Policy Sessions:
World Trade Organization
Regulatory Cooperation during the COVID-19 Pandemic – June 2, 2021
Objective: The webinar focused on regulatory cooperation and its role in facilitating access to medical technologies, especially in the context of COVID-19. While technical regulations, standards and conformity assessment procedures for health-related products are vital for ensuring safety, efficacy and quality, differences between countries could prevent businesses from engaging in trade and supplying their products to patients in need. International regulatory cooperation can help reduce trade costs, while respecting differences in regulatory objectives. This cooperation may take several forms and depths of engagement.
Experts from governments, international organizations and the private sector discussed the opportunities and challenges posed by regulatory cooperation. They explored this policy area from a diverse range of perspectives and experiences on how to put it into practice.
Recording of the session in English can be accessed here.
Presentation from Dr. Renata Amaral available in English and Spanish.
Engagement with External Stakeholders Session – May 18, 2021 – WHO
WHO Relevant Recent Publications on Good Regulatory Practices, Good Reliance Practices and Post-market Surveillance were introduced by the leaders responsible for their development at the WHO, with the purpose to get the Coalition’s members becoming familiar with them and promote a wider utilization.
Session’s recording is available in English, Portuguese and Spanish.
Presentation on Good regulatory practices for regulatory oversight of medical products and Good reliance practices in regulatory decision-making: high-level principles and recommendations by Marie Valentin is available in English.
Presentation on Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics by Leticia Megias /Anita Sands is available in English.
Links to the documents in English and to non-official translations to Portuguese and Spanish are available as follows:
Good Regulatory Practices:
Good regulatory practices in the regulation of medical products
Buenas prácticas regulatorias en la regulación de productos médicos
Boas práticas regulatórias na regulamentação de produtos médicos
Good Reliance Practices:
Good reliance practices in the regulation of medical products: high level principles and considerations
Buenas prácticas de utilización de decisiones regulatorias de otras jurisdicciones (reliance) en la regulación de productos médicos: Principios y consideraciones de alto nivelBoas práticas de utilização de decisões regulatórias de outras jurisdições (reliance) na regulação de produtos médicos: princípios e considerações de alto nível
Post-market Surveillance:
Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnosticsGuía para la vigilancia postcomercialización y para la vigilancia del mercado de dispositivos médicos, incluyendo diagnóstico in vitro
Guia para vigilância pós- comercialização e vigilância de mercado dos dispositivos médicos, incluindo diagnósticos in vitro
Engagement with External Stakeholders Session – December 1, 2020
COVID-19, Impact, response, recovery; Lessons learned from COVID-19 & The Role of the WTO TBT Agreement & GRPs in support of Medical Device Regulatory Convergence were address by experts at the London School of Hygiene and Tropical Medicine, FDA — LATAM Office, WHO, PAHO, CBDL/ALADDIV, Ministry of Economy of Brazil and The Office of the U.S. Trade Representative.
Agenda, Slides Deck, Webinar Recording
Webinar GRPs in Mexico – November 12, 2020
Good Regulatory Practices in Mexico from the perspective of the Executive (CONAMER, DGN, COFEPRIS), Legislative (Chamber of Deputies) and Judicial (Superior Court of Administrative Justice) Powers, including obligations stated at multilateral agreements (TBT, OECD and USMCA). Materials available in Spanish only.
Agenda, Slides deck, Webinar Recording (Audio only available in Spanish).
The Coalition held a series of educational webinars to provide the policy context for Medical Device Regulatory Convergence. Topics included:
- Medical Device International Benchmarks: WHO, IMDRF, MDSAP
- Good Regulatory Practices (GRP)
- Technical Barriers to Trade (TBT)
- International Standards and Conformity Assessment System
- International Medical Device Standardization
Webinar Session 1 – May 26, 2020
Regulatory Convergence and International Benchmarks: WHO, IMDRF, MDSAP.
Agenda, Slides deck, Webinar Recording.
Webinar Session 2 – June 2, 2020
Global Perspectives: GMTA, MDUFA, 21st Century Cures, APEC MD Initiative, GRPs and International Benchmarks: OECD, IDB, ABD, APEC & Advancing Opportunities from the COVID-19 Pandemic.
Agenda, Slides deck, Webinar Recording.
Webinar Session 3 – June 9, 2020
World Trade Organization and TBT Agreement as GRP, International Standards And Conformity Assessment as GRP, International Standards and SDOs for Medical Technology & National Standard Bodies.
Agenda, Slides deck, Webinar Recording.
This policy series was followed by a webinar session from the U.S. FDA as part of the Coalition Regulator Series.
