CPMP Committee for Proprietary Medicinal

CPMP (Committee for Proprietary Medicinal Products). Result of the Coordinated Review of 1, 1, 1, 2-Tetrafluoro-ethane HFC-134a, 13 July 1994. 

CPMP Committee for Proprietary Medicinal Products CA Competent authority CT clinical trial EEA European Economic Area... 

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 Repeated Dose Toxicity (CPMP/SWP/1042/99). October 2000. 

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... 

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). 

Anon., European Medicines Evaluation Agency, Human Medicines Evaluation Unit, Committee for Proprietary Medicinal Products, Points to Consider The assessment of QT interval prolongation by non-cardiovascular medicinal products, CPMP/986/96, London, December 17, 1997, http //www.emea.eu.int/pdfs/human/swp/098696en.pdf... 

Ten years later, three directives sought to further promote public health and the free movement of medicinal products within the community. Directive 75/318/EEC [2] set analytical, pharmacotoxicological, and clinical standards for testing proprietary medicinal products, Directive 75/319/EEC [3] established the Committee for Proprietary Medicinal Products (CPMP) and its partial mutual recognition procedure, whereas Directive 75/320/EEC [4] established a Pharmaceutical Committee to examine problems in implementing the pharmaceutical directives. 

The principal scientific bodies of the EMEA are the Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP). These committees have two members from each member state as well as from Norway and Iceland which are appointed to give independent scientific advice to the EMEA. 

Committee for Proprietary Medicinal Products. ICH M4. Common Technical Document for the Registration of Pharmaceuticals for Human Use - Organisation CTD, CPMPIICHI2887I99. London CPMP, 1999. 

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... 

The present guidance does not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidelines issued by the Committee for Proprietary Medicinal Products (CPMP), e.g. the note for guidance on monoclonal antibodies and the note for guidance on products of recombinant DNA technology The Rules Governing Medicinal Products in the European Community, Volume III). 

At this stage the guideline or recommendation embodying the scientific consensus leaves the ICH process and becomes the subject of regulatory consultation in the three parts of the world. In the European Union, it Is published as a draft Committee for Proprietary Medicinal Products (CPMP) Guideline, in the United States, it is published as a draft guidance in the Federal Register, and in Japan, it is translated and issued by MHLW, for internal and external consultation. 

Committee for Proprietary Medicinal Products. Position Statement on DNA, CPMP/BWP/382/97. Available at www.eudra.com. 

As if there needed to be more affirmation regarding the inclusion of data on validation in the application, the EMEA issued the Note for Guidance on Process Validation [40] prepared by the Committee for Proprietary Medicinal Products (CPMP). This came into operation in 2001. 

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