Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Close this folderRegulating biotechnology products
View the documentComparability of biotechnology products and cell substrates
View the documentAssessing biocomparability: a Canadian perspective
View the documentRegulatory aspects of nucleic acid vaccines
View the documentReport on WHO Monitoring Group on Gene Therapy
View the documentRegulating biotechnology products: Cuban experience
View the documentRegulation of products derived from recombinant DNA technology in China
View the documentRegulation of biotechnology products in the Republic of Korea
View the documentRegulation of biotechnology products in Indonesia
View the documentRecommendations
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

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.

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