Pharmaceutical Inspections in Europe, US to Get New Framework

The US FDA and the European Union (EU) took an important step forward this week in pharmaceutical manufacturer inspection collaboration, completing an exchange of letters that will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders.

Ultimately, the letters, which will amend the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement, will enable the FDA and EU to "avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk," according to a prepared statement from the FDA.

“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,” Dara Corrigan, FDA’s associate commissioner for global regulatory policy, said in the statement.

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

Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections. The FDA was invited to observe the EU’s Joint Audit Programme, in which 2 EU nations audit the inspectorate — the regulatory authority – of another EU country. The FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.

In a blog written on this topic by Corrigan last December, she noted that collaborations like these "will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally. Indeed, the need to engage globally in different ways is imperative."

Reference

Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union [news release]. Gaithersburg, MD. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm. Accessed March 2, 2017.