Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 192

Statutory Rules 1995 No. 192

Issued by Authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to 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) has the responsibility of administering the Act. The TGA operates from the Therapeutic Goods Administration Trust Account, established under the Audit Act 1901 and referred to in Section 45 of the Act. In accordance with the Government's decision of August 1989, the TGA is required to operate on a fifty per cent costrecovery basis, with funding raised through fees and charges collected from industry.

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

Subsection 63(1) and paragraphs 63(2)(h) and 63(3)(a) of the Act enable the Governor-General to 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. Paragraph 63(3)(b) provides that regulations may also be made for the refund, reduction or waiving of fees or charges in cases identified in the Regulations.

The fees and charges set out under Schedule 9 of the Therapeutic Goods Regulations and under the Therapeutic Goods (Charges) Regulations were structured with the aim of meeting the fifty per cent cost-recovery objective for the TGA. However, since the Act came into operation on 15 February 1991, this goal has not been met

To address the shortfall in revenue, a Budget Working Party, with a membership drawn from the Australian Pharmaceutical Manufacturers Association Inc, the Proprietary Medicines Associations of Australia Inc, the Medical Industry Association of Australia Inc, the Nutritional Foods Associations and the TGA, was set up on 20 March 1993 to canvas various options. Following meetings and considerable discussion by the group, the option of increasing fees and charges under the Therapeutic Goods Regulations and the Therapeutic Goods (Charges) Regulations, as well as the introduction of new fees to cover activities previously undertaken by TGA free of charge, wore considered to be the most appropriate options to adopt for achieving the fifty per cent cost recovery target set by the Government. To achieve this objective with the minimum of disruption to the industry, agreement was reached between industry and government that the increases would be progressively phased in over a four year period, beginning with the 1993/94 financial year. The first set of increases and new fees were accordingly effected on 1 July 1993.

The proposed Regulations:

(a)       provide for the third agreed incremental increase to the existing range of application fees, processing fees and evaluation fees currently applying under Schedule 9 of the Regulations;

(b)        provide a mechanism for sponsors of therapeutic devices to pay reduced evaluation fees for registration or variation of their therapeutic device where the Secretary has information relating to those devices that would allow evaluations of applications to be abridged;

(c)        provide a mechanism for sponsors of therapeutic devices to pay reduced evaluation fees for registering, or varying information relating to, their therapeutic devices when they lodge concurrent applications, and the information supporting the application is sufficiently similar in respect of the devices to enable in evaluation of all the goods to be made simultaneously,

(d)        provide for applicants applying under the Act to register therapeutic devices to pay their evaluation fee by three instalments, subject to conditions, if the fee is over $10,000 and payment of the fee in a lump sum would cause financial hardship;

Further details of the proposed Regulations are set out in the Attachment.

The proposed Regulations commenced on 1 July 1995.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides that the changes contained in these Regulations are to commence on 1 July 1995.

Regulation 2 states the Therapeutic Good Regulations are amended as set out in these amending Regulations.

Subregulation 3.1 inserts new subregulation 45(4A). Subregulation 45(4) currently enables the Secretary to exercise his discretion in waiving or reducing evaluation fees for registrable therapeutic goods where the information submitted in support of an application for registration or variation allows the evaluation to be abridged. Subregulation 45(4A) replaces the Secretary's discretion with specified reduced amounts to be payable by an applicant who lodges an application to register devices.

If the Secretary reduces the evaluation fee payable on an application to register a therapeutic device, the amount payable for each application will be:

•	for each category of data relating to design, materials or testing:	$2,700
•	for each category of data relating to manufacture, quality control or sterility:	$1,600
•	for each category of data relating to biocompatibility, pre-clinical information or testing information:	$2,400
•	for data relating to human clinical data:	$9,500
•	confirmatory review of clinical information	$3,200

Subregulations 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7 specify the incremental increases to the reduced evaluation feet payable by persons who lodge concurrent applications to register drugs under the Act.

