As a compliance consultant, I have always wondered why the same facility or site is inspected by multiple agencies even though the audit reports from the first inspection has demonstrated compliance.
After years of contemplation, a big step was achieved last month towards this question where U.S. FDA and EU signed a Mutual Recognition Agreement to effectively perform the site inspections and rely on inspection reports of each other. It is important to understand this agreement was established in 2017 where EU has confirmed that US FDA has capabilities to conduct the inspections to that of EU. However, it took around 2 years for FDA to confirm this capability on each EU member states and within the last three months, Luxembourg, Netherlands, Germany and Slovakia have been added into this confirmation list. Let us examine what it means to your drug manufacturing sites and import sites.
No more import testing
Currently, human medicines imported into EU requires an import testing. With this MRA in place, such import testing is no longer required provided each batch / lots manufactured in US has a batch certificate to indicate compliance with marketing requirements. This reduces the cost and process burden associated with import testing for pharmaceutical companies.
No more multiple audits
So far, there were several instances where U.S. FDA and EU will audit a site on the same year even though the site has demonstrated compliance and successfully cleared the first audit. With MRA in place, agencies will rely on each other’s report and will divert their focus on sites that have not been inspected. This means, less audit to the sites and QA / Auditing groups will not have to prepare multiple times!
Not all drug products are included in the scope of MRA at this point. The MRA excludes Veterinary products, Human Vaccines and Plasma-derived products but these are expected to be included within July 2022. If you are supporting such manufacturing or import testing sites, sorry you will have to bear the pain of import testing and repeated audits for another 3 years!