European Medicines Evaluation Agency Scientific Committees

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). ... 

The consequences for the scientific assessment of study validity did induce the European Medicines Evaluation Agency and its Committee for Proprietary Medicinal Products (EMEA/CPMP) to issue a draft guideline to deal with this problem of control sample contamination (CPMP, 2004). In this draft guideline reference is made to the GLP Principles and their requirement of fully, and truthfully, representing all results from a study, and the guideline stresses what is required for a GLP-compliant study report as follows The contamination of control samples with the test compound in toxicology studies shall be reported appropriately within a GLP statement as a deviation or violation. Contamination of controls should also be clearly acknowledged in the study reports and discussed by the Study Director with respect to its impact on the validity ofthe study. ... 

In the Centralised Procedure a Rapporteur and a Co-Rapporteur, appointed from within the member states of EU, have to evaluate the product and report to the European Medicines Agency within 210 days. If the UK is selected as Rapporteur or Co-Rapporteur, the evaluation of the medicinal product is carried out by the MHRA. Occasionally, when there is particular interest in a novel medicinal product, or when a new medicinal product would have a significant affect on drug usage in the NHS, the MHRA will get involved and opinions will be sought from scientific advisory committees. A recent example of this was when the first inhaled formulation of human insulin was licensed. 

Mutual Recognition. The European Medicines Agency (still abbreviated as EMEA, based on its previous name) oversees the process by co-ordinating evaluation of scientific evidence conducted by representatives from all member states convened in the Committee for Human Use Medical Products (CHMP). 

The European Union (EU) ageneies responsible for the scientific evaluation of the safety of feed additives and veterinary medicinal products are, respectively, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). The EFSA is advised on scientific aspects of feed additives, including the safety of target species, consumers, users and the environment, by the Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP). Some of the older evaluations of feed additive uses of coccidiostats under Directive 70/524/EEC were performed by the Scientific Committee on Animal Nutrition (SCAN), which reported to the European Commission prior to the establishment of EFSA. The Committee for Medicinal Products for Veterinary Use (CVMP) advises the EMA on scientific aspects of veterinary medicines. The distinction between medicinal and feed additive uses is not always clear, as some uses to prevent coccidiosis are considered to be medicinal e.g. use of lasalocid in poultry). 

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