Approach: The Cuban Regulatory Strategy Approach: The Cuban Regulatory Strategy. Where biopharmaceutical innovation intersects the administration of regulation and control Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba

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

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

¨OBSERVER MEMBER of ICH¨ 2019 2008 2016 Accepted as an ¨OBSERVER MEMBER of ICH¨ 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

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

Cuban Biopharmaceutical Industry Strategic concertation Towards a perfect balance BioCubaFarma CECMED Cuban National Regulatory Authority Novel biopharmaceutical products patented worldwide Research & development projects On-going global clinical trials (innovative molecules). Scientific projects Scientific knowledge

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

RELIANCE AND COOPERATION Inspection / Audit Quality control Inspection reports from foreign sites from reliable sources Quality Control Testing: Reports of tests from reliable sources RELIANCE AND COOPERATION Review Surveillance Scientific review and supervision Surveillance of local and global data Exchange of GMP reports Registration recognition Source: Samvel Azatyan, CIRS Workshop, Singapore March 2019

CECMED Innovation Office 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;

Agreements between regulatory 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 Technical Exchange and Joint Inspections. Cooperation Agreement with Federal Service for Surveillance in Healthcare

Approach: The Cuban Regulatory Strategy Approach: The Cuban Regulatory Strategy. Where biopharmaceutical innovation intersects the administration of regulation and control Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba