EU–Mexico High-Level Dialogue on Health

October 27, 2026

EU and Mexico Launch High-Level Dialogue on Health: Implications for Life Sciences Companies

On 14 October 2026, the European Union (EU) and Mexico held the first meeting of their High-Level Dialogue on Health (the Dialogue). For industry, three outcomes stand out: (i) planned cooperation between the European Medicines Agency (EMA) and Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS); (ii) a push for regulatory reliance; and (iii) joint work to diversify supply chains for critical medicines.

Van Bael & Bellis in Brussels, Belgium and Arochi & Lindner in Mexico work together on life sciences regulatory matters that span the EU and Mexico. This alert summarises the agreed outcomes and highlights potential risks and opportunities for industry stakeholders.

What happened

Mexico’s Secretary of Health, Dr. David Kershenobich, and EU Commissioner for Health and Animal Welfare, Olivér Várhelyi, co-chaired the meeting in Mexico City. COFEPRIS Federal Commissioner Dr. Víctor Hugo Borja attended, together with representatives of Mexico’s Ministry of Foreign Affairs and its Ministry of Science, Humanities, Technology and Innovation.

The Dialogue was launched at the 8th EU–Mexico Summit on 22 May 2026. At that Summit the parties signed the EU-Mexico Modernised Global Agreement and Interim Trade Agreement, which frame this health cooperation.

During the same visit, Commissioner Várhelyi met Mexico’s Secretary of Agriculture, Columba Jazmín López Gutiérrez, and the Director-General of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA), Javier Calderón Elizalde, on sanitary and phytosanitary cooperation. He also met European pharmaceutical companies and gave a keynote speech at the Innovation Week of AMIIF, Mexico’s association of research-based pharmaceutical companies.

Key outcomes

Most outcomes remain commitments to explore initiatives or establish frameworks, rather than binding measures. In the near term, the regulatory and supply-chain pillars are the most relevant to industry stakeholders.

What it means for companies

The Dialogue sets policy direction, not rules, giving industry actors an opportunity to plan ahead and make their views heard.

• Marketing authorisations. An EMA–COFEPRIS working arrangement and greater regulatory reliance could change how EU regulatory work is used in Mexican procedures. Companies with EU-authorised products should assess current COFEPRIS pathways for their Mexican pipeline and monitor the negotiations.
• Manufacturing and API sourcing. Supply-chain cooperation, Plan México and Global Gateway point to investment in production capacity. EU companies diversifying their sourcing and Mexican manufacturers seeking to supply the EU should assess regulatory, GMP and trade requirements in both markets early on.
• Critical medicines. Mexico could be a candidate for a strategic partnership in application of the EU Critical Medicines Act, once adopted, as its draft text provides for partnerships with third countries to diversify EU sourcing of critical medicinal products, APIs and key inputs to strengthen EU supply security. Suppliers of critical medicines, APIs and inputs should monitor any proposals for such a partnership.
• Health data and digital health. References to health data governance and the European Health Data Space point to future dialogue on data use in both regions. Digital health and data-driven businesses should monitor initiatives to align approaches.
• Food and agri-food. Parallel sanitary and phytosanitary talks are relevant to companies exporting food and agricultural products between the EU and Mexico.

How we can help

Our firms work as one team, providing coordinated advice on health projects spanning the EU and Mexico.

• Van Bael & Bellis (Brussels, Belgium): full range of services in the EU and Belgian life sciences field, including advice on competition matters, regulatory, marketing and advertising, intellectual property, and EU trade and customs. As co-founder of the Life Sciences Practice Group (LSPG), an informal and non-exclusive EU-focused network of independent law firms specialised in life sciences which cover most EU jurisdictions, Van Bael & Bellis is able to offer pan-European specialist advice.
• Arochi & Lindner (Mexico): health regulatory work before COFEPRIS, including marketing authorisations, sanitary permits, inspections and import requirements; advertising and consumer protection; intellectual property and regulatory data protection; and corporate and transactional support for investments in Mexico.
• Together: coordinated regulatory strategies for products filed in both regions; structuring supply-chain and manufacturing projects between the EU and Mexico; monitoring the Dialogue and the EMA–COFEPRIS arrangement; and support in engaging with authorities and industry bodies.

Contacts

This alert is for general information only and does not constitute legal advice. It reflects public information available as of [date].

Sources

• European Commission, Commissioner Várhelyi in Mexico to strengthen cooperation on health and discuss food safety (MEX/26/2159).

• European Commission, DG SANTE eNews, “Mexico and the EU kick off High-Level Dialogue on Health to advance common health priorities”, 14 October 2026.