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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Members are from industry and regulatory agencies. Provides a forum for a constructive dialog between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan. Identifies areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety. Makes recommendations on practical ways to achieve greater harmonization in the interpretation and applications of technical and requirements for registration. |