8 - 13 - Clause 3 of Schedule 9
The table of fees in Part 2 of Schedule 9 to the Principal Regulations includes, at table items 2 and 4, a range of application and evaluation fees relating to applications to register medicines and therapeutic devices.
As part of the new (priority applicant) determinations arrangements, higher application and evaluation fees will apply for applications to register medicines that are covered by a (priority applicant) determination that is in force. Items 8-13 amend the table of fees in Part 2 of Schedule 9 to the Principal Regulations, to specify higher fees for this purpose, as set out in the following table:
| Table item for current fee: | Relates to: | Current fee: | New fee for medicines covered by a (priority applicant) determination: |
| 2(ba) | Application fee for the registration of a medicine that is a new chemical entity | $46,100 | $49,800 (this would be new table item 2(bca) |
| 4(a) | Evaluation fee for the registration of a medicine that is a new chemical entity | $185,100 | $199,000 (this would be new table item 4(ab) |
| 2(bd) | Application fee for the registration of a medicine that represents an extension of indication | $27,500 | $29,600 (this would be new table item 2(bfa) |
| 4(b) | Evaluation fee for the registration of a medicine that represents an extension of indication | $109,900 | $118,400 (this would be new table item 4(bd) |
In each case, the increase for these fees reflects both:
* an agreed increase of 1.65 per cent for financial year 2017-18, based on a long-standing indexation formula used to calculate adjustments to TGA fees and charges using the Australian Bureau of Statistics' Wage Price Index (50 per cent) and Consumer Price Index (50 per cent), both for the year to September 2016. The purpose of the change to annual fees and charges (which has been consulted upon and is supported by industry) is to help to ensure that the TGA is able to continue to recover its costs of administering the Act; and
* the additional staff effort expected to be involved for Departmental (TGA) staff for medicines that are in the new priority pathway.
Schedule 5 - Record-keeping
These amendments relate to recommendation 27 of the Review in relation to developing a more comprehensive post-market monitoring scheme for medicines in Australia (Schedule 8 of the Amendment Act). These amendments will, principally, require medicines sponsors to comply with the requirements set out in the TGA's pharmacovigilance guidelines in relation to record-keeping, as a condition of their registration or listing in the Register.
Therapeutic Goods Regulations 1990
Items 1 - 3 - Regulation 15A
Regulation 15A of the Principal Regulations currently requires medicines sponsors to comply with the requirements of the TGA document 'Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines' (as in force from time to time) in relation to pharmacovigilance reporting, as a condition of their registration or listing for the purposes of paragraph 28(5)(e) of the Act. This includes, for example, requiring sponsors to report adverse reactions and significant safety issues relating to their products, and to nominate a contact person within their organisation to the TGA for pharmacovigilance matters.
Schedule 8 of the Amendment Act added a new power for the regulations to prescribe record-keeping requirements for medicines sponsors, and items 1 and 2 amend regulation 15A of the Principal Regulations with the effect of requiring sponsors to also comply with this TGA document (as in force from time to time) in respect of record-keeping.
The 'Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines' does not currently apply any mandatory record-keeping requirements, however a proposed revised version, with such mandatory requirements, is expected to be the subject of targeted consultation with industry sponsors and peak bodies in June - July 2017, and finalised prior to the commencement of these regulatory amendments.
Item 3 also renames this document as 'Pharmacovigilance Responsibilities of Medicines Sponsors'.
Schedule 6 - Public notification and recalls
These amendments do not relate directly to the Review, but to the amendments in Schedule 10 of the Amendment Act that updated the terminology of the provisions in the Act that deal with the Secretary's power to recall therapeutic goods - principally, to replace references to "recovery" with "recall". "Recall" is considered to be a more contemporary and less ambiguous term than "recovery" for the kinds of actions the Secretary may take under the Act.
Therapeutic Goods (Medical Devices) Regulations 2002
Item 1
This item makes a number of minor, consequential amendments to Schedule 3 to the Device Regulations, to replace "recovery" with "recall" in that Schedule.
Therapeutic Goods Regulations 1990
Item 2
This item makes a minor, consequential amendment to subregulation 3A(2) of the Principal Regulations to replace "recovery" with "recall" in that subregulation.
Schedule 7 - Orphan drugs
These amendments relate to the introduction of measures to replace the current orphan drug scheme in Part 3B of the Principal Regulations with revised arrangements. An orphan drug is one used to treat, prevent or diagnose a rare disease - as currently provided for under the Principal Regulations, this means a disease affecting only a small number of Australian patients, currently up to 2,000.
