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Mutual Recognition of Inspections between EU and US Authorities

Posted on January 22, 2018 at 9:35 AM
The European Union (EU) authorities and the Food and Drug Administration (FDA) signed the mutual recognition agreement (MRA) in February 2017, which enters into force on 01 November, 2017. The agreement is an annex to the EU-US MRA, which was signed in 1998 but is not yet implemented. This MRA will allow EU and US regulators to rely on each other GMP inspections and share inspection outcomes. Additionally, after transition phase, it will waive any requirements for importation batch release testing of products on entry into their territories. The aim of this MRA is to make better use of inspection capacity and reduce duplication. Update: In June 2017, the European Commission confirmed that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. In October 2017, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom). Imported products still need to be batch tested until the FDA recognizes all EU member states' authorities for human pharmaceuticals. Products covered are human chemical pharmaceuticals, medicinal gases, human biologicals - including immunological and bio therapeutics - human radiopharmaceuticals, homeopathic medicines if classified as medicinal products, vitamins, minerals and herbal medicines if classified as medicinal products, active pharmaceutical ingredients and intermediate products and bulk pharmaceuticals. Products excluded are human blood and plasma, human tissue and organs, veterinary immunological and advanced therapy medicinal products. References: (1) http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/general/general_content_000276.jsp&mid=WC0b01ac058005fa12 (2) https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm

Categories: Current Regulatory Trends

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