WASHINGTON – The United States and Switzerland today signed the U.S.-Switzerland Pharmaceutical Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA). Deputy United States Trade Representative Jayme White, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Andi Fristedt, State Secretary for the State Secretariat for Economic Affairs Helene Budliger Artieda, and Swissmedic Head of Management Services and International Affairs Dr. Jörg Schläpfer took part in the signing ceremony.
“This MRA will help streamline the movement of pharmaceutical goods and is a step in the right direction to create a safer, stronger, more reliable supply chain that minimizes drug shortages,” said Ambassador Jayme White.
Background
With supply chains for pharmaceutical products becoming more difficult to monitor given the complexities of foreign production and sourcing, this MRA provides an important policy tool to leverage cooperation with like-minded regulatory and trade authorities to improve oversight of key aspects of the drug supply chain. The COVID-19 pandemic has underscored the need for global regulatory collaboration, including through such approaches as MRAs.
Upon entry into force, this agreement allows U.S. and Swiss authorities to share documents from their routine GMP inspections of pharmaceutical manufacturing facilities, which will reduce unnecessary costs and duplicative efforts. Such efficiencies allow the two authorities to better exercise their respective regulatory discretion to re-allocate resources to where they are most needed, thereby ensuring that all drugs imported into the two countries are as safe as possible.
This MRA includes provisions with regard to:
- covered inspections and products;
- when the regulators intend to accept official GMP documents from the other;
- how the regulators will transmit official GMP documents to one another;
- under what circumstances each regulator expects to request that the other conduct inspections;
- under what circumstances a regulator may suspend the other for purposes of the MRA; and
- the establishment of two different committees to facilitate the effective functioning of the MRA.
