Committee for Human Medicinal

European Medicines Agency. Committee for Human Medicinal Products Guideline on the Specification Limits for Residues of Metal Catalysts, http //www.ema.europa.eu/ docs/en GB/document library/Scientific guideline/ 2009/09/WC500003586.pdf (accessed October 2012). 

Committee for Human Medicinal Products (CHMP formerly CPMP)... 

The Committee for Human Medicinal Products (CHMP), Committee for Veterinary Medicinal Products (CVMP) and Committee for Orphan Medicinal Products (COMP) are the major committees run by this agency to ensure the above objectives. Additional support comes from more than 90 Working Parties (e.g., on efficacy, safety, quality, biotechnology, pharmacovigilance, blood and plasma, etc.) as well as ad-hoc Expert Groups (on subjects like pediatric use, bioterrorism, oncology, anti-HIV drugs, etc.) and also approximately 2500 European experts from competent national authorities. 

Committee for proprietary medicine products (CPMP) 434, 1670, 1675 Committee for human medicinal products (CHMP) 1670, 1678 Committee for orphan medicinal products (COMP) 1678-1679... 

EMEA (European Medicines Agency, Committee for Human Medicinal Products). Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications (Draft). 2005. EMEA/CHMP/SWP/169215/ 2005. 

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. 

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... 

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... 

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. 

Committee for Proprietary Medicinal Product. 1997. Replacement of animal studies by in vitro model, CMPC/SWP/728/95. Available at http //www.emea.eu.int/pdfs/human/swp/072895en.pdf, accessed on January 7, 2005. 

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). 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

The current CP application fee is 232,000 Euros for a single strength associated with one pharmaceutical form. Although the fees are high and the Committee on Human Medicinal Products review is extremely thorough, if successful the centralized procedure leads to an authorization that is valid in all European Economic Area countries, and for this reason is attractive to companies that have a presence in only one or a few European countries. 

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. Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products. CPMP/BWP/3088/99. London, 24 April 2001. http //www. emea.eu.int/pdfs/human/bwp/308899en.pdf... 

The principal scientific bodies of the EMEA are the CPMP and the Committee for Veterinary Medicinal Products (CVMP). They are made up of two members from each member state as well as from Norway and Iceland, and are appointed to give independent scientific advice to the EMEA. The EMEA Secretariat comprises four units administration, evaluation of medicines for human use, technical coordination, and evaluation of medicines for veterinary use. 

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