The 1968 Medicines Act laid down the terms under which investigations of a new potential medicine could be undertaken in man. The Licensing Authority6 does not have rigid requirements concerning all the data that must be provided before authorisation can be given for a clinical trial
6 The Licensing Authority consists of the responsible Minister(s) and the Medicines Control Agency (MCA) — the executive arm in the Department of Health.
of a new drug. This is left to the judgement of the applicant but in any event will include a detailed clinical trial protocol and supporting experimental animal pharmacology and toxicology
The MCA is advised by independent senior experts, sitting on the Committee on Safety of Medicines (CSM) and its subcommittees, on the suitability of the application. If the opinion is favourable, a Clinical Trial Certificate (CTC) is issued (valid for 2 years, and renewable) and the trial may start. Where clinical trial data on a drug already exist the process can be accelerated by submitting summarised preclinical and human volunteer data on pharmacokinetics and tolerability (the Clinical Trials Exemption or CTX procedure). If the MCA does not object within 35 days, the study may start. One further important aspect of regulation (or rather nonregulation) in the UK is that authorisation to start trials with a potential new medicine in healthy volunteers is not required, although local ethics review committee approval is required. This has provided incentive for novel drug investigation in humans but a European Union Directive, when in force, will remove this freedom and require that all clinical trials, i.e. including Phase 1, receive prior regulatory approval.
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