IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17


Inside this issue


EU-US mutual recognition of inspections "a testimony to trust"

A mutual recognition agreement between the EU and the US to recognise inspections of drug manufacturing sites conducted in their respective territories came into effect on 1 November.

The new agreement – which updates an earlier agreement from 1998 – allows for recognition of inspection outcomes in the respective territories, and hence more efficient use of inspection expertise and resources, and takes the MRA into its operational phase.

THE FDA has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements, namely: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK. The remaining inspectorates will continue to be assessed until 15 July 2019.

“We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,” explained Professor Guido Rasi, Executive Director of the European Medicines Agency (EMA).

“I am very pleased that we can now add the mutual recognition agreement with the FDA to our six existing agreements with third-country authorities,” he added. Currently, EMA has MRAs in place with Switzerland, Australia, New Zealand and Japan, as well as Canada and Israel (with some exclusions).

The EMA notes that around 40% of finished medicines marketed in the EU come from overseas, while 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.




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