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European Parliament. One of the main functions of the Board is to oversee the activities of the Agency particularly concerning the budget. The Secretariat will provide the technical and administrative support for the Committee for Proprietary Medicinal Products (CPMP). Initially, this staff will be about 100 in 1995. The Secretariat will report to the Executive Director, Fernand Sauer, who was appointed in June 1994 and whose responsibilities encompass day-to-day administration of the Agency, management of the budget, and support of the CPMP. |
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The CPMP is the scientific committee and consists of two members nominated by each Member Statethese members should have experience in the evaluation of medicinal products. This Committee previously existed under the old procedures but was reformed in January 1995. The members may be accompanied by a maximum of three experts at each meeting. The main task of the CPMP is to provide the scientific opinion on the authorization and renewal of medicinal products including pharmacovigilance opinions when emergency measures such as urgent labeling changes or removal of the product from the market are required. The CPMP may also establish working parties and have access to expert groups to support them in execution of the tasks. Various working parties have been formed, i.e., pharmacovigilance, biotechnology, safety, quality, efficacy, and ad hoc groups have been formed on anti-infectives, AIDS, oncology, and blood products. The experts available to the CPMP are proposed by the Member States and must have proven experience in the assessment of medicinal products. Some of the areas where they could support the CPMP are |
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scientific evaluation of medicinal products; |
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transmission of assessment reports, Summaries of Product Characteristics, labels, package leaflets or inserts for those products; |
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coordination between Member States of the supervision of authorized products (particularly pharmacovigilance); |
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coordination between Member States of verification of Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice; and |
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advice to companies on nature and extent of tests and trials during development. |
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The Centralized procedure should offer direct and quick access to the European market for innovative new products. Its use is mandatory for biotechnology |
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