Comprehensive Overview of global Initiatives on Medicine Regulation published

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

The European Medicines Agency (EMA) has published an overview of existing international regulatory initiatives for human medicines, like for example International Council for Harmonisation (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/S), International Pharmaceutical Regulators Forum (IPRF) and International Coalition of Medicines Regulatory Authorities (ICMRA) members.

The report entitled "Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives" also lists the respective international projects and details on the number and scope of global initiatives.

The aim of the mapping exercise is to raise awareness of ongoing international regulatory activities, help establish a basis for a more strategic coordination to avoid duplication of efforts, and identify possible gaps.

In the conclusion, EMA mentions that there is "a myriad of initiatives but no strategic coordination". So these mappings and analyses should "strongly support the need for a global strategy to support cooperation between international medicines regulators, to help avoid an overlap of activities and make resources available for areas where gaps still exist."