J Pharm Pharmacogn Res 3(suppl. 1): S86, 2015
Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015 September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.
OC-74: EVOLUTION, STRENGTHS AND WEAKNESSES IN REGULATION OF NATURAL HERBAL MEDICINE. BASES FOR NEW PRODUCTS
Introduction: Natural and Traditional Medicine (NTM) is in a renovated space nowadays. Objectives: To characterize the development of regulations for the MNT and perform a critical assessment of their impact in terms of support of related products and processes. Methods: It was conducted a descriptive, cross-sectional and retrospective study of regulatory dispositions from 1989 to 2015. The strengths and weaknesses, the shortcomings and opportunities for improvement and limitation for new products regulations were analyzed by means of group analysis techniques like brainstorming and analysis of experts. The results were organized in a SWOT Matrix. Results: The number of compiled provisions amounted to 24, mainly issued for the Center for State Control of Drug, Medical Equipment and Devices (CECMED). It were identified five broad strengths, five weakness, four opportunities for improvement, and four threads. The lack of a systemic approach in regulations was considered a limitation for the development of new NMT products. Among the negative aspects are that regulations for dispensaries should be strengthened, should be enacted, and that implementation of dispositions for herbal products should be encreased. It was found a positive regulatory evolution of products and processes of NMT, and a political decision of their development and support. The relevance of regulatory base oriented to scientific research was also a necessity identified for new NMT products and for validation of indications and safety in some cases. Improvement strategies were proposed. Conclusions: Regulation for NMT in Cuba is progressing and moving forward for ensuring that the health medications such as herbal medicines used in the modes of MNT exhibit quality, safety, efficiency and effectiveness in favor of preserving the right to Cuban health. The space for new products is expending, gaps have been analyzing, and there are strategies for elimination of these fissures on course.
Citation Format: Sánchez C (2015) Evolution, strengths and weaknesses in regulation of natural herbal medicine. Bases for new products. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S86. Abstract nr OC-74.