Future perspectives of regulations — internal market by 1992?
In the interests of public health, the European Community has progressively established common scientific criteria for the evaluation of human and veterinary medicines and harmonized the national authorization procedures. One major consequence of this has been that neither the tests and trials carried out in order to obtain authorization nor batch controls need be repeated within the European Community.
The pharmaceutical industry may benefit from two types of procedures intended to facilitate the registration of their medicinal products in the Member States. One, reserved for biotechnology/high technology medicinal products, involves community concertation prior to any national decision together with special protection against copies for ten years, irrespective of the position under patent law. The other enables firms to request the recognition by the other Member States of an authorization previously granted by one Member State. The experience gained from these two procedures will lead to the choice of the most appropriate European registration procedure for the next decade, which will be the subject of a proposal before the end of 1989.
In order to ensure a favourable regulatory environment for this industry and to promote pharmaceutical research and development in Europe, the Commission has, in its White Paper on the completion of the internal market, proposed several initiatives in the pharmaceutical sector. A better protection of testing data has already been granted to high-tech products and could be followed by further steps to protect pharmaceutical research. A better transparency of national drug pricing and reimbursement systems should be achieved by 1990.
KeywordsMember State Medicinal Product Marketing Authorization European Pharmacopoeia Pharmaceutical Sector
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