The principal benefit of being an orphan drug is that the application and evaluation fees that would otherwise be payable for inclusion in the Register are waived under sub-regulation 45(12).
The current criteria for becoming an orphan drug have not been reviewed for 20 years, and do not reflect the growth of the Australian population, or industry changes, in that period.
These amendments better reflect population growth through changing the static number to a ratio. Expanding the 'population' related criterion for an orphan drug to cover medicine for the treatment, prevention or diagnosis of a condition affecting fewer than 5 in 10,000 individuals in Australia (this equates to approximately 12,000 Australians), potentially allowing more diseases to classify as rare in this context. Three additional criteria refocus the program to the consideration of the greatest unmet need. The new scheme is for medicines treating, preventing or diagnosing seriously debilitating or life threatening conditions. To qualify as an orphan drug under the new scheme there either is no registered treatment (prevention or diagnosis), or the medicine demonstrates significant benefit over registered treatments, with a medically plausible indication.
Therapeutic Goods Regulations 1990
Item 1 - Regulation 2
Item 1 amends the definition of a 'designated orphan drug' in regulation 2 of the Principal Regulations to reflect the changes made by item 4 below, principally in relation to providing, in new regulation 16K, for the period of time in which an orphan drug designation remains in force.
Item 2 - Regulation 2
This item introduces a new definition for 'new dosage form medicine' for the purposes of the changes that would be introduced by item 4 below. The new term means a medicine that has an indication in common with a medicine that is included in the Register and has the same chemical, biological or radiopharmaceutical active ingredients (or the same fixed combination of such ingredients) as that medicine, but that does not have the same dosage form as that existing medicine. For example, a medicine currently only available in tablet form that is proposed to be available in syrup would be a new dosage form medicine.
Item 3 - Regulation 2
Item 3 repeals the current definitions of 'orphan drug' and 'rare disease' from regulation 2 of the Principal Regulations, as these are redundant in light of the changes made by item 4 below.
Item 4 - Part 3B
This item repeals the provisions in the Principal Regulations that underpin the current orphan drug scheme (Part 3B of those regulations), and replaces them with revised arrangements in a new Part 3B.
Application to designate medicine as orphan drug - new regulation 16H
New regulation 16H allows medicines sponsors to apply to the Secretary for the designation of their medicine as an orphan drug and would require sponsors to use the form approved by the Secretary for doing so.
Secretary must decide whether to designate - new regulation 16J
Once in receipt of an application under regulation 16H for a medicine, new regulation 16J requires the Secretary to consider the application and decide either to designate the medicine as an orphan drug, or to refuse to do so. A decision by the Secretary to refuse to designate will be subject to review and appeal rights (item 6 below refers).
Under new subregulation 16J(2), the Secretary may decide to designate a medicine as an orphan drug if satisfied, having regard to any matter the Secretary considers relevant, that the medicine satisfies all the criteria set out in new subregulation 16J(3), or for a new dosage form medicine, all the criteria set out in new subregulation 16J(4).
For medicines that are not new dosage form medicines, these criteria, cumulatively, are that:
* the application is for only one indication for the medicine; and
* the medicine's indication is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition in a particular class of individuals (the relevant patient class); and
* it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another patient class. The intention of this criterion is to exclude from this avenue of qualifying for orphan drug designation medicines that would likely be effective in an overall sense in treating, preventing or diagnosing individuals in other patient classes than the one in relation to which orphan designation has been sought. Medical plausibility is also considered as part of the European Medicines Agency (EMA) orphan designation process. The medicine's indication is medically plausible if:
o the medicine will be effective in the treatment, prevention or diagnosis of the condition; and
o if the condition is a subset of a condition affecting a larger population, the medicine would not be effective for the larger population;
* at least one of the following applies:
o for a medicine intended to treat the condition - the condition affects fewer than 5 in 10,000 individuals in Australia (as at the time the orphan drug application is made); or
o for a medicine intended to prevent or diagnose the condition - the medicine would (if included in the Register) not be likely to be supplied to more than 5 in 10,000 individuals a year in Australia; or
o it is not likely to be financially viable for the sponsor to market the medicine in Australia if the application and evaluation fees to register the medicine were not waived; and
* the medicine has not been refused approval for the treatment, prevention or diagnosis of the condition for reasons relating to safety by the Secretary, the United States Food and Drug Administration, the European Medicines Agency, Health Canada or the Medicines Healthcare products Regulatory Agency of the United Kingdom; and
* either there are no therapeutic goods that are intended to treat, prevent or diagnose the condition included in the Register or, if there are such goods already in the Register, the medicine the subject of the orphan application would provide a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or provide a major contribution to patient care, over those existing products ('major contribution to patient care' still relates to a medicine's relative overall contribution to treatment, prevention or diagnosis of the relevant condition - an example would be a medicine that takes the form of a tablet which can be taken by a person in their own home, compared to existing products which can only be taken by intravenous route in a healthcare setting. This term is not, for example, concerned with the affordability of patient care).
