WHO’s Access to Medicines and Health Product Division (WHO/MHP) confirms that, as of 01 January 2020, all activities and functions within the scope of WHO’s Regulation of Medicines and other Health Technologies Unit (WHO/RHT) are now carried out by WHO’s Access to Medicines and Health Products Division (MHP), namely through the Regulation and Prequalification Department. WHO’s MHP division is not a new entity or separate organization, but a restructured office that remains part of WHO. WHO/MHP confirms that WHO/MHP is bound by the commitments originally made by the Quality Assurance and Safety Medicines Unit of the World Health Organization (WHO/QSM) to protect FDA-provided non-public information in accordance with the mutual confidentiality arrangement entered into between WHO/QSM and FDA, effective 11 August 2005 (the “2005 Arrangement”), and that WHO/MHP will continue to protect any non-public information previously shared by FDA with WHO/QSM and/or WHO/RHT in accordance with the provisions of the 2005 Arrangement.  For the avoidance of doubt, FDA shall also continue to treat and protect—in accordance with the provisions of the 2011 Arrangement—any non-public or confidential information that has been or will be provided by WHO/RHT and/or WHO/MHP thereunder. 

As of Quarter 4 of 2013, the Quality Assurance and Safety Medicines Unit of the World Health Organization (WHO/QSM) has ceased to exist, and all its functions and responsibilities have been absorbed by the Regulation of Medicines and other Health Technologies (RHT) Unit. RHT provided a statement committing to implement the 2005 QSM Confidentiality Commitment as written.

FDA – WHO/QSM, Mutual Confidentiality Commitment