Tablets Capsules

TC1018

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12 October 2018 Tablets & Capsules T he FDA Safety and Innovation Act was passed by con- gress in 2012, and the FDA has been working to imple- ment this act ever since. The act authorizes the FDA to establish mutual recognition agreements (MRAs), which are agreements between two or more countries to recog- nize a specific process or procedure of the other country. A 1998 MRA signed by the US and European Union (US-EU MRA) included a pharmaceutical annex provid- ing for recognition of each other's GMP inspections, but The FDA has established mutual recognition agreements with EU countries to improve efficiency and increase cooperation between the agency and its European counterparts. This article explains how these agreements work and describes other FDA activities for monitoring the US drug product supply chain. Mutual recognition agreements and other FDA activities for monitoring the US drug product supply chain James Evans EAS Consulting Group regulatory compliance

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