Abstract
As a worldwide operating company, Hoechst makes all efforts to achieve approvals for its new drugs in all countries where marketing is planned as quickly as possible. The clinical development program must therefore be designed and executed in consideration of the internationally accepted medical standard. The requirements also of the most demanding drug regulatory agencies should then be fulfilled with a sufficient number of high-quality studies (core package). Requirements from individual regulatory agencies for additional local studies should be based only on scientific reasons (eg, different ethnic factors).
In the European Community, standards for clinical trials have been established by EEC-directives and guidelines. By applying these criteria to clinical studies carried out for example in some European countries, in our experience, registrations in Europe and a number of countries overseas can be obtained, although with considerable delays in some countries. These studies can also form an essential part of an NDA-application. Additional studies to comply with specific FDA-regulations will be done in the United States and Canada.
The situation in Japan that necessitates a comprehensive clinical development again and in some other countries requesting local studies will be discussed. Proposals to minimize redundancy of studies that is due to local regulatory requirements will be presented.
An intensive discussion between drug regulatory agencies, the industry, and academia is essential to establish the required standards that are accepted worldwide for new types of drugs (eg, nootropic agents).
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