The development of quality assurance within the Medicines Control Agency
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The development of quality assurance procedures and programmes within the Medicines Control Agency (MCA) in the UK since its creation in 1989 is outlined. A description is given of the quality control processes and procedures that include audits, external accreditation, peer review by the Advisory Committees and, more recently, a concordance review. The importance of quality assurance in the new European procedure is discussed, emphasising the importance of the respective roles played by the rapporteur and the corapporteur in the Centralised procedure, along with that of the Reference Member State and the Concerned Member State in the Mutual Recognition system.
Key wordsquality assurance audit medicines regulation accreditation
This paper is modified from a presentation given at the 10th anniversary meeting of the Medicines Control Agency in July 1999. The review reflects the major contribution made by a very large number of the agency staff and its Advisory Committees to this important subject.
- 2.Improving the regulatory review process. Edited by N McAuslane & S Walker. Kluwer Academic Press (1997).Google Scholar