EMA updates Website on Mutual Recognition Agreements

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA) including details on the new agreement with the U.S. Food and Drug Administration, FDA. Additionally, the Q&A section has been updated with a new set of questions & answers (July 26th, 2017) regarding the impact of the MRA on marketing authorization applications and relevant variations:

• "How does the EU-USA Mutual Recognition Agreement (MRA) affect marketing authorization applications or variations?"

In the case of manufacturing sites located in the US, Export Certificates (valid for 2 years) should be submitted. The US exporter should apply to FDA for the Export Certificate and the EU marketing authorization applicant or holder should ensure that a certificate is submitted for all US sites listed in the relevant EU submission. Alternatively, if pre-existing EEA GMP certificates are available these can continue to be used (valid for 3 years after the date of the inspection, unless stated otherwise on the certificate). This also applies to variations relating to a change to add such manufacturers.

• "I plan my submission, which includes manufacturing sites for the medicinal product located in the USA, before November 2017, when the Mutual Recognition Agreement is expected to become operational, but the submission will not be approved until after this date. What evidence am I expected to provide on the GMP status of these manufacturers?"

When the EU-USA MRA enters into force EU authorities can formally recognize Export Certificates issued by FDA for manufacturers located in the USA for products within the MRA scope. In the meantime, if no EEA GMP certificate is available, applications will not be invalidated for that reason alone, EMA states. "During the assessment procedure a risk-based decision will be made on a case-by-case basis, taking account of the status of the MRA, whether a pre-authorization inspection is triggered for other reasons and, if so, whether the inspection will be done by an EEA authority or FDA."

For more information, see Questions and answers on impact of EU-USA mutual recognition agreement on marketing authorization applications and relevant variations on the EMA website.