1992. Is there the will for there to be a way?
The European Community must become a fully integrated market by 1992. The differing national requirements for pharmaceutical product registration constituted a barrier, unresolved by the creation of a nonmandatory process of mutual recognition of pharmaceutical licences. Interested parties have been asked to recommend measures to abolish the remaining barriers. The principle sought is that a single authorisation shall afford simultaneous approvals in all member states. Considerable debate has taken place but there is no clear concensus. Recommendations include mandatory mutual recognition, a central FDAlike European Agency and a combination of both. A tripartite solution is recommended. This is a sharing of responsibility between the National Agencies and a central European body. A small European Secretariat would coordinate activities and, using expert consultants, hear and resolve appeals. The National Agencies would share the licence application assessments and the CPMP would be responsible for, among other things, the education standards of Agency personnel.
Currie
W J
WJ
Department of Regulatory Affairs International, MSDRL, Merck & Co., Inc., Rahway, NJ.
D001709:Biotechnology / Q000191:economics*; D005062:European Union; D007880:Legislation, Drug / Q000639:trends*; D010604:Pharmacy / Q000639:trends