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The Cuban Regulatory Strategy: Innovating Biopharmaceutical Regulation

Explore the intersection of biopharmaceutical innovation and regulatory control in Cuba's approach. Learn about the National Regulatory Agency, global clinical trials, market surveillance, and more.

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The Cuban Regulatory Strategy: Innovating Biopharmaceutical Regulation

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  1. Approach: The Cuban RegulatoryStrategy.Wherebiopharmaceuticalinnovationintersectstheadministration of regulation and control Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba

  2. The global Biopharmaceutical TSUNAMI Pharmaceutical & Biotech industries: Exponential evolution Global Clinical Trials on demand 40% drugs in research: Biological products Pharmaceutical innovation: 15% cumulativesuccessrate NationalRegulatory Agency Globalization Biopharmaceutical Industry Speed and sophistication NCE´s On- going challenges: Increase technical & scientific skills of NRA´s to respond Industry

  3. Center for State Control of Drugs and Medical Devices (CECMED)

  4. 2019 2016 Accepted as an ¨OBSERVER MEMBER of ICH¨ 2008 • 2014 • Collaborating Center for Health Technology Assessment Quality Management System ISO 9001-2000 y 2015 • 2010 y 2017 • Regulatory Authority • of Reference for the Americas • 2000-2019 • Competent Authority for Registration of Vaccines

  5. BREAKING PREVAILING REGULATORY PARADIGMS BiopharmaIndustry RegulatoryAuthority Biopharma Industry REGISTRATION AND MARKETING AUTHORIZATION RegulatoryAuthority Regulatory Science RegulatoyScience MARKET SURVEILLANCE AND CONTROL PRECLINICAL RESEARCH Regulatory Science RESEARCH AND CLINICAL TRIALS RegulatoryAuthority Biopharma Industry Regulatory Science Regulatory Authority Biopharma Industry Introducing more efficient regulatory channels with the application of Regulatory Sciences

  6. Cuban BiopharmaceuticalIndustry Strategicconcertation Towards a perfect balance BioCubaFarma CECMED Cuban National RegulatoryAuthority • Novel biopharmaceuticalproductspatentedworldwide • Research& developmentprojects • On-going global clinical trials • (innovative molecules). Scientificprojects Scientificknowledge

  7. Challenges facing regulatory agencies and governments Demands so as to increase access: remove barriers, grant accelerated product registration approvals. • Riskbasedapproach • Limitedresources 01 03 05 Need to develop synergies for the effective use of resources: reliance, recognition and information exchange. • Lack of fast and efficient information exchange 02 04

  8. Quality control Inspection / Audit Inspection reports from foreign sites from reliable sources Quality Control Testing: Reports of testsfromreliablesources RELIANCE AND COOPERATION Surveillance Review Scientificreview and supervision Surveillanceof local and global data Exchange of GMP reports Registrationrecognition Source: Samvel Azatyan, CIRS Workshop, Singapore March 2019

  9. CECMED Cuban Innovation Office CECMED Innovation Office First flagship in Latin America and Caribbean Region Main goal: • Play a leading role as a driving force for the national and regional biopharmaceutical innovation; • Novel regulatory initiatives to stimulate innovation to provide the appropriate incentives for research and development to innovation medicines that effectively target real therapeutic needs; • The global regulatory landscape has evolved into a process of regulatory diversifications, due to the urgent needs for more flexible and less costly regulatory requirements;

  10. Agreementsbetweenregulatory agencies Cuba - Rusia MOU with the Scientific Center for Expertise and Medical Supplies of Russia Technical Exchange and Regulatory Technical Committee Cooperation Agreement with between State Institute of Drug and Good Practice TechnicalExchange and JointInspections. Cooperation Agreement with Federal Service for Surveillance in Healthcare

  11. Approach: The Cuban RegulatoryStrategy.Wherebiopharmaceuticalinnovationintersectstheadministration of regulation and control Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba

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