Drug regulation in the United Kingdom.

The British system under the Medicines Act by which new drug applications are evaluated is described in a step-by-step manner from submission of application to the issuance of a clinical trial certificate by the licensing authority. At the end of a period by clinical trials the submission is brought back for a product license. Once a drug is marketed it falls within the purview of the adverse reaction monitoring group of the Committee on Safety of Medicines (CSM). A recent innovation is "monitored release", by which, for a period of time after marketing, case reports are submitted by the pharmaceutical company to the CSM. The advantages of the British system are: (1) the final licensing decisions being made by the academic members of the Committee means that they are insulated from commercial and political pressures, and are additionally reached without undue delay; (2) academic members are not permitted to be retained as consultants to the industry on a long-term basis; (3) evaluation solely on British studies is not obligatory--foreign studies are also acceptable. Weakness in the system are: (1) recruitment of people experienced in pharmacology and therapeutics is difficult; (2) there is an inordinate work load on the academic members of the Main Committee and Subcommittees. Importance of an effective monitoring in the postmarketing stage is emphasized, because the long-term judgement must necessarily be based on wide experience in the field. The multiplication of the same of similar drugs is deplored, and innovative efforts in the quest for new drugs, especially for rare diseases, are to be encouraged.