Objectives and achievements of regulations in West Germany

Abstract

1. Like any other country with a large population of patients and a strong innovative pharmaceutical industry, the Federal Republic of Germany (FRG) is bound by international developments, standards and trends. 2. As a regulatory agency our situation is defined by membership of the European Economic Community (EEC), of the Pharmaceutical Evaluation Report (PER)-system developed by EFTA (European Free Trade Association) and of the OECD (Organization for Economic Co-operation and Development) as well as by strong international industrial connections, for instance, between the USA or Japan with Europe or with the FRG. This implies that applications for marketing for new drugs are seldom supported by data generated in the FRG alone. 3. Concerning basic rules like GMP, GLP and GCP, legal aspects and transparency of procedures harmonization has been achieved in the FRG with regard to EEC requirements (see Notice to Applicants, 1989 of the Committee for Proprietary Medicinal Products (CPMP)). Based on the currently available EEC/CPMP Notes for Guidance, complete harmonization of requirements for the results to be submitted case by case has not been achieved yet; divergent decisions, however, are mostly due to variations in interpretation of the data submitted. 4. Harmonization of decision making is as difficult a task for EEC Member States as for anybody else. To first derive a national decision and then try to harmonize this decision with those taken by others, seems a backwards procedure. Therefore, the development of rules for mutual acceptance or prevailing of national decisions, seem most urgent tasks for the EEC and the FRG.