Committee on Proprietary Medicinal

Committee on Proprietary Medicinal Products (CPMP) A committee, composed of two people from each EU Member State (see European Union (EU) ), that is responsible for the scientific evaluation and assessment of marketing applications for medicinal products in the EU. The CPMP is the major body involved in the harmonization of pharmaceutical regulations within the EU and receives administrative support from the European Medicines Evaluation Agency. See European Medicines Evaluation Agency (EMEA). ... 

A central EEC registration authority (European Agency for the Evaluation of Medicinal Products) will be established and "shall take up its responsibilities on 1 January 1995 (Council Directive 2309/93 of 22 July 1993). The Committee on Proprietary Medicinal Products, CPMP, which consists of members of the Commission and from the states authorities, plays a central role in the existing and future system. It is assisted by different working parties for specific areas. The CPMP coordinates the procedures, assesses applications and provides "opinion reports" and acts as arbitrator in the case of national discrepancies. However, the opinion reports and decisions of the CPMP are not (yet) binding to the member states. For veterinary products identical rules apply here a CVMP acts as the central body. 

In the event of an MS raising an objection based on a concern for public safety and retaining its view at day 90 of the MRP, the applicant may choose to withdraw the application from that MS. If the application is not withdrawn, then the MS will refer the matter to the EMEA under Article 10 of Council Directive 75/319, which describes the procedure known as arbitration. Arbitration results in a review of the product application or variation, and a Committee on Proprietary Medicinal Products (CPMP) opinion which is translated by the commission into a decision binding on all MS. 

David Lyons has an MD from Trinity College Dublin and an MS in applied physiology. He trained in clinical medicine and was an MRC Research Fellow and Senior Registrar in Respiratory Medicine at Northwick Park Hospital, London, and St. James s Hospital, Dublin. Dr. Lyons joined the National Drugs Advisory Board in 1993 and has been a member of the EMEA s Committee on Proprietary Medicinal Products since 1995. He was Chairman of the Mutual Recognition Facilitation Group during the Irish presidency of the EU. 

Consolidated list of comments of Committee on Proprietary Medicinal Products (CPMP)... 

Directive 75/319 laid down the legal basis for the establishment of the Committee on Proprietary Medicinal Products (CPMP). This met for the first time in November 1976, at which time there were nine member states in the EC. Each member state was represented at the CPMP by its named representative and specified alternate. 

Anon, Applicability of Good Laboratory Practices, Committee on Proprietary Medicinal Products III (3824/92) Rev. 1, item 9,1992. 

In the European Union (EU), the Committee on Proprietary Medicinal Products (CPMP) issued a draft Note for Guidance on Safety Pharmacology Studies in Medicinal Product Development in 1997 [3], but it was not finalized or put in force until the middle of 2001. The U.S. Food and Drug Administration (FDA) promulgated equivalent guidance at the same time, but the exact details of compliance and implementation, as will be seen in this volume, are still being worked out. 

Committee For Proprietary Medicinal Products, Xotes to Applicants for Marketing Authorisations on the Production and Quality Control of Monoclonal... 

The reader may wonder why process validation is included. This is simply a matter of consideration of the content of guidelines issued in the past that relate to development pharmaceutics. The first such pan-European guideline, adopted by the Committee for Proprietary Medicinal Products (CPMP) in 1988, included advice on both development pharmaceutics and process development. Later versions of the guidelines on development pharmaceutics and on process development have addressed these topics separately, but the historical and practical perspectives suggests that both need to be discussed here. 

Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/4654/95). June 1998. 

The European Agency for the Evaluation of Medical Products, Committee for Proprietary Medicinal Products, Note for Guidance on Photosafety Testing, London, 2002... 

Christians U, First MR, Benet LZ (2000) Recommendations for bioequivalence testing of cyclosporine generics revisited. Ther Drug Monit 22 330-335 CPMP (2000) European Medicines Agency. Committee for Proprietary Medicinal Products. Note for guidance on the investigation on bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98.http //www.emea.europa.eu/pdfs/human/qwp/140198en.pdf. Cited 30 Dec 2008... 

EMEA Final Opinion of the Committee for Proprietary Medicinal Products Pursuant to Article 12 of Council Directive 75/319/EEC as Amended for Medicinal products Chlormezanone. www.emea.eu.int/pdfs/human/phv/ EN/037597en.pdfi last accessed on 16th December 2003. 

The Committee for Proprietary Medicinal Products (CPMP) within the European Agency for the Evaluation of Medicinal Products (EMEA) has also issued a Note for Guidance on the pharmacokinetic and clinical evaluation of mod-ified-release oral products, which provides some information on the development and evaluation of an IVTVC (5). 

Lewis JA, Jonsson B, Kreutz G, et al. Placebo-controUed trials and the Declaration of Helsinki Committee on Proprietary and Medicinal Products. Br J Clin Pharmacol 2001 52 223-9. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

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