Sánchez GCA, Rodríguez RJ, Galardi MK, Matech HL

Language: Spanish
References: 13
Page: 1-19
PDF size: 476.72 Kb.

ABSTRACT

Introduction: The Cuban regulatory authority, since the time it joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, has jointly, with the