Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1992 NO. 109

EXPLANATORY STATEMENT

STATUTORY RULES 1992 No. 109

Issued by Authority of the Minister for Aged, Family and Health 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 exported from Australia.

Paragraph 63(2)(da) of the Act relevantly provides that the Governor-General may make regulations, not inconsistent with the Act, providing for periods within which evaluations of specified registrable goods, or a specified registrable class of goods, are to be completed.

Background

The Therapeutic Goods Regulations (Amendment), Statutory Rules No. 19 of 1992 (the amending Regulations), set out time limits within which evaluations, under section 25 or subsection 32(5) of the Act, of a specified class of registrable drugs must be completed. In setting out the time limits, the amending Regulations also specifies when the time limit begins and ends, and the circumstances in which the time limits may be reduced. Following discussions with industry, it was agreed that certain amendments, as set out below, to the amending Regulations are appropriate to bring the amending Regulations more in line with the recommendations of Professor Peter Baume contained in his "Report on the Future of Drug Evaluation in Australia", the contents of which were adopted, as a package, by the Government in July 1991. Accordingly the Regulations seek to make the changes described below:

(a)       clarify that the time limit for evaluating applications to include certain drugs in the Australian Register of Therapeutic Goods (ARTG), or certain applications to vary information relating to such drugs where they have already been included in the ARTG, should commence from the day on which the Secretary notifies the applicant that the application has been accepted for evaluation, and not, as could be the case, from the time the applicant pays the evaluation fees;

(b)       one of the conditions presently required to be met by an applicant seeking to qualify for a shorter evaluation period is that the evaluation reports to be submitted by the applicant must have been prepared within a period to be specified by the Minister. This requirement will now be removed, as it is not a condition recommended by Professor Baume in his Report;

(c)       clarify that the reference to "another report" in subparagraph 16C(5)(b)(iii) is to another report of a kind described in the definition of "evaluation report". This is to enable an applicant to submit evaluation reports prepared by a regulatory authority that has drawn upon information contained in a common expert report originating from the manufacturers; and

(d)       insert a new Regulation 16G to provide for a shorter evaluation period of 175 working days for applications to register drugs that are deemed to be new products only because of a change in the packaging or labelling of a drug that is already included in the ARTG, or a change in the directions for use for that drug, and such a change does not, in the Secretary's opinion, require any evaluation of clinical, preclinical or bio-equivalence data.

Subregulation 2.1 amends regulation 16C of the Therapeutic Goods Regulations ("the Regulations") to clarify that the time limits set out under that Regulation do not apply to applications described in proposed new Regulation 16G.

Subregulation 2.2 amends regulation 16C to provide that the time limit is to start when the applicant is notified that the applicant's application has been accepted for evaluation, and not when the applicant pays the evaluation fees.

Subregulation 2.3 - one of the conditions that an applicant must meet before qualifying for a shorter evaluation period is that the applicant's evaluation reports, prepared by an overseas regulatory authority and required to be made available to the Secretary, must have been prepared within a period determined by the Minister. The Minister's power to stipulate any period has been removed by this subregulation, as it is not a condition recommended by Professor Baume in his Report. Consistent with this amendment, subregulation 2.5 removes references to the "relevant period".

Subregulation 2.4 clarifies that the reference to "another report" in subparagraph 16C(5)(b)(iii) is to another report of a kind described in the definition of "evaluation report". This is to enable an applicant to submit evaluation reports prepared by a regulatory authority which has relied upon information contained in a common expert report originating from the applicant.

Regulation 3 duplicates the amendments referred to in subregulations 2.2 to 2.4, so that the same changes will apply to applications to vary information in relation to drugs contained in the ARTG, being applications that are not required to be supported by clinical, pre-clinical or bio-equivalence data.

Regulation 4 inserts a new regulation 16G to provide for a shorter evaluation period of 45 working days for applications to register drugs that are deemed to be new products only because of a change in the packaging or name of a drug that is already included in the ARTG in relation to that applicant, or a change in the directions for use for that drug, or to certain changes to the formulation of that drug, and none of these changes require, in the secretary's opinion, any evaluation of clinical, pre-clinical or bio-equivalence data.


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