Strengthening the Mexico's Regulatory System of Medicines and Vaccines (EU4Health) <p class="ql-align-justify">The European Union (EU) ¿Latin America and the Caribbean (LAC) partnership on health resilience and vaccine production, proposed in June 2022 by Commission President Ursula von der Leyen with the support of the Prime Minister of Spain Pedro Sanchez, is the response to the high interest manifested by LAC leaders in underpinning their health systems and boosting local manufacturing capacities. The partnership intends to sustain ongoing regional efforts, notably the Plan for self-sufficiency in health matters, endorsed by the Community of Latin American and Caribbean States) in September 2021, which sets out lines of action to strengthen capacities to produce and distribute vaccines and medicines in the region. As discussed at the EU-LAC leaders meeting in December 2021, diversification of global pharmaceutical production is essential for global health security and the EU is keen to contribute to the LAC success of pharmaceutical, biotech and med-tech industries in an ecosystem conducive to ensuring equitable access to quality products. Against this background, the Action presented in the current document intends to help strengthening capacities to produce and distribute high quality vaccines and medicines in the sub - region to ensure the diversification of global pharmaceutical production, improve global health security, the access for quality medicine for all and promote the success of pharmaceutical, biotech and med-tech LAC based industries. This approach supports the ECLAC engagement to enhance sanitary self-sufficiency and promote cross-national health emergency coordination in preparing for and responding to future health crises and challenges, based on the lessons learnt from COVID-19.The areas of interventions of this specific Action are relating to sanitary regulatory frameworks in Mexico, with positive spill overs in Central America. The Action will support capacity building of the Federal Commission for the Protection against Sanitary Risks in Mexico (Comisión Federal para la Protección contra Riesgos Sanitarios - Cofepris) to strengthen its regulatory mandate,update its Global Benchmarking Tools (GBT) in order to upscale its ranking in the list of WHO Listed Authorities framework ¿ WLA, and play a pivotal role at sub ¿regional level&nbsp;and for cross-national coordination for health regulation, harmonisation, security, and resilience. This will also include the strengthening of regulatory system governance and stewardship, and encourage regulatory systems to contribute to the development and manufacture of health technologies, promoting an environment of predictability and regulatory oversight for locally manufactured products. This will, in turn, allow the sub - region to reinforce and maintain their all-hazard preparedness and response capacities, in particular with reference to medicine and other health technologies regulation and harmonisation and guarantee quality-assured, effective, and safe vaccines, medicines and medical devices. The EU will also support, through its regional Team Europe Initiative,&nbsp;the ECLAC sanitary plan aiming at improving resilience, security surveillance and coordination of LAC answer to health challenges and emergency crisis. Through a bilateral approach, benefiting mainly Mexico involving also&nbsp;Central America and EU countries, the Action will be implemented by the <em>Pan American Health Organization</em> (PAHO) office in Mexico. On top of its focus on regulatory framework and regional harmonisation, the Action will also offer the opportunity to undertake high level and technical dialogues on areas of interest between the EU, EU Member States and Mexico competent authorities for medicine regulation and strengthen relations and links.</p><p class="ql-align-justify"><br></p>