Switzerland and US sign drug inspection agreement

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US.

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

The Swiss-US Mutual Recognition Agreement (MRA)

“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,” shared Andi Lipstein Fristedt, the FDA Deputy Commissioner for Policy, Legislation, and International Affairs, who signed the agreement on behalf of the FDA.

Interpharma, Switzerland’s research-based pharmaceutical industry association stated the agreement “…will strengthen the resilience of supply chains and therefore improve the security of supply.”

Good Manufacturing Practice for pharmaceutical drugs

According to the European Medicines Agency (EMA), Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.

The FDA already has a MRA in place with the European Union (EU) and one with the UK.

The Food and Drug Administration Safety and Innovation Act, enacted in 2012, permitted the FDA to enter into agreements to recognise drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements.

The FDA’s Office of Global Policy and Strategy has been negotiating the US-Switzerland MRA for several years. Before the MRA enters into force, Swissmedic must determine whether the FDA is capable of conducting inspections that meet Swiss requirements. The FDA must make a similar determination with respect to Swissmedic meeting US requirements.

“In today’s global pharmaceutical market, MRAs offer a way for the FDA to work more efficiently and maximise its resources,” added the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs.

Economics and risks of FDA’s Quality management maturity rating programme