Book by 30 June 2026 and get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
All Things come to Those who wait ... Germany approved by MRA EU-USA
Recommendation
20-22 October 2026
Initial and Continuous Professional Training for GMP-Auditors
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
Two weeks ago, we pointed out in our News titled MRA Countdown: 10, 6, 4, 2... that the Mutual Recognition Agreement (MRA) with the USA was on track. The News concluded with the statement that Germany and Slovakia were missing. Meanwhile, things have changed!
Germany has also been recognised since 26 June. Slovakia, whose recognition is expected by the middle of July 2019, is still awaited. Now, what will happen next? The answer is to be found in a Question and Answer document (Q&A) of the EMA updated on 27 June 2019. It explains which countries were recognised when, what has been in force since 1 November 2017, which products are included or excluded, how Combination Products are included and what will happen next. Full recognition of all EU Member States is expected by 15 July. This would be the prerequisite for additional complete testing of a medicinal product imported from the USA to be no longer necessary.
You will find the EMA's updated Question and Answer document on the EU-USA MRA on their website.
Related GMP News
29.05.2026European QP Association Developments January through April 2026
15.04.2026ICH Q9 Training Package updated
01.04.2026New EMA GMP Guidelines in the next three Years
01.04.2026New EMA Guidance: Risk Management for Elemental Impurities in Veterinary Medicinal Products
18.03.2026Sampling in the Focus of the FDA
11.03.2026EU Pharma Package: Final Texts officially published