The US and Switzerland have agreed to a Mutual Recognition Agreement (MRA) on pharmaceutical Good Manufacturing Practices (GMP).
The US Food and Drug Administration (FDA) and the Swiss Agency for Therapeutic Products (Swissmedic) will be able to utilize each other’s GMP audits of pharmaceutical manufacturing facilities under the terms of the agreement with the Swiss Confederation (Switzerland), eliminating the need for additional inspections.
Swiss-US Mutual Recognition Agreement (MRA)
Andi Lipstein Fristedt, the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, who signed the contract on the agency’s behalf, explained that once the MRA goes into effect, the FDA will frequently be able to rely on the factual conclusions of Swissmedic experts, avoiding the need for additional inspections and enabling the FDA to extend its inspectional reach.
The agreement, according to Interpharma, the organisation for the pharmaceutical industry in Switzerland based on research, will boost the robustness of supply chains and hence enhance the safety of supply.
Standard Operating Procedures for Pharmaceutical Manufacturing
Good Manufacturing Practice (GMP) is the minimal requirement that a pharmaceutical manufacturer’s production procedures must meet, as stated by the European Medicines Agency (EMA). The FDA already has MRAs in place with the UK and the European Union (EU).
The FDA is now able to recognise medication inspections carried out by foreign regulatory bodies that have been found to be capable of carrying out inspections that comply with US standards according to the Food and Drug Administration Safety and Innovation Act, which was passed in 2012.
The US-Switzerland MRA has been subject to lengthy negotiations by the FDA’s Office of Global Policy and Strategy. Swissmedic must ascertain whether the FDA is qualified to carry out inspections that adhere to Swiss standards prior to the MRA going into effect. The FDA must decide whether Swissmedic complies with US regulations in a comparable manner.
The FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs emphasized that MRAs provide a means for the FDA to function more effectively and optimize its capabilities in today’s global pharmaceutical industry.