Background on Armida Zúñiga Estrada and Her Role
Armida Zúñiga Estrada serves as the Federal Commissioner of Cofepris, Mexico’s regulatory body responsible for overseeing health risks. Her recent announcements highlight significant progress in streamlining the approval process for clinical research protocols, aiming to make Mexico more competitive and attract greater investment in this field.
Progress Made by Cofepris
Reduced Response Times: Zúñiga Estrada mentioned that Cofepris has already achieved a 60% reduction in response times for clinical study approvals. Previously, the average approval time was 115 days at the start of 2024; now, it has been cut down to an average of 40 days.
Digital System and Streamlined Processes: These improvements are attributed to a new digital system, enhanced internal processes, and simplified paperwork. Cofepris has also benefited from the collaboration of regulatory stakeholders and healthcare ecosystem participants.
Addressing Backlog
Cofepris has made significant strides in reducing the backlog of pending protocols and amendments. In just eight weeks, they reduced this backlog by 43%. Out of 578 pending applications, 250 have already been resolved. Currently, there are 328 protocols still pending, and Cofepris aims to resolve them by June 30.
Amendment Response Times: Although Cofepris is now responding within legal timeframes for amendments, Zúñiga Estrada emphasized that they still have the opportunity to further shorten these response times, which will be announced for the first time this week.
International Collaboration and Transparency
Zúñiga Estrada emphasized the importance of international collaboration and transparency in regulatory processes. She highlighted the publication of equivalence agreements (reliance) in the Diario Oficial de la Federación (DOF), allowing recognition of phase three investigation protocols approved by high-standard regulatory agencies, including those acknowledged by the World Health Organization (WHO).
Cofepris plans to publish additional regulatory agreements, such as health registries, medications, and medical devices, in the near future.
Cofepris’ Role in Mexico’s Health Transformation
Zúñiga Estrada underscored that these advancements align with the Mexico Plan, which aims to position Mexico as a clinical research powerhouse. The plan also focuses on strengthening national production, promoting domestic medication and medical device manufacturing, and transforming the healthcare system.
Key Questions and Answers
- What is Cofepris? Cofepris is Mexico’s Federal Commission for Protection against Health Risks, responsible for overseeing health risks and regulating related activities.
- What recent progress has Cofepris made? Cofepris has reduced clinical study approval times by 60%, implemented a new digital system, and streamlined processes to cut backlog. They have also published equivalence agreements in the DOF.
- What is the goal of these advancements? The aim is to make Mexico more competitive in clinical research, attract greater investment, and position the country as a leader in healthcare transformation.
