Medicines Control Agency enforcement

The Medicines Inspectorate of the Medicines Control Agency enforces good manufacturing standards. The UK has been involved in the Pharmaceutical Inspection Convention since its inception and, through the Orange Guide, sets standards that are now reflected in the EU Directives. 

In 1988, the DHSS was split into two departments, the Department of Health (DoH) and the Department of Social Security (DSS). Following the Evans-Cunliffe report, from April 1989, the Medicines Division of the DoH became the Medicines Control Agency (MCA) under a director, and was expected to self-fund its operation from fees commensurate with the services provided. The UK MCA in 1997 had 458 staff, of whom 150 approximately worked in licensing, 130 in post-licensing, including pharmacovigilance, 75 in licensing inspection of manufacture and enforcement, and... 

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