MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
The United Kingdom’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
Two of the bodies that MHRA will join are the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation (ICH), which are concerned with the harmonization of medicines and medical devices regulations globally. The third body is the Medical Devices Innovation Consortium (MDIC), which is an American public-private partnership aimed at progressing innovation and getting transformational medical technology to people sooner.
“We are delighted to join these three international organizations to collaborate on regulatory alignment that will help deliver safer, innovative, and more cost-effective medicines and medical devices to the people who need them sooner,” said Glenn Wells, chief international and partnerships officer at the MHRA, in a June 16, 2022 press release.
“We are currently building a world-leading regime for regulating medicines and medical devices in the UK that prioritises patient safety while fostering innovation, and we look forward to sharing expertise with partner organisations for the benefit of patients not just in the UK but worldwide.”
Source: MHRA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.