European Committee for Proprietary

There are many conspicuous examples of different actions by enantiomeric isomers of the molecules of various drugs. Suffice it to mention thalidomide, which was known as Contergan in Europe and with which many tragedies were connected before it was withdrawn from the market. Since 1992, the United States Food and Drug Administration and the European Committee for Proprietary Medicinal Products have required manufacturers to research and characterize each enantiomorph of a potential drug. ... 

The Agency continued to thrive and play a key role in Europe and also in all the regulatory and scientific activities of the European Committee for Proprietary Medicinal Products (see... 

Assignment of Documentation and Finished Product. Documentation and samples of finished products are sent to the evaluation unity. The evaluator excim-ines the technical file with reference to different current pharmacopoeia, i.e., the European Pharmacopoeia to which commission Tunisia is adherent as an observer, the American Pharmacopoeia, the British Pharmacopoeia and to the documents issued by the International Conference of Harmonization (ICH), to the guidelines of the World Health Organization (WHO), to the decisions taken by the European Committee for Proprietary Medicinal Products (CPMP) and to a set of bibliographic references. 

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. 

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... 

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... 

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. 

European Union (2004), Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2—October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal Products (CVMP), Off. J. Europ. Union, C24/26-C24/19. 

Committee for Proprietary Medicinal Products Guideline on Comparability of Medicinal Products Containing Biotech-nology-derived Proteins as Active Substance. Non-clinical and Clinical Issues. Evaluation of Medicines for Human Use, The European Agency for the Evaluation ofMedicinal Products, London (2003). 

Committee for Proprietary Medicinal Products, Commission of the European Communities, Directorate General III. Industry-Pharmaceuticals 001329. Brussels, Belgium, March 16,1994. 

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Evaluation of Control Samples In Nonclincial Safety Studies Checking for Contamination with the Test Substance. CPMP/SWP/1094/04. 17 March 2005. http //www.emea.europa.eu/pdfs/human/swp/109404en.pdf... 

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Comparability of Medicinal Products Containing Biotechnology-... 

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