RegulatoryOfficial

Infarmed confirms role in ICMRA reliance working group after Seoul summit

🇵🇹 INFARMED · Tue 10 Nov 2026

Portugal's medicines authority says it held four bilateral meetings and discussed AI, new approach methodologies and patient involvement at the ICMRA summit and plenary, held 3–6 November.

Infarmed, the Portuguese medicines authority, took part in the summit and plenary meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) in Seoul, South Korea, from 3 to 6 November. Its president, Rui Santos Ivo, represented Portugal. The authority published its account of the meetings on 10 November.

According to Infarmed, the summit focused on three areas: responsible use of artificial intelligence in regulatory processes, the development and integration of new approach methodologies (NAMs), including alternatives to animal testing, and stronger patient involvement across the medicine lifecycle. The European Union was strongly represented, by the European Commission, the European Medicines Agency and regulators from six other European countries.

The plenary reviewed ICMRA's strategic priorities and the work of its working groups. Topics included reliance between authorities (relying on another regulator's work), digitalisation, AI, and real-world evidence in public health emergencies. Participants also discussed an international compendium of terminology for medicines aimed at small populations, notably in rare diseases, and how ICMRA coordinates with other bodies, including the World Health Organization.

On the sidelines, Infarmed met Brazil's ANVISA, Saudi Arabia's SFDA, the UK's MHRA and Singapore's HSA. With ANVISA and the SFDA it discussed next steps for implementing existing memoranda of understanding. Talks with the MHRA and HSA covered experience of parallel assessment, which links marketing authorisation procedures with health technology assessment for public funding decisions. Infarmed also made contact with regulators from Ukraine, Paraguay, Mexico, Taiwan, Canada, Switzerland, New Zealand and China, and with the WHO.

Infarmed said its participation in ICMRA's reliance working group was confirmed, and that it intends to become more involved in AI and real-world evidence initiatives. The next ICMRA summit will be held in Ottawa, Canada, in 2027. The source describes no new regulatory requirements or decisions.

What it means for your team

  • Infarmed's confirmed seat in ICMRA's reliance working group signals continued Portuguese engagement in work-sharing and trust-based regulatory approaches.
  • Parallel assessment, linking marketing authorisation with HTA for public funding, was discussed with the MHRA and HSA, which market-access teams may want to follow.
  • AI, real-world evidence and NAMs remain on the international regulatory agenda, though the source announces no new rules or timelines.
  • Memoranda of understanding with ANVISA and the SFDA are moving to implementation planning, with no details published yet.

Official source: INFARMED ↗

Article written by VigiEye from the official source (INFARMED). AI-assisted; check the source before acting.

More Regulatory All →