A new agreement has been reached between the US and EU regulators for regulatory inspections. The FDA, the EU Commission and EMA have signed a confidentiality commitment which allows the FDA to share commercially confidential information, including trade secret information relating to inspections with other EU regulators.
According to the EMA, although confidentiality agreements have been in place since 2003, complete disclosure was not possible under these arrangements. This latest agreement means that full inspection reports will be shared between the regulators “allowing regulators 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 EMA stated.
Sharing inspection reports is a huge step forward in facilitating coordination between regulators, reduce repetition and rework and introducing efficiencies within the inspection process. The regulators also anticipate sharing best practices and lessons learned, thus introducing further learning and sharing experiences across the agencies. It has been hailed as a positive move by industry experts such as Dr Joshua Sharfstein, associate dean at the Office of Public Health Practice and Training, the John Hopkins Bloomberg School of Public Health: “This is a terrific step forward to facilitate coordination between regulators and reduce redundancy for companies. There are so many companies that are part of the supply chain that it makes sense for the EMA and FDA to be able to share the workload”. Dr Sharfstein is well versed in the regulatory process as he served as principal deputy commissioner at the FDA from 2009 to 2011.