Guidance material with more information about orphan drugs, including in relation to explaining medical plausibility, is available at the TGA's website, www.tga.gov.au.
For medicines that are new dosage form medicines, these criteria, cumulatively, are that:
* the application is for only one indication for the medicine; and
* the medicine's indication is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition; and
* it is not likely to be financially viable for the sponsor to market the medicine in Australia if the application and evaluation fees to register the medicine were not waived; and
* the medicine has not been refused approval for the treatment, prevention or diagnosis of the condition for reasons relating to safety by the Secretary, the United States Food and Drug Administration, the European Medicines Agency, Health Canada or the Health Medicines and Healthcare products Regulatory Agency of the United Kingdom; and
* either there are no therapeutic goods intended to treat, prevent or diagnose the condition included in the Register or, if there are such goods already in the Register, the medicine the subject of the orphan application would provide a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or provide a major contribution to patient care (see above example of this), over those existing goods.
After making a decision on the application, the Secretary must notify the applicant of the decision and, in the case of a refusal, provide reasons. The Secretary must also publish a notice on the Department's website noting details of the decision, for example, that the medicine has been designated as an orphan drug.
Period during which designation is in force - new regulation 16K
Under new regulation 16K, an orphan drug designation comes into force when it is made by the Secretary, and remain in force for 6 months - though it is important to note that this is subject to new regulations 16L (application for 6 month extension of designation) and 16M (revocation of designation).
Application for extension of designation - new regulation 16L
Where an orphan drug designation is in force and there are at least 28 days before it will no longer be in force under regulation 16K (see above), new subregulation 16L allows the sponsor to apply to the Secretary for an extension of the designation period for a further 6 months. On receipt of an application for an extension, the Secretary will be required to decide either to extend the designation, or refuse to do so. A decision to refuse to extend will be subject to review and appeal rights (item 6 below refers).
Under new subregulation 16L(4), the Secretary may only extend an orphan drug designation if:
* the Secretary has not previously extended the designation (i.e. would have the effect that an orphan drug designation may only be extended once);
* the Secretary is satisfied that the sponsor would, if the designation were extended, apply to register the medicine in respect of the relevant indication (or a subset of that indication) before the end of the extension;
* the Secretary is satisfied that the medicine still satisfies the criteria in paragraphs 16J(3)(e) and (f) for a medicine which is not a new dosage form medicine, or in paragraphs 16J(4)(d) and (e) for a medicine which is a new dosage form medicine (i.e. that the medicine has not been refused approval for the relevant condition by the Secretary or in the United States, Europe, Canada or the United Kingdom, and that either there are no medicines with indications for the treatment, prevention or diagnosis of the same condition on the Register or, if there are medicines already in the Register with such indications, the medicine the subject of the orphan application would provide a significant benefit over those existing products).
After making a decision on the extension application, the Secretary must notify the applicant of the decision and, in the case of a refusal, provide reasons.
Revocation of designation - new regulation 16M
New regulation 16M allows the Secretary to revoke an orphan drug designation if either the sponsor of the medicine asks for it to be revoked, or if the Secretary is satisfied that the medicine no longer satisfies the eligibility criteria (outlined above) - this might happen if, for example, after being designated by the Secretary as an orphan drug, the medicine is refused approval for the treatment of the relevant condition by the European Medicines Agency for a reason relating to the medicine's safety.
A decision of the Secretary to revoke an orphan drug designation will be subject to review and appeal rights (item 6 below refers).
Item 5 - Paragraphs 45(12)(a) and (b)
Paragraphs 45(12)(a) and (b) require the Secretary to waive fees associated with applying for the designation of a medicine as an orphan drug, and with the Secretary considering such applications. However, there are no fees prescribed in the Principal Regulations for the purposes of these paragraphs, and it is not intended to apply such fees for applying for orphan drug designation. Accordingly, item 5 repeals these two paragraphs.
