Regulatory framework in Cuba

6^th International Conference and Exhibtion on Pharmaceutical Regulatory Affairs and IPR

September 29-30, 2016 Orlando, USA

Diadelis Remirez Figueredo

National Centre of the State Quality Control of Drugs & Medical Devices, Cuba

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Cuba is an island located in the Caribbean Sea, with a health policy totally free for the citizenship. Cuba has 857 essential drugs in the Drug Basic Framework and more than 50% is manufactured in the country. These products are mostly generic drugs. On the other side Cuba has important production of therapeutic vaccines and other biological products. Taking into account the previous information, is very important the quality control, safety and efficacy of the drugs and this is the main mission of the Cuban Regulatory Agency (CECMED, picture included). This work will describe the functions, scope and structure of the regulatory agency as well as the main results gotten. CECMED is a reference regulatory agency in Latin America. The main regulations related with the registration of the drugs will be shown. Another important aspect is; how to carry out Clinical trials in Cuba, the certification process of clinical sites in Cuba. The main challenges for regulation will be analyzed. In conclusion, Drug Regulatory Authorities should ensure the quality, safety and efficacy of medicines.

Biography :

Email: diade.remirez@infomed.sld.cu