November 28, 2023: The USFDA has officially pulled out of its membership of the Global Harmonization Working Party (GHWP), an organization currently chaired by China for the standardization of medical devices, due to a divergence of views.
“When FDA became a member of GHWP in December 2021, we did not realize how divergent the two organizations, GHWP and the International Medical Device Regulators Forum, had become and the major challenges that needed to be overcome for them to successfully work together,” according to an FDA statement.
The GHMP did not have a leadership that “is diverse,” or a representative of a global perspective in the Steering Committee, Technical Committee and Strategic Advisory Board.
There is an imbalance of regulator and industry participation in working groups which has often resulted in work items that do not represent the regulator’s perspective, Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health was quoted in the statement.
Lack of transparency
The GHWP also showed a lack of an alignment-based approach and transparency with processes and procedures in the creation, review, and finalization of documents.
“The organization’s past and recent practices of duplicating and modifying documents from other bodies led to inconsistencies and undermining efforts to truly promote global harmonization and convergence for medical devices.”
The GHWP was to study and recommend ways to harmonize global medical device regulations and to work in coordination with the International Medical Device Regulators Forum, APEC and other related global organizations.
It aims to establish harmonized requirements, procedures and standards for the medical device industry. The Working Party is a group of experts from the medical device regulatory authorities and the medical device industry.
The membership of the GHWP has expanded from Asia to the Middle East, North and South Americas as well as Africa, now covering 32 countries and regions. The population of the countries and regions involved accounts for more than half of the global total, with nearly 80% of members being located along the Belt and Road.
In his letter to Jinghe Xu, Deputy Commissioner National Medical Products Administration, FDA’s Dr Shuren wrote that he was “increasingly concerned with the divergent harmonization efforts for medical devices and how some of these efforts do not align with FDA’s priorities or international best practices.”
“When FDA became a member of GHWP in December 2021, we did not realize how divergent the two organizations, GHWP and the International Medical Device Regulators Forum (IMDRF), had become and the major challenges that needed to be overcome for them to successfully work together,” he said in the statement.
“Unfortunately, GHWP does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.”
The FDA will spend the next few months refocusing its efforts and repositioning staff and resources to work on IMDRF.
Invitation from USFDA
FDA’s efforts to advance global harmonization “have been and will continue to be primarily through IMDRF.”
Early next year, the US will assume the chair of IMDRF and the FDA has invited GHWP to discuss ways to ensure alignment of medical device international harmonization efforts.
The US drug regulatory body will continue IMDRF’s efforts to work collaboratively with as many entities as possible, including GHWP, the World Health Organization, the Pan American Health Organization, and the African Medical Devices Forum.