Tripartite attempt to harmonise international ingredient rules
EU, US and Australia addressing differences in implementing ICH good manufacturing practice guide
An international attempt to harmonise rules on the quality assurance of active pharmaceutical ingredient manufacture and distribution is under way.
The European Medicines Agency (EMA), the US FDA 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 ‘good manufacturing practice guide for active pharmaceutical ingredients’.
An EMA note said: ‘Certain differences exist in pre-licensing approaches, inspections and expectations of finished dose form manufacturers that will benefit from further exchange by the regulators.’ However, it noted the three regulators’ approaches were complementary, notably they ‘acknowledge the primary responsibility of finished dose form manufacturers to qualify and audit their…suppliers to assure reliable manufacturing practices and integrity of…supply chains.’