Item 6 - Subregulation 48(1) (paragraph (e) of the definition of initial decision)
Regulation 48 of the Principal Regulations provides for review and appeal rights in respect of a range of specified decisions that may be made under those regulations - such decisions are defined as 'initial decisions' in subregulation 48(1).
This item amends subregulation 48(1) of the Principal Regulations, with the effect of providing for 3 new decisions of the Secretary under the new Part 3B to be 'initial decisions' and therefore subject to review and appeal rights - a decision to refuse to designate a medicine as an orphan drug, a decision to refuse to extend the designation period and a decision to revoke an orphan drug designation.
Schedule 8 - Miscellaneous amendments
These amendments principally prescribe conditions that are automatically applied on inclusion in the Register for medical devices, for the purposes of new subsection 41FN(5A) of the Act (added by Schedule 12 of the Amendment Act). These amendments do not introduce any new requirements, but rather provide a more transparent, comprehensive way of setting of these out. This Schedule also contains a small number of minor measures relating to medical devices that are not related to the Amendment Act.
Therapeutic Goods (Medical Devices) Regulations 2002
Item 1 - At the end of Division 5.2 of Part 5
New regulation 5.9 - storage and transport
This regulation makes it clear that it is a condition of inclusion of a kind of medical device in the Register that the sponsor ensure that, while they have control over a device of that kind, it is stored and transported in accordance with any instructions for use or other information provided by the manufacturer of the device.
New regulation 5.10 - record-keeping
This regulation makes it clear that it is a condition of inclusion of a kind of medical device in the Register that the sponsor create a record of:
* information referred to in regulation 5.8 of the Device Regulations (essentially, this is information that the sponsor is aware of and that relates to any malfunction, deterioration or inadequacy of the kind of device), as soon as they are aware of such information; and
* information relating to the distribution of each device of that kind, as soon as practicable after the distribution.
Sponsors are required, under new regulation 5.10, to retain such records for 10 years in the case of certain higher risk kinds of devices (Class AIMD, Class III and Class IIb devices, and Class 4 in vitro diagnostic (IVD) medical devices). For any other kinds of devices, sponsors would be required to retain such records for 5 years.
New regulation 5.11 - reporting
This regulation makes it clear that it is a condition of inclusion of a Class AIMD, Class III or Class IIb medical device that is an implantable medical device, or a Class 4 IVD, in the Register that the sponsor provide the Secretary with a report relating to certain matters before 1 October following each 'reporting period'.
Such reports must include whether the kind of device was supplied in Australia or a foreign country during the reporting period, any information referred to in regulation 5.8 of the Devices Regulations of which the sponsor became aware during the reporting period, or a statement to the effect that the sponsor was not aware of any such information during that time.
The 'reporting period' is defined in new subregulation 5.11(4) as, effectively:
* the period from the day the kind of device was included in the Register to the next 30 June - for example, 31 December 2017 (date of inclusion in the Register) to 30 June 2018;
* each of the two subsequent financial years - in the above example, this would be 1 July 2018 to 30 June 2019, and 1 July 2019 to 30 June 2020.
New regulation 5.12 - notification of information relating to certain IVDs
This regulation applies to certain kinds of IVDs - those referred to in paragraph 5.3(1)(j) of the Devices Regulations. These relate to IVDs that are for a range of specific purposes, such as for example self-testing, point of care testing or detecting the presence of or exposure to a sexually transmitted agent.
This regulation makes it clear that it is a condition of inclusion of one of these kinds of IVD in the Register that if the sponsor intends to import, supply or export a device of that kind, and the product name or the manufacturer's intended purpose of the device are not included in the relevant Register entry, that the sponsor give the Secretary a written notice specifying the product name and manufacturer's intended purpose of the device at least 20 business days before the intended import, supply or export.
Items 2 and 3 - Regulation 10.6A
The purpose of regulation 10.6A of the Devices Regulations is to prescribe the persons to whom the Secretary may delegate his or her power under section 41HD of the Act to approve the importation or supply of unapproved medical devices if devices that could act as a substitute are unavailable or in short supply. Previously under subsection 57(9) the Act, this power could only be delegated to the National Manager of the TGA or a person holding, occupying or performing the duties of a prescribed position in the TGA. The Amendment Act substituted a new subsection 57(9) to reflect that the position of National Manager no longer exists, in light of restructures in recent years.
These items therefore make a minor amendment to regulation 10.6A to reflect the changes made by the Amendment Act by replacing the current reference in regulation 10.6A to paragraph 57(9)(b) of the Act with a reference to subsection 57(9), and also replace the reference in paragraph 10.6A(c) to the "Regulatory Services Group" with a reference to the "Health Products Regulation Group" to reflect a recent name change.
