Resumo

HECHAVARRIA-NUNEZ, Yanet et al. Methodology for guidelines development for biopharmaceuticals obtained from transgenic plants in Cuba. Biotecnol Apl [online]. 2009, vol.26, n.2, pp.122-126. ISSN 1027-2852.

Molecular farming is an evolving field in Cuba; therefore, establishing the guidelines guaranteeing the quality, safety and efficacy of biopharmaceutical products is a challenge for the National Regulatory Agency (Center for State Control on the Quality of Drugs; CECMED). The methodology to elaborate guidelines for this type of products was mainly based on the revision of the legal and regulatory international framework, the evaluation of the current and prospective developmental stage of the technology in Cuba and the comparative analysis among the manufacturing process steps of a biotechnological product obtained in traditional expression systems and that derived from transgenic plants. A first draft of the regulatory document was compared to guidance drafts issued by other regulatory agencies (such as FDA and EMEA) and extensively reviewed by CECMED specialists as well as by experts of the local biotech industry. As a result, a regulation project was elaborated, and its applicability tested while the assessment of an application for scientific advisory, related to product obtained by this technology. Finally, the regulation was approved, being applicable for products generated in genetically modified plants. It is also valid for edible vaccines and other compounds which do not constitute active pharmaceutical ingredients.

Palavras-chave : transgenic plants; biopharmaceuticals; guidance; regulatory guidelines; CECMED.

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