ADEC milestone

Dr Stan Goulston, Professor Martin Tattersall, Senator Tambling

"The work of ADEC sets a benchmark for excellence in medical science. The scrutiny of ADEC does not only benefit consumers and manufacturers whose products pass this rigorous evaluation, this scrutiny also benefits Australia's international reputation as an independent source of scientific and medical excellence", said Senator Grant Tambling, Parliamentary Secretary to the Minister for Health and Aged Care.

The anniversary dinner marking the 200th meeting of the Australian Drug Evaluation Committee (ADEC) was held at Sydney University in December 1998.

Since ADEC first met, not only have the number of applications to market new drugs increased substantially but the number of reports of adverse drug reactions has risen from 28 in 1964 to more than 10,000 last year.

"All Australians should feel enormously proud of the work of ADEC which is largely unsung and yet an extraordinary contribution to the health and welfare of all Australians", Senator Tambling told the gathering.

Attendees at the dinner included former ADEC members and three past ADEC Chairmen - Dr Stan Goulston (1974-82), Professor Mervyn Eadie (1985-1993) and Professor Susan Pond (1994-1996).

Dr Goulston spoke of the talks during his period as ADEC Chairman to increase Australian collaboration with overseas evaluation bodies, the close affinity with the UK, and relations with the US Food and Drug Administration and Sweden. He also spoke of the growing workload resulting from the great increase in drug applications and of the system he introduced to deal with this more efficiently.

Current Chairman, Professor Martin Tattersall, spoke of the impact of the 1991 Baume report on the evaluation process and of growing community expectations with regard to health information, treatment options and involvement in medical decisions. He also pointed to the emergence of consumer health movements as a "significant force" in health care.

Supplementary data

As a result of a recommendation made by the 1996 TGA Review, since 5 January 1998 the DSEB has allowed the submission of 'new data' for evaluation addressing issues raised in primary evaluation reports.

These data are more commonly known as supplementary data, and may be either pre clinical (Part 3) or clinical (Part 4). There are two options in submitting supplementary data:

1. Supplementary data may be submitted at the end of the evaluation phase after the last of the evaluation reports has been sent to the sponsor. The sponsor must notify TGA in writing within five working days after the receipt of the last evaluation report of its intention to submit supplementary data.
2. After the sponsor has received a Part 3 or Part 4 evaluation report, the sponsor may notify of its intention in writing to submit and may submit supplementary data, relevant to that Part, during the evaluation process.

There are two components to the supplementary data process:

• the submission of data and payment of evaluation fees within 60 working days;
• the evaluation of the data within a maximum timeframe of 135 working days, not including S31 "clock stop" time. Supplementary data may only be submitted once for each data type.

Supplementary data is not accepted after the pre-ADEC process has commenced (ie after the Delegate's overview and recommendation have been sent to the sponsor).