Remirez Diadelis
National Centre for State Quality Control of Drugs, Cuba
Title: Regulatory framework in Cuba
Biography
Biography: Remirez Diadelis
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.