Mutual Recognition Agreements 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 agreements, the agreements which allow regulators to rely on 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 the effects agreements have on public health, use of resources, essential regulatory competencies.  Specifically, the committee will:

  •  Examine the ways mutual recognition agreements are used (i.e.: inspection, enforcement action, registration) including the range, scope, and time covered in the agreements. The report should discuss how all parties in such agreements protect sensitive information;  
  • Discuss the benefits, risks, and challenges inherent to such agreements, including the risks and benefits to public health. The committee should analyze how the agreements effect the efficiency and stringency of the regulatory system. Specific questions to include are whether the agreements 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.

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