MEDICC Review: Can you synthesize CECMED's role as a national regulatory authority?Olga Lidia Jacobo: Any medicine, device or equipment-Cuban or imported-used in our health system must be approved by CECMED, the country's single regulatory authority. To ensure new products meet global standards of quality, safety and effi cacy, WHO defi nes the six basic functions for NRAs as: medicine regis-tration; lot-by-lot vaccine release; inspections; clinical trial authorization; laboratory access; and post-marketing surveillance. As a WHO Level 4 NRAr, CECMED undergoes regular, independent evaluations and inspections to certify compliance with standardized best practices throughout each aspect of these six functions. By way of background: after Cuban scientists started producing new vaccines and other biotech products in the1990s, CECMED,
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