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: : The value of being healthy : : |
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Regulatory Framework The vaccine industry is highly regulated. Vaccine development is a complex and time-consuming process. On average it takes 12 to 15 years to develop a new vaccine. Before a new vaccine is approved for release on the market, a stringent regulatory procedure to assess quality, efficacy and safety must be undertaken. In Europe the legal framework for the registration of pharmaceutical products is established by the European Union. Registration of pharmaceutical products can be by a Centralised Procedure, a Mutual Recognition Procedure, or a National Procedure. Assessment of products by the Centralised Procedure is undertaken by the European Medicines Agency (EMEA). This procedure is obligatory for certain products. A marketing authorization, issued by the European Commission, is valid throughout the EU. The EMEA is also responsible for establishing guidelines on quality, safety and efficacy. When a marketing authorization is obtained, each batch of vaccines must still be assessed for quality before release for use. These test are conducted by Official Medicines Control Laboratories (OMCLs). The activities of the OMCLs are coordinated by the European Pharmacopoeia Secretariat, the European Directorate for Quality of Medicines (EDQM) which also has the responsibility for developing binding vaccine monographs to ensure appropriate quality control and quality assurance for pharmaceutical products. In addition, all vaccines and pharmaceuticals are monitored after release onto the market for rare adverse events that may not have been apparent during the clinical trials development programmes. This surveillance function will be strengthened at European level with the establishment of the European Centre for Disease Prevention and Control (ECDC). For additional information see the website of the ECDC. The following are links to some European regulatory authorities:
© EFPIA / EVM 2002-2004 |
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