The Pharmaceutical Journal
Vol 270 No 7240 p356
15 March 2003

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MLX278 covering letter (PDF 130K)
MLX278 consultation list (PDF 470K)
MLX 287 (PDF 450K)
MLX287 regulatory impact assessment (PDF 280K)
Draft regulations (PDF 600K)
Directive (PDF 155K)

Clinical trials rules consultation

Views are being sought by the Medicines Control Agency on proposals to implement a European Directive on good clinical practice in clinical trials. The Directive has to be implemented by 1 May 2004.

European Union Directive 2001/20/EC includes many practices and criteria which are already found in current clinical trials practice in the United Kingdom. However, it includes significant new controls which will affect all British clinical trials. For example, no clinical trial will be allowed to start unless authorised by both the MCA and an appropriate ethics committee. Currently, most clinical trials in Britain are conducted under exemption schemes that mean that clinical trials certificates are not needed.

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