On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they meet FDA requirements.
Importance of Overseas Inspections
“Some drugs approved in the U.S. are either fully manufactured overseas or made in the U.S. but contain some foreign ingredients.” However, that does not excuse them from the FDA’s regulations. Regardless of where it is manufactured, any and all drugs approved by the FDA for sale in the US must comply with the Agency’s regulations and requirements.
There are various measures that the FDA takes to oversee manufacturing and ensure GMP compliance. One of these is by conducting routine inspections of both domestic and foreign drug manufacturing facilities to ensure compliance with the Agency’s manufacturing standards. These standards ensure that FDA’s the quality and product label requirements are being met.
Big Step Forward for the FDA
As of November 1, 2017, the FDA began recognizing its regulatory counterparts in eight European countries “as capable of conducting inspections of manufacturing facilities that meet FDA requirements.” The regulatory authorities that the Agency has found to be capable include those located in the following countries:
- Austria
- Croatia
- France
- Italy
- Malta
- Spain
- Sweden
- United Kingdom
According to the FDA’s recent statement, “this achievement marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA) that enables U.S. and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.”
In addition, Scott Gottlieb, MD, FDA Commissioner, stated that, “At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck.” Furthermore, Dr. Gottlieb also went on to say that these partnerships will improve efficiency and help achieve public health goals and will allow the Agency to refocus its resources on inspections in higher risk countries.
It will be interesting to see the results of this new collaboration and how the FDA will make use of the additional time and resources that are available without having to conduct inspections in eight countries.
For additional information, view FDA’s full announcement.
Do you manufacture a product in the US or overseas? Want to make sure you are in compliance with all of FDA’s GMP regulations before your official inspection? We can help. To learn more about our GMP auditing services, contact us today.