Items 4 and 5 - Part 1 of Schedule 4 (table item 1.3)
These items amend table item 1.3 of the table in Part 1 of Schedule 4 to the Devices Regulations, which sets out certain kinds of medical devices that are exempt from the requirement to be included in the Register. The effect of these amendments is to make it clear that medical devices imported into, exported from, or supplied or manufactured in, Australia, which are not supplied for use in or on a human being, will be so exempt if they are for:
* evaluation;
* use in the manufacture of goods including therapeutic goods; or
* testing performed on a specimen taken from a cadaver (other than to assess whether a part of the cadaver is suitable for transfusion or transplantation).
Item 6 - Part 1 of Schedule 5 (before table item 1.7)
The Amendment Act amended the Act to introduce new section 41GLB, under which the Secretary may, in effect, reinstate an entry in the Register for a kind of medical device if the entry was cancelled because the sponsor did not pay the applicable annual charge for the entry within 20 working days of the charge becoming due and payable. Under the new section, the Secretary may do so before the end of 90 days after the cancellation, and provided the sponsor has paid the annual charge and any prescribed application fee. This item amends Schedule 5 to the Device Regulations to prescribe an application fee for that purpose, being a fee of $150 if the reinstatement request relates only to one entry and, where such a request relates to more than one entry, a fee of $150 for the first entry plus $50 for each additional entry.
Therapeutic Goods Regulations 1990
Item 7 - Subregulation 46A(2)
The purpose of subregulation 46A(2) of the Principal Regulations is to prescribe the persons to whom the Secretary may delegate his or her power under sections 19A and 32CO of the Act to approve the importation or supply of unapproved medicines or biologicals if products that could act as a substitute are unavailable or in short supply. Previously under subsection 57(8) the Act, this power could only be delegated to the National Manager of the TGA or a person holding, occupying or performing the duties of a prescribed position in the TGA. The Amendment Act substituted a new subsection 57(8) to reflect that the position of National Manager no longer exists, in light of restructures in recent years.
These items therefore make a minor amendment to subregulation 46A(2) to reflect the changes made by the Amendment Act by replacing the current reference in subregulation 46A(2) to paragraph 57(8)(b) of the Act with a reference to subsection 57(8),
Items 8 and 9 - Clause 3 of Schedule 9 (before table item 6C) and Part 2 of Schedule 9A (before table item 17)
These items amend the table at Part 2 of Schedule 9 to the Principal Regulations, and the table at Part 2 of Schedule 9A to the Principal Regulations to introduce equivalent application fees to those that would be added by item 4 above for, respectively, registered and listed therapeutic goods, and biologicals.
Schedule 9 - Transitional provisions
Therapeutic Goods Regulations 1990
Item 1 - In the appropriate position in Part 9
This item adds a new Division 5 to the Principal Regulations to provide transitional arrangements relating to these amendments.
New regulation 52
New regulation 52 sets out a definition for '2017 Amendment Regulations' (being, these amendments), and for 'commencement day' (being, the day on which Part 1 of Schedule 1 of these amendments commence - 1 July 2017).
New regulation 53
New regulation 53 would have the effect that, despite the amendments made by Schedule 3 to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017, the evaluation fees prescribed in items 7C or 7D of Part 2 of Schedule 9 to the Principal Regulations, as in force immediately before the commencement of Schedule 5 of the Amendment Act, will continue to apply to outstanding applications for which the evaluation fee had not been paid.
New regulation 54 - Existing orphan drug designations
Under new regulation 54, any medicine, vaccine or in vivo diagnostic agent designated as an orphan drug under the current regulation 16J of the Principal Regulations - i.e. regulation 16J as set out immediately before the commencement of these amendments - will continue in force for 12 months beginning on that commencement (i.e. from 1 July 2017).
New regulation 55 - Pending orphan drug designation applications
If, before the commencement of these amendments, a sponsor has applied to the Secretary for a medicine, vaccine or in vivo diagnostic agent to be designated as an orphan drug under the current regulation 16I of the Principal Regulations (i.e. regulation 16I as set out immediately before the commencement of these amendments) and the application has not been finally determined, then the current Part 3B and regulation 48 of the Principal Regulations will continue to apply to that application after the commencement of these amendments.
