News about GMP/cGMP

• 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.

Source:

FDA: Mutual Recognition Agreement
EMA: News and Updates