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Letter to the editor
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.
Biotechnology Development Manager
Janssen Cilag Pty Ltd
Lane Cove, N.S.W.