- The Food and Drug Administration said Wednesday it will now recognize inspections of drug manufacturing facilities around the world conducted by eight European agencies, aiming to reduce duplicative oversight through greater collaboration with EU member states.
- In what the FDA termed an "unprecedented step," the U.S. agency agreed to rely on GMP inspection data gathered by drug regulators located in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
- "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," said FDA Commissioner Scott Gottlieb
Closer cooperation between the FDA and EU member state regulators reflects the reality that many drug products are manufactured — either wholly or in part — by production sites outside of the U.S. and Europe.
The European Medicines Agency, for example, estimates that 85% of medicines sold in the EU have at least one manufacturing step performed outside of the 28-member economic bloc (soon to be one less with the departure of the U.K.).
Both the FDA and EU regulators regularly inspect manufacturing facilities that supply drug products in order to ensure quality standards are maintained. Now, the FDA can rely on information gathered by inspectors from any one of those eight agencies to determine whether sites are up to code.
Recognition by the FDA reciprocates a similar step taken by the European Commission, which confirmed in June that the U.S. regulatory has the capabilities in place to conduct GMP inspections at a level equivalent to the EU.
"We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity," said Guido Rasi, head of the European Medicines Agency, in a Oct. 31 statement.
Sharing the burden of inspections should help the FDA in its efforts to inspect more foreign manufacturing sites, particularly those in India and China. In recent years, the agency has stepped up its oversight, issuing scores of warning letters to facilities that aren't up to par with accepted GMP standards.
A 1998 agreement between the U.S. and the EU first laid out the prospect of mutually recognizing GMP inspections. However, the annex that would govern such collaboration was never fully implemented until now.
The FDA plans to complete capability assessment of all remaining EU countries by July 2019, laying out the prospect for recognition of additional regulators beyond the eight identified on Oct. 31.