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Since 2003, the EMA and the US FDA have had confidential agreements in place in order to allow for the exchange of confidential information for regulatory and scientific purposes. As part of this arrangement there is also a Mutual Recognition Agreement (MRA) in relation to GMP inspections. The agreements cover a range of topics including information relating to scientific advice, submission procedures, variations, pharmacovigilance, orphan designation and paediatric development.
Back in March 2017, the two agencies signed an agreement in relation to GMP inspections, which includes a transition phase running until July 2019. The aim of this arrangement is to further encourage greater international harmonisation as well as to make better use of inspection capacity and reduce duplication. To further aid this process, the EMA and FDA signed an agreement in August 2017 to allow the FDA to share full inspection reports as well as trade secret information with EU regulators. This allows the two agencies to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk. The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the US FDA have been auditing and assessing the respective supervisory systems since May 2014.
This is not a new approach by the EMA. In fact, they already have well established MRAs with Australia, Canada, Japan, New Zealand, and Switzerland. The main advantages for companies of the existence of the MRA is around GMP certification and batch release. The EMA has just updated the list of agreed countries that the FDA will acknowledge as having equivalent GMP expertise and equivalency. To date the following countries are now within the list: Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Hungary, Romania, Ireland, Lithuania and Portugal. Further territories will be added once evaluated by the FDA. Until all territories are added (by July 2019), import testing will still be a requirement. The agreement covers a broad range of human medicines, as well as biological and veterinary medicines with specific exclusions for human blood, plasma, tissues and organs, as well as for veterinary immunologicals.
For any company planning an EU MA submission for a medicinal product with a manufacturing site in the US, a Certificate of Pharmaceutical Products (CPP) should be submitted. These export certificates are valid for 2 years once issued and conform to the format recommended by the World Health Organization’s (WHO) Certificate of Pharmaceutical Product scheme. The US exporter should apply to FDA for the Export Certificate, and the EU marketing authorisation applicant or holder should ensure that a certificate is submitted for all US sites listed in the relevant EU submission.
The regulatory world is getting smaller and here at ELC Group we can help you take advantage of these key developments, with robust regulatory intelligence and strategy.