1. 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

2. 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

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

4. ¨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 y 2015
2010 y 2017
Regulatory Authority
of Reference for the Americas
Competent Authority for Registration of Vaccines

5. 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

6. 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

7. 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

8. 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

9. 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;

10. 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

11. 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