Drug evaluation

Editor, The review by Dr G. Vaughan ('The Australian drug regulatory system' Aust Prescr 1995;18:69-71) shows the improvements that have occurred. The Therapeutic Goods Administration, the Australian Drug Evaluation Committee and all associated are to be congratulated. Physicians reading the review might be misled by the evaluation times for new chemical entities quoted. I believe these refer strictly to evaluation rather than the overall time it takes as the clock is stopped once the Therapeutic Goods Administration has asked questions of the company. For example, the latest Industry survey shows an average time of 373 working days (i.e. 522 actual days) for the delegate's decision rather than the 190 days shown in the review. This is regrettable and there is more than one reason for it. However, the bottom line for prescribing physicians is that they need to know how long it takes for drugs to be approved, so overall times will be more relevant to them.

Jeff Adams
Biotechnology Development Manager
Janssen Cilag Pty Ltd
Lane Cove, N.S.W.

Dr G. Vaughan, the author of the article, comments:

Thank you for giving me the opportunity to respond to the letter from Dr Adams about my article. The people and groups involved with drug regulation will appreciate the congratulations given by him.

It is true the evaluation times do refer to the time taken by the Therapeutic Goods Administration (TGA) to carry out its evaluation role. There can be a need, depending on the quality of the application, to seek further information from the applicant company. Naturally the TGA cannot be held responsible for the considerable time taken by companies to respond to some requests.

As indicated above, the need to ask questions is very much related to the quality of the application. If any sponsor believes that the questions are unreasonable, then they can appeal through a Standing Arbitration Committee or the formal appeal processes which were introduced following the Baume report.

The reason why the TGA refers to evaluation time in working days is because the Baume report set standards using this terminology, which was eventually included in the legislation related to evaluation timelines.