Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1998 NO. 247

STATUTORY RULES 1998 NO. 247

Issued by authority of the Minister for Health and Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 63 of the Act provides that the Governor-General may make regulations for the purposes of the Act.

The Governor-General may make regulations prescribing a range of application, processing or evaluation fees payable in connection with the processing of applications to include therapeutic goods in the Australian Register of Therapeutic Goods (the Register) and the variation of information contained in the Register about those goods - subsection 63(1) and paragraphs 63(2)(h) and 63(3)(a). Fees maybe prescribed for the evaluation of data concerning therapeutic goods or the inspection of manufacturing operations - paragraphs 63(2)(g) and (h). Regulations may also be made for the refund, reduction or waiving of fees or charges in cases identified in the Regulations - paragraph 63(3)(b).

The purpose of the regulations is to implement the final stage of the decision that TGA is to recover from industry the total cost of the regulation of therapeutic goods. To achieve 100% cost recovery it is necessary to increase a range of fees and charges. To minimise the impact on industry of the increases in charges, industry and Government agreed to phase in these increases. In framing the 1997/98 Budget, Government decided to increase the level of cost recovery from 75% in 1997/98 to 100% in 1998/99. TGA has consulted with industry about the increases.

The increases in fees contained in the proposed regulations have been made in conjunction with the increases in charges made under the accompanying Therapeutic Goods (Charges) Regulations (Amendment),

Details of the Regulations are set out in the Attachment.

The Regulations commence on 1 August 1998.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides for the Regulations to commence on 1 August 1998.

Regulation 2 provides for the Therapeutic Goods Regulations to be amended as set out in these Regulations.

Subregulation 3.1 increases the amount of the prescribed reduced evaluation fees payable under subregulation 45(4A) in certain circumstances

Subregulation 3.2 removes subregulations 45(5), (6) and (7) that provided for different reduced evaluation fees for related applications to register certain drugs.

Subregulation 3.3 has the effect of increasing the discounted fees payable under subregulations 45(8) and (9) that involve evaluating related applications to register therapeutic devices.

Subregulation 3.4 increases the amounts of a range of application fees payable under subregulation 45(11) for processing applications to vary information about therapeutic devices.

Subregulation 4.1 removes application fees for applications that incur an evaluation fee for evaluating chemistry, quality control and manufacturing information.

Subregulation 4.2 increases the amounts of a range of application fees for the registration of therapeutic goods and fees for evaluating therapeutic goods that are to be imported or exported for experimental purposes in humans where those goods are not registered, listed or exempt goods.

Subregulation 4.3 increases the application fees where a previous registration was cancelled solely because the sponsor of the cancelled goods failed to pay an annual charge, and where the application to reregister the goods is made within 30 days of the cancellation..

Subregulation 4.4 has the effect of increasing the fees for varying an entry in the Register.

Subregulation 4.5 increases the application fees for listing therapeutic goods.

Subregulation 4.6 increases the application fees where a previous listing was cancelled solely because the sponsor of the cancelled goods failed to pay an annual charge, and where the application to re-list the goods is made within 30 days of the cancellation..

Subregulation 4.7 removes what was an unnecessary item for a toxicology evaluation.

Subregulation 4.8 has the effect of increasing the evaluation fees for therapeutic goods that are evaluated by the Drug Safety and Evaluation Branch of TGA.

Subregulation 4.9 inserts a new item into Schedule 9 to cover the administrative costs incurred where an application for the registration of a prescription drug is rejected or withdrawn before acceptance for evaluation. A new item is necessary as application fees for prescription drugs that previously would have recovered these costs have be abolished.

Subregulation 4.10 increases licence application fees and fees for evaluating:

*       therapeutic devices listed in Part 2 of Schedule 33 that attract lower fees

*       whether good manufacturing practices have been adopted for therapeutic goods wholly

       or partially made outside Australia

*       data concerning applications to vary an entry in the Register for either types of these

       goods.

Subregulation 4.11 increases the fees for evaluating.

*        therapeutic goods that are not covered by item 4 of Schedule 9 or variations of an

       entry in the Register for these goods

*        therapeutic devices listed in Part 1 of Schedule 3 that attract higher fees, or changes in

       these types of devices, where that involves evaluating the matters listed in item 6 of

       Schedule 9

*       overseas data supporting applications to register a device.

Subregulation 4.12 has the effect of introducing one uniform hourly rate for inspections in Australia and another uniform rate for overseas inspections to ensure that licence holders maintain good manufacturing practices.

Subregulation 4.13 increases the fees for evaluating steps in the manufacture of therapeutic goods by reference to what is commonly called the plant master file.

Subregulation 4.14 increases the application fee for certification under the World Health Organisation Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

Subregulation 4.15 has the effect of introducing one uniform fee for notifying an intention to sponsor a clinical trial of a specified drug. The fee is set at the old fee for a trial by 1 body. A higher fee for a trial by more than 1 body is abolished.

Subregulation 4.16 corrects an erroneous reference in item 14A of Schedule 9 to 'drug' so that it reads 'device'.

Subregulation 4.17 increases the fee for notifying an intention to sponsor a clinical trial of a specified therapeutic device.