The EU US Mutual Recognition Agreement (MRA) for the mutual recognition of inspections was signed back in 1998 and has been in force and operation since November of 2019. By having GMP compliance for a site enforced by the respective inspection authority, the FDA uses the EU inspection results and EU inspectors use the FDA results.
To date, the following among others have been entirely excluded from the EU US MRA: new pharmaceutical products approved in the USA, human blood, human plasma, human tissue, human organs and immunological veterinary pharmaceutical products.
The EU US MRA applies in particular for pharmaceutical products and active substances. However there are exceptional cases in which the FDA continues conducting inspections in the EU and EU inspectors get involved in the USA. Article 13 of the EU US MRA for example grants all contracting parties the right to suspend the approval of a recognised authority of the other contracting party, subject to certain formalities and objective assessments. US FDA inspections in Europe will therefore continue.
Dr Ralf Aubeck, Principal Consultant at gempex, certified auditor and internationally active in the cGMP world for 30 years, reports in his specialist presentation “US FDA inspection in the EU notwithstanding MRA?” to what extent an affected site can be prepared for an FDA inspection. Who is affected? For what, when and how is utilising the expertise of an experienced GMP consultant sensible? The GMP expert from gempex answers these questions, backed by valuable personal experiences with FDA inspections in Europe.
US FDA inspection in the EU notwithstanding MRA?
Dr Ralf Aubeck, gempex GmbH
29 January 2019 | 5:00 pm | Room 3
dm-Arena, Messe Karlsruhe
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Registration code: SA0PZZFZ (gempex booth D1.2)