The ‘Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice’ will help the country’s two regulatory agencies, the US Food and Drug Administration (FDA) and Swissmedic, become more efficient and expand their international reach.
The agreement, signed by the FDA, Swissmedic, the Office of the US Trade Representative and Switzerland’s State Secretariat for Economic Affairs, will cover facilities making human and veterinary drugs.
The Food and Drug Administration Safety and Innovation Act, enacted in 2012, has allowed the FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements.
An agreement between the US and Switzerland has been in negotiations for several years. The MRA relies on the FDA determining whether Swissmedic is capable of conducting inspections that meet US requirements; and Swissmedic making a similar determination with respect to the FDA meeting Swiss requirements.
“In today’s global pharmaceutical market, MRAs offer a way for the FDA to work more efficiently and maximize its resources,” said Andi Lipstein Fristedt, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, who signed the agreement on behalf of the FDA.
“Once the MRA enters into force, the FDA will be able to rely on the factual findings of Swissmedic experts in many cases, thus avoiding duplicate inspections and allowing the FDA to expand its inspectional reach.”