EU and US align GMP inspections

Today, 1st November 2017, the European Medicines Agency (EMA) issued a press release announcing that the long awaited mutual recognition agreement between the European Union (EU) and the United States (US), to recognise inspections of manufacturing sites for human medicines in their respective territories, came into effect.

This milestone follows confirmation by the EU, in June 2017,  that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU, and today the FDA confirmed the same capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until the end of the transition phase in July 2019.

This mean that, as of 1st November 2017, EU Member states will not duplicate inspections conducted by the FDA. At the same time, it is expected that the FDA will not duplicate inspection conducted by the recognised authorities.

For more information read the press release on the EMA website.