Subregulation 3.8 inserts new subregulation 45(8), 45(9), 45(10) and 45(11) prescribing reduced evaluation fees payable by applicants who lodge concurrent applications to either register therapeutic devices (of a kind referred to in Part 1 of Schedule 3 of the Regulations) or vary information on therapeutic devices contained in the Australian Register of Therapeutic Goods (the Register). Previously, only concurrent applications to register drugs processed by the Drug Safety and Evaluation Branch attracted reduced evaluation feet.

For concurrent applications, the fee for each application (other than the principal application) to register a therapeutic device will be reduced as follows:

•	evaluation of any or all data relating to design, materials or testing:	Total of:	$2,700
•	evaluation of any or all data relating to manufacture, quality control or sterility:	Total of:	$1,600
•	evaluation of any or all data relating to biocompatibility or pre-clinical or testing information:	Total of:	$2,400
•	evaluation of human clinical data:	Total of:	$3,200

As is the cat for Schedule 10 drugs, multiple applications must be concurrently lodged by the same applicant and the class of information lodged (as identified above) must be similar to enable that class of information relating to the same class of devices to he evaluated simultaneously.

Reduced evaluation fees payable for the evaluation of concurrent applications to vary information about devices contained in the Register will be:

•	for a review of any or all data relating to design, materials information or testing:	Total of:	$900
•	for a review of any or all data relating to manufacture, quality control or sterile manufacture or testing information:	Total of:	$550
•	for a review of any or all data relating to biocompatibility or pre-clinical information:	Total of:	$800
•	for a review of human clinical data:		$3,200

Again, multiple applications must be concurrently lodged by the same applicant, and the class of information lodged (as identified above) must be, similar to enable that class of information relating to the same class of devices to be evaluated simultaneously.

Regulation 4 inserts a new Regulation 45AA that permits sponsors applying under section 23 of the Act to register therapeutic devices to pay their evaluation fees by instalments where the total evaluation fees payable exceed $10,000 and the applicant satisfies the Secretary that payment of the lump sum would cause financial hardship.

The Secretary may permit the full amount of the evaluation fees set out under Item 6 or 7 of Schedule 9 to be paid in three instalments: 50% payable before the commencement of the evaluation 25% payable within one month of the day on which the first instalment was payable, the remaining 25% payable if the application is rejected during the evaluation, at completion of the evaluation, before the device is registered or where the application is withdrawn. Sponsors who apply to pay by instalments must state the reasons why the payment of the entire fee prior to commencement of the evaluation would cause financial hardship, and provide documents and other information to support the application. The Regulations also provide that in applicant is not allowed to pay by instalments if the applicant has not paid any outstanding evaluation fees still payable by the applicant for any other application lodged under section 23 or section 32 of the Act on that application. Furthermore, where an applicant has failed to pay any instalment owing on a current application by the due date, the applicant forfeits the right to pay by instalments and must forthwith pay the entire amount owing.

Regulation 5 amends regulation 48 to include a reference to new regulation 45AA, so that decisions made in relation to applications for payment by instalments can be reviewed by the Minister and then the AAT.

Subregulation 6.1 inserts Item 2 (g)(i) and (ii) which provides a new application fee to he included in Schedule 9 for processing concurrent applications to vary information contained in the Register relating to devices. The new fee will be $360.

Subregulation 6.2 inserts Item 3A which provides for a new fee of $300 for each toxicology evaluation conducted by the Drug Safety and Evaluation Branch for an application under section 23 of the Act which has been referred to it by the Compliance Branch of the TGA.

Subregulations 6.3, 6.4, 6.5 and 6.7 set out the table of increases to the fees currently applying under Schedule 9 of the Therapeutic Goods Regulations. These changes have been agreed to by industry and represent the third incremental increase to the fees and charges that are being introduced over a four year period.

Subregulation 6.6 removes Item 15 from Schedule 9 relating to payment of a half-day evaluation fee for therapeutic devices.