EU-FDA Mutual Recognition Agreement (MRA) has come into force
On November 1, 2017 the Mutual Recognition Agreement (MRA) between the EU and US came into force. It defines the future cooperation between the FDA and EU regulatory authorities and stipulates mutual recognition of audits of pharmaceutical companies. If an EU authority has audited a pharmaceutical company, no further audit by the FDA will take place – and vice versa. Only in exceptional cases will the FDA carry out audits in Europe or the EU in the USA.
But the scope of the MRA is limited.
- It only applies to a subsection of the pharmaceutical industry (see the illustration below). A joint committee is currently discussing the inclusion of further topics.
- At present, eight EU regulatory authorities have been recognized: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. The FDA will continue performing audits in all other countries of the EU.
- While the FDA recognizes audit reports, it does not issue the GMP certificates that are customary in the EU.
- There are no plans for a joint audit report database.
What does this mean in concrete terms?
Nothing will change until the FDA recognizes all EU authorities. Only when all EU authorities have been recognized as equal will the changes come into force. These changes will eliminate the duties specified in Article 51 Paragraph 1 of Directive 2001/83/EC and Article 55 Paragraph 1 of Directive 2001/82/EC for the Qualified Person (QP) as per the following provisions:
- The test was carried out in the USA
- The batch was produced in the USA
- The batch certificate confirms Market Authorization Compliance for the EU
- Batch release by the QP in case of USA products for the EU market
The documents specified above must be available for each individual batch.
Mastering new challenges
The uncertainty about the recognition of the remaining EU authorities and, in turn, the implementation of the MRA constitutes one of the greatest challenges at present.
There are many additional unresolved issues, e.g. the questions of which certificates can be issued to companies. Overall, controls of goods imported from the US are likely to intensify, as the changes implemented by the MRA could open up new opportunities for the production of falsified medicines.
Two measures are necessary to prepare for 2019: keeping an eye on new decisions by the joint committee and responding to these decisions rapidly. As a result of the MRA, documents for US batch release might have to be re-evaluated and adapted by the QP. It is important to verify at an early stage whether the changes are covered in the existing production and sales records.
We have around 20 compliance experts, all of whom are thoroughly familiar with the implications of the MRA. They will manage the challenges it raises, from verifying your documents to implementing necessary changes.
Graphic: Products that are not covered at present can be included by 2022 if the joint committee decides so.