Where, for such an application, the medicine, vaccine or diagnostic agent is designated as an orphan drug under the current regulation 16J after the commencement of these amendments (in reliance on this transitional provision), the designation will come into force when it is made, and would continue in force for 12 months from the commencement of these amendments. While in force, new regulation 43AD will apply to the medicine as if the medicine were designated as an orphan drug under the new regulation 16J. This will have the effect that if the sponsor applies for a therapeutic goods (priority applicant) determination in respect of the medicine after the commencement of these amendments and pays the application fee for seeking such a determination, the Secretary will be required to refund that fee if the Secretary later designates the medicine as an orphan drug.
New regulation 56 - fee waivers in relation to certain designations
New regulation 56 applies in relation to a designation of a medicine as an orphan drug in force under new regulations 54 or 55 above. Under regulation 56(2), such a medicine, vaccine or in vivo diagnostic agent would be taken to be a designated orphan drug for the purposes of paragraphs 45(12)(c) and (d) of the Principal Regulations (waiver of application and evaluation fees for applying for the registration of a medicine in the Register, and waiver of (priority applicant) determination fees) and items 1 to 2B in Part 1, and Part 3, of Schedule 3 to the Principal Regulations (requirement to be included in the part of the Register for registered goods, in respect of medicines).
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
The Amendment Regulations are compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Amendment Regulations are made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act). They amend the Therapeutic Goods Regulations 1990 (the Principal Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Device Regulations). These amendments take effect on 1 July 2017, except in the case of amendments relating to variations to entries on the Register for prescription medicines, which take effect on 1 January 2018.
The Therapeutic Goods Amendment (2016 Measures No.1) Act 2017 (the Amendment Act) recently amended the Act to, in particular, support the implementation of several key recommendations of the Expert Panel Review of Medicines and Medical Device Regulation (the Review) agreed to by the Australian Government in its response to the Review (see www.tga.gov.au). The Expert Panel was established to, principally, identify areas of the regulation of medicines and medical devices which could be streamlined while maintaining the safety and quality of therapeutic goods in Australia, and made 58 recommendations. The Australian Government supported 56 of the 58 recommendations for reform, and the Amendment Act addressed a first tranche of these recommendations.
A number of the Review measures supported by the Amendment Act required the making of regulations to support implementation. These include:
* providing a new pathway for the priority review by the TGA of particular prescription medicines that represent a major therapeutic advance over currently-available treatments;
* allowing industry sponsors of medicines that are currently registered by the TGA to make straightforward, low-risk variations to their medicines (where product safety, quality or efficacy is not impacted) by notification to the TGA, rather than (as previously) requiring TGA pre-approval for these changes;
* enabling health practitioners to supply certain unapproved therapeutic goods - principally those with an established history of use in similar overseas countries - to their patients by way of notification to the TGA, rather than (as previously) requiring pre-approval; and
* enhancing the monitoring of the safety of products once on the market by providing for the introduction of record-keeping requirements for medicines sponsors.
The Amendment Regulations amend the Principal Regulations and the Device Regulations for the above purposes - for example, by setting out the arrangements for priority review of prescription medicines (including the criteria for medicines to qualify for this new pathway, the length of time a priority determination remains in place and the grounds on which such a determination may be revoked), listing the variations that medicines sponsors may notify to the TGA without the need for pre-approval and specifying the information that health practitioners must give the TGA as part of being able to supply unapproved therapeutic goods to their patients under the new notification arrangements.
The Amendment Regulations also introduce a small number of new fees to support the above measures, including for example, application fees for sponsors who apply to access the new priority approval pathway for prescription medicines.
In addition, one Review measure that was reflected in the Amendment Act - the introduction of review rights for persons who apply for the approval of new ingredients for use in listed complementary medicines - requires a minor, consequential amendment to the Principal Regulations to ensure that they refer to the correct provision of the Act as amended.
The Amendment Regulations also amend the Principal Regulations to introduce a revised "orphan" drug scheme to update the criteria for medicines to become orphan drugs and reflect population growth and improvements in technology used to diagnose and identify rare diseases, and in the ability to tailor related therapies, since the previous orphan drug scheme was introduced 20 years ago.
The Amendment Regulations also amend the Device Regulations to prescribe standard conditions for medical devices (these do not include any new requirements for medical device sponsors, but rather provide a clearer, more transparent view of the previously applicable conditions) and to make a small number of other, minor clarifications and corrections.
Human rights implications
As the Amendment Regulations do not introduce any changes to the Principal Regulations or the Device Regulations other than to implement the changes mentioned above, they do not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Greg Hunt, Minister for Health
Commonwealth Numbered Regulations - Explanatory Statements