IPRP - 17th Meeting

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Rio de Janeiro-
Brazil

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The seventeenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on 3–4 June 2026 in Rio de Janeiro, Brazil. A total of 35 IPRP Members and Observers were represented at the meeting. The MC welcomed one new IPRP MC Member: the Drug Regulatory Authority of Pakistan – DRAP, Pakistan. NMPA, China participated in this IPRP MC meeting as an ad hoc Observer. Dr. Asmaa Fouad from EDA, Egypt was re-elected as the IPRP MC Vice-Chair to serve for a two-year term starting at the end of the Rio de Janeiro meeting.

 

The following IPRP Working Groups (WGs) provided reports on their achievements over the past months and their future activities: Identification of Medicinal Products (IDMPWG); Nanomedicines (NWG); Cell & Gene Therapy (CGTWG); Biosimilars (BWG); Bioequivalence for Generics (BEWGG); and Quality (QWG).

The updates included the finalisation and approval by the MC of the QWG report on the analysis of similarities and differences for Quality post-approval changes (PACs)/variations for publication on the IPRP website.

 

The MC also discussed a number of Focus Topics at the meeting. These included:

  • Experiences in the implementation of ICH Guidelines, including discussion of the results of the survey conducted by the IPRP Implementation Small Group, providing an overview of common implementation approaches and challenges among the IPRP Members;

  • Reliance practices and cooperation, with extended discussions on reliance approaches presented by ANVISA, Brazil and NAFDAC, Nigeria. In addition, EC, Europe presented their practical learnings from the EMA-WHO Post-Approval Changes Pilot Programme, with 77 National regulatory authorities (NRAs) participating in one or more pilots by the end of 2025. The MC also discussed the ongoing ICH work on establishing the Digital Collaboration Platform, with work building on ICMRA-led initiatives on post-approval change management and Pharmaceutical Quality Knowledge Management (PQKM). It was noted that work is ongoing to update the IPRP Reliance Repository, which will be finalised and published on the IPRP website after the meeting in Prague in November 2026;

  • Artificial Intelligence (AI), focusing on the use of AI in medicines regulation, with a presentation from MFDS, Republic of Korea on AI-driven transformation of their activities, and MHRA, UK on their AI regulation supporting innovation and growth. In addition, FDA, United States presented their 10 guiding principles for good AI practice in drug development, developed jointly with EMA (EC, Europe).

     

In addition, the MC supported a new model for future meeting organisation to allow more time for in-person discussion, especially of the Focus Topics, which will be implemented from the Prague 2026 meeting. Finally, the MC also received a number of regulatory updates from IPRP Members and Observers.

 

The next meeting of the IPRP MC is planned for 18–19 November 2026 in Prague, Czech Republic.

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