Part 26 Repeal Shows How FDA Relies on Foreign Drug Inspections

The Food and Drug Administration published a final rule on February 19 revoking 21 CFR Part 26, the regulations that set out how the United States and the European Community would recognise each other's inspection reports for drug factories and certain medical devices. The rule takes effect March 23, 2026. FDA said the regulations had been superseded in part by a 2017 agreement with the European Union and are "outdated, do not reflect current Agency practice, and are unnecessary."

The rule is a repeal of text, not of cooperation, the agency said. Responding to a comment that warned of higher costs and less international collaboration, FDA wrote: "This rule does not revoke an MRA."

What a mutual recognition agreement does

FDA's page on mutual recognition agreements says they allow drug inspectors to rely on information from drug inspections conducted within each other's borders. The page says an MRA avoids duplicate inspections and lets regulators shift resources toward drug manufacturing facilities with potentially higher public health risks around the world. FDA has agreements in force with the European Union, Switzerland and the United Kingdom.

The legal basis is the Food and Drug Administration Safety and Innovation Act of 2012. FDA's page says the law lets the agency enter into agreements to recognise drug inspections by foreign regulators if FDA determines they are capable of conducting inspections that meet US requirements. The final rule describes current MRAs, including the 2017 EU annex, as binding international agreements.

From the 1998 agreement to the 2017 annex

According to the rule, Part 26 was issued after the United States and the European Community signed a mutual recognition agreement in 1998 to make better use of limited inspection resources. It had three subparts: one for pharmaceutical good manufacturing practice inspection reports, one for medical device quality system audits and premarket evaluations by listed conformity assessment bodies, and a framework section for both.

In 2017, the two sides amended the agreement through an exchange of letters, producing the United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices. Under that annex, the rule says, US and EU regulators "are able to utilize each other's GMP inspections of pharmaceutical manufacturing facilities." Its new terms made the drug subpart of Part 26 obsolete, and FDA said the annex has been implemented without regulations that mirror it, as have the later agreements with Switzerland and the United Kingdom.

The device side never took full effect. The rule says the 1998 medical device annex "has never been fully implemented," and that other mechanisms, such as the Medical Device Single Audit Program, now exist for mutual recognition with Europe on device inspections, so that subpart is no longer necessary.

Why repeal now

FDA proposed the repeal in September 2024 and received eight comment submissions, some supporting and some opposing it, before finalising the rule without change. It classified the action as deregulatory under Executive Order 14192 and said the rule imposes no new burdens and is not expected to result in compliance costs.

The agency added that revoking Part 26 "should not be interpreted as FDA retreating from our commitment to working with our foreign counterparts, including through MRAs, to achieve greater efficiencies and increase our inspectional reach."