The Pharmaceutical Journal
Vol 270 No 7253 p828
14 June 2003

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Letters to the Editor

Good clinical practice

New legislation

From Mr J. J. Gilroy, MRPharmS

Dr Robin Harman is to be commended for his detailed review, "The concept and implementation of good clinical practice in trials" (PJ, 10 May, p653). It is unfortunate that there is no mention of the European Union directive on clinical trials (2001/20/EC), part of which refers to good clinical practice (GCP). Also there is no mention of the consequent draft Statutory Instrument (SI) which transposes the provisions of the directive into United Kingdom legislation which takes effect from 1 May 2004. The period for consultation of the draft SI closed on 16 May. In addition, of note in this draft is the fact that a National Health Service trust is to be regarded as a sponsor and that there is to be a new UK Ethics Committee Authority responsible for the establishment and monitoring of ethics committees. This authority is in addition to the existing Central Office for Research Ethics Committees.

Dr Harman also refers to manufacturing and packaging of the investigated product but does not refer to labelling. This is an issue with which pharmacy clinical trial personnel not infrequently experience difficulty because there is no requirement of the regulatory authority to approve the label as it would for marketed products. Annex 13 to the Guide to Good Manufacturing Practice states what should appear on the label but not its clarity. None the less, Dr Harman's article is a useful review of the subject of GCP.

J. J. Gilroy
Chairman,
Pharmacy Subcommittee,
Institute of Clinical Research

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