Committee on Proprietary Medicinal Products CPMP

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 If the application is not withdrawn, then the MS will refer the matter to the EMEA under Article 10 of Council Directive 75/319, which describes the procedure known as arbitration.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. 

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. 

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. 

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 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 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). 

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. 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

The efforts to develop a harmonized system concerning direct safety, efficacy, and quality go back to 1965, when the first harmonized directive was issued [95]. Ten years later, the Committee for Proprietary Medicinal Products (CPMP) was established [96]. In 1989, the International Conference on Flarmonization (ICFI) was founded, and the EMEA began operation on January 1,1995 [97]. The EMEA serves as an advisory board, but is responsible for coordinating the approval, manufacturing, and inspection of medical products between the CPMP and member states regulatory bodies [98]. 

BVA/FrAME/RSPCA/UFAW Working Group of Refinement (1993) Removal of blood from laboratory mammals and birds. Faboratory Animals 27 1-22 Cayen MN (1995) Considerations in the design of toxicokinetic programs. Toxicol Pathol 23(2) 148-157 CPMP Position paper (2004) Committee for proprietary medicinal products (CPMP) Position paper/guideline on the toxicokinetic evaluation of control samples in toxicology studies... 

It was noted in this draft, "The Committee for Proprietary Medicinal Products (CPMP) is keen to have the information on the quinine actinometer formally published and accepted as an internationally recognized standard. 

A major issue in performing virus validation studies is determining which viruses should be used. The Committee for Proprietary Medicinal Products (CPMP) has issued guidelines on the selection of viruses to evaluate in validation studies. Processes must be validated for their capacity to inactivate/remove relevant viruses, or viruses that are known to contaminate plasma or other materials in the production process. If relevant viruses cannot be easily propagated in cell culture or assayed, then validation studies should include specific model viruses with characteristics similar to relevant viruses. If relevant viruses do not represent viruses with... 

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