In Case You Missed It: US FDA and EU Advance Quality Initiatives with New Agreement
In an effort to leverage resources and maximize quality oversight, the US FDA and the European Union announced a new mutual reliance initiative. It builds upon current relationships with the European Commission, the European Medicines Agency (EMA), the European Parliament and member states of the European Union.
In the US, approximately 40% of finished drug products, and 80% of active pharmaceutical ingredients distributed to patients come from 150 different countries. US inspectors cannot adequately inspect all foreign facilities, many of which are located in countries with a less stringent regulatory climate. This new, as of yet unnamed initiative will build on the work FDA has already been conducting. Some of these earlier (and still ongoing) initiatives include:
- Establishing agreements with 60 foreign regulatory counterparts
- Enforcing the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which focuses partially on FDA’s inspectional activities
- Working to establish a new Office of Pharmaceutical Quality, which aligns all drug quality efforts into one super-office
- And establishing the Generic Drug Applications Initiative (GDAI), a data sharing program which allows regulators to more easily take action against noncompliant facilities.
As part of the new initiative, a team of US FDA employees from the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and the Office of Global Regulatory Operations and Policy will be based in Europe. The initiative will be managed jointly by all three offices. The goal of the program is to increase FDA’s exchange of information with European regulators which is critical in making decisions affecting public health. FDA indicated that more information would be forthcoming in the months ahead.