Australian Drug Evaluation Committee

Milestone in drug evaluation - 200th meeting of ADEC

The Australian Drug Evaluation Committee (ADEC), has been an important part of the formal system of drug evaluation that was set up in Australia after the experience of thalidomide. This month, ADEC, whose role has been to act as an independent scientific advisory group to the federal Minister for Health, will hold its 200th meeting. ADEC was established on the 25th July 1963 under the Chairmanship of Dr Edgar Thomson. In 35 years, there have been seven Chairmen including current Chairman, eminent cancer specialist, Professor Martin Tattersall.

Pharmacist, Ms Fay Guy, was Minute Secretary for more than 100 meetings.

ADEC is made up of a small group of core members plus 10-20 associate members. It has had significant input into the development of requirements for clinical trials in a period when these were in their infancy, and the establishment of a formal surveillance scheme of adverse drug reactions.

In 1970, its first subcommittee, the Adverse Drug Reactions Advisory Committee (ADRAC), was established, and this committee took over the responsibility for advising about data on adverse drug reactions. This allowed ADEC to concentrate on assessing data on the risks and benefits of new drugs for which manufacturers and importers have sought approval to market in Australia, advising on product labelling and warnings, and recommending the rejection or removal of drugs from the market as necessary.

Retiring members:

Two Associate Members, Professor David Handelsman (Endocrinology) and Dr Cecile Lander (Neurology) will retire after completing five year terms. Dr Rosemary Ayton (Obstetrics and Gynaecology) will complete two terms of core membership.

European Union guidelines

Following consultation between the Drug safety and evaluation Branch (DSEB), the TGA Laboratories Branch (TGAL) and the Australian Pharmaceutical Manufacturers Association (APMA) it has been decided that the following European Union (EU) Guidelines are to be adopted in Australia. The EU Guidelines are generated by the Committee for Proprietary Medicinal Products/International Conference on Harmonisation (CPMP/ICH) and are to be regarded as part of Volume 1 of the Australian Guidelines for the Registration of Drugs (AGRD) and will be listed in the next edition of the AGRD.

Ref. No. CPMP/ICH/174/95
Note for Guidance on Genotoxicity: a Standard Battery for Genotoxicity Testing of Pharmaceuticals

Ref. No. CPMP/ICH/140/95
Note for Guidance on the Need for Carcinogenicity Studies of Pharmaceuticals

Ref. No. CPMP/ICH/136/95
Note for Guidance on Reproductive Toxicology: Toxicity on Male Fertility

Ref. No. CPMP/ICH/240/95
Note for Guidance on Fixed Combination Medicinal Products

The following document will not be adopted in Australia:

Ref. No. III/5447/94
Guideline on the Assessment Report (AR)

Impurity limits in new BP monographs - reminder!!

As part of an application to register a new chemical entity (NCE), tests and limits for impurities are normally included in specifications for both the active raw material and the finished product. When present in significant amounts, the limits must have been 'qualified' according to European Union guidelines.

If, subsequently, a BP monograph is published on the same NCE and the impurities in the monograph are less stringent than those agreed at the time of registration, the previously agreed tests and limits continue to apply because they were a part of the conditions of registration. It is entirely possible that the BP limits are predicated on a synthetic route different to the one that the registered supplier uses, and consequently that the impurities will be qualitatively and quantitatively different. Unless the sponsor takes action, the product must comply with both the conditions of registration and the applicable official standard. Sponsors will presumably wish to resolve this situation in advance of any TGAL testing, and will in any case need to decide which tests they themselves will conduct prior to release of each batch.

If there is conflict between the tests and expiry limits approved for the purposes of registration and those of the official standard, or uncertainty as to which apply, sponsors should apply to the TGA either to vary the registered specifications or for an exemption from the official standard. Such applications would normally fall into the 'Category 3' type. If the original data did not support the higher level impurities in the monograph, additional toxicological data may be required, in which case the application becomes Category 1.