United States and Switzerland Sign Pharmaceutical Good Manufacturing Practice Agreement

The United States and Switzerland signed the U.S. Switzerland Pharmaceutical Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA) on January 12, 2023.

Signers that took part in the ceremony included 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 Helena Budliger Artieda, and Swissmedic Head of Management Services and International Affairs Dr. Jörg Schläpfer. 

“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

Monitoring the supply chains for pharmaceutical products has become more difficult given the complexities of foreign production and sourcing. The 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 accentuated the need for global regulatory collaboration, including such approaches as MRAs. 

The MRA will allow U.S. and Swiss authorities to share documents from their routine GMP inspections of pharmaceutical manufacturing facilities, which then reduces unnecessary costs and duplicative efforts. This improved efficiency will allow the two authorities to better exercise their respective regulatory discretion to re-allocate resources to where they are most needed, which will ensure 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.

View the text of the MRA.

Crane Trade Services can assist you with questions regarding this matter.  For assistance please contact CWTSConsulting@craneww.com.