News about GMP/cGMP

02.03.2018

EU/US: MRA on Inspections – Four More Member States Added

On 1 March 2018, the FDA listed four additional recognised authorities under Article 7 of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs). This confirms the capability of the following four European Member States to carry out GMP inspections at a level equivalent to the US:

Greece, National Organisation for Medicines
Hungary, National Institute of Pharmacy and Nutrition
The Czech Republic, State Institute for Drug Control
Romania, National Medicines Agency.

The US FDA now relies on their inspections instead of conducting own inspections. EMA notes that plans are on track for the MRA to be operational in all Members States by 15. July 2019.
On 1 November 2017, the FDA already confirmed the capability of the eight EU Member States Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom (as reported).

According to the US FDA, this is another unprecedented step towards more efficient global pharmaceutical manufacturing inspections.

The EMA has also updated the corresponding Q&A document which now contains 10 questions that more or less summarise the current state of the MRA on inspections.