As a result of Cuba's interest in the manufacture of biotechnology-derived medicinal products, a group of institutions have been established within the country to provide the technical expertise and support necessary to assure their development. The main centre deals with research, development, and production, while others provide support services and a network for the conduct of preclinical studies and clinical trials.
Eighty-five per cent of biotechnology-derived products on Cuba's domestic market are locally manufactured by the state industry which operates with support from the Center for Genetic Engineering and Biotechnology (CIGB), the Center for Molecular Immunology (CIM) and the Finlay Institute.
The Cuban drug regulatory authority, CECMED, which was created in 1989, is responsible for assuring the quality, safety and efficacy of medicines, including biotechnology-derived medicinal products. CECMED applies national guidelines which have been developed for local industry and cover GMP, GMP for biologicals, GLP, GCP, Good practices for blood banks, and general principles to be followed for process validation. In addition, CECMED provides the following services:
• Inspection of manufacturers;
• Assessment of documentation for registration variations and renewal;
• Issuance of licence certificates for pharmaceutical products; and
• Batch to batch release (documentation, analytical tests or assessment of summarized protocol of batch). CECMED issues the batch release certificates.
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