Zdrowie i gospodarka · 25/11/1997

International Conference on Harmonisation; Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

The Food and Drug Administration (FDA) is publishing a draft guidance entitled ``Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides guidance on the selection of test procedures and the setting and justification of acceptance criteria for new chemical drug substances and new drug products produced from them. The draft guidance is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products.