Proprietary medicinal products

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

Committee for Proprietary Medicinal Product (1993) Note for Guidance Investigation of Chiral Active Substances III/3501/91. 

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 Europeans, meanwhile, have focused on the need for better care in study design, conduct and interpretation (Spindler et. al., 2000), aiming to incorporate these in the revision of the CPMP (Center for Proprietary Medicinal Products) carcinogenicity guidelines. 

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). 

The Committee for Proprietary Medicinal Products [8] applied the BCS, with certain requirements, to dispense with bioequivalency tests if the active pharmaceutical ingredient is class I and the in vitro dissolution of the finished dosage form is fast [9], An active substance is considered highly soluble if the amount contained in the HDS of an IR product is dissolved in 250 ml of each of three buffers within the range of pH 1-8 at 37°C (e.g., pH 1.0, 4.6, and 6.8). There should be linear and complete absorption, which indicates HP to reduce the possibility of an IR dosage form influencing the bioavailability [8], The similarity of the dissolution profiles of the test and reference products is demonstrated in each of three buffers within the range of pH 1-8 at 37°C (e.g., pH 1.0,4.6, and 6.8). If there is rapid dissolution of the product, where at least 85% of the active substance is dissolved within 15 min, no further comparison of the test and reference is required. Further requirements include that excipients be well established and have no interaction with the pharmacokinetics of the active substance and that the method of manufacture of finished product... 

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... 

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. ... 

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 competent authorities of the Member States shall suspend or revoke an authorisation to place a proprietary medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the proprietary product. 

The proposed review of PLRs was already considered necessary by the United Kingdom but became a requirement when it joined the European Union. It was to correspond to the requirements under Directives 65/65/EEC and 75/318/EEC of the European Community that required that, throughout the Community, proprietary medicinal products granted licences before 22 November 1976 should be reviewed by 20 May 1990. All Member States of the European Community were similarly required to review the quality, safety and efficacy of products on their market. 

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... 

Council Directive 75/318/EEC of 20 May 1975, on the approximation of the laws of Member States relating to analytical, pharmacotoxic-ological and clinical standards and protocols in respect of the testing of proprietary medicinal products. 

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. 

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