TRIPARTITE ACTION TO ATTEMPT INTERNATIONAL HARMONISATION OF INGREDIENT RULES
April 1st, 2010
BY KEITH NUTHALL
AN INTERNATIONAL attempt to closely harmonise rules on the quality assurance of active pharmaceutical ingredient manufacture and distribution is under way. The European Medicines Agency (EMA), the USA's Food & Drug Administration, and Australia's Therapeutic Goods Administration are ironing out differences when implementing the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use's (ICH) 'good manufacturing practice guide for active pharmaceutical ingredients'. An EMA note ...
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