Mutual Recognition Agreements and Reliance in the Regulation of Medicines

Type: Consensus Study
Topics: Global Health, Public Health, Health Security
Board: Board on Global Health

Activity Description

An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine will review and assess the use of mutual recognition/reliance agreements and informal practices of recognition/reliance, which allow regulators to use information from their counterparts at foreign drug regulatory agencies, in medicines regulation. The analysis should give particular attention to how national medicines regulatory authorities use such agreements and use such informal recognition/reliance practices and will evaluate their effects on public health, use of resources, and essential regulatory competencies. Specifically, the committee will: 

  • Examine the ways mutual recognition/reliance agreements and informal recognition/reliance practices are used (e.g., inspection, enforcement action, registration) including the range, scope, and time covered in the agreements. The report should discuss how all parties protect sensitive information in such arrangements;  
  • Discuss the benefits, risks, and challenges inherent to such agreements and informal practices, including the risks and benefits to public health. The committee should analyze how the agreements affect the efficiency and stringency of the regulatory system. Specific questions to include are whether the agreements and informal practices enable regulatory agencies to improve efficiency or redirect resources, and if so, how, and what are the long-term implications for regulatory expertise as competencies evolve;
  • Identify major challenges and opportunities facing national medicines regulatory authorities when implementing mutual recognition agreements;
  • Identify other regulatory areas that may lend themselves to these types of agreements and informal practices. 



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