(2002; 166 pages)
Regulating biotechnology products: Cuban experience
Mr Rolando Dominguez, Cuba
CECMED, the Cuban national regulatory authority, comprises five main technical departments, including one that regulates biologicals (e.g. vaccines, biotechnology products, blood derivatives and monoclonal antibodies). The structure of an application for a marketing authorization in Cuba is similar to those in other countries, and the documents required mainly provide chemical and biological information.
In Cuba, there are quite a variety of biological products on the market. All of them are manufactured in local facilities which are subject to GMP inspection every year.
The Center for Genetic Engineering and Biotechnology (CIGB) is the leading centre for biotechnology drugs in Cuba. It manufactures a wide variety of products such as recombinant proteins and vaccines. Another important centre is CIM, which produces monoclonal antibodies, recombinant proteins and anticancer vaccines. Thirdly, the Finlay Institute is the leading institute producing meningococcal, tetanus, leptospirosis and polysaccharide typhoid vaccines.
At present, the current requirements for marketing authorization do not fully address the issue of variations. For this reason, CECMED has been working on a regulation on “Changes to an Approved Application: changes to manufacturing process. Comparability of biologicals”. This regulation is now undergoing final review with the local industry.
The regulation requires the approval of changes in the manufacturing process, control methods, manufacturing facilities and equipment, key personnel or the product itself (e.g. stability), and aims to ascertain the safety and efficacy of the new product.
Positive outcomes expected include more flexibility in the implementation of changes to approved products and a more dynamic regulatory process.