The Pharmaceutical Journal
Vol 278 No 7438 p154
10 February 2007

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Drug trial processes improved

The Medicines and Healthcare products Regulatory Agency will seek advice from the Commission on Human Medicines and an Expert Advisory Group before approval of trials for high risk “first time in man” (FTIM) drugs, the MHRA has suggested this week.

For FTIM trials of such compounds — those acting (directly or indirectly) via the immune system, with a novel target or a novel mechanism of action, or having a secondary potential effect on the immune system via a mechanism of action which currently is not well characterised — trial sponsors will be requested to supply certain documents to the agency before making a clinical trial authorisation application.