US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama, the agreement will allow US and EU regulators to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical and active pharmaceutical ingredient manufacturing facilities. In addition to reducing duplicative drug inspections and lowering costs, the deal, which will take effect in November, will enable regulators to devote more resources to other parts of the world where there may be greater risk.

“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, the US Food and Drug Administration’s (FDA) associate commissioner for global regulatory policy.

FDA will assess each EU member state authority individually and a transition phase will be in placeuntil July 2019. Imported products still need to be batch tested until this requirement is waived after the transition phase.

The generic pharmaceutical industry group, Association for Accessible Medicines (AAM), praised the agreement and a spokesman told Focus: "AAM is pleased to see the FDA streamlining inspections by working more seamlessly with EMA. This level of cooperation will help reduce duplicative inspection processes and take steps to expedite approvals - a development that can enhance patient access to safe, effective and more affordable medicines."

Background

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave FDA authority to enter into mutual recognition agreements for drug inspections conducted by foreign regulatory authorities if FDA determined those authorities are capable of conducting inspections that met US requirements.

Since May 2014, FDA and the European Medicines Agency (EMA) have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections.

FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the inspectorate – the regulatory authority – of another EU country. FDA first observed the audit of Sweden’s inspectorate by auditors from the UK and Norway. Since then, FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.

Currently, EMA has such mutual recognition GMP agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).

European Commission

FDA

Text of the Agreement

Editor's note: Updated on 3/3/17 with more details on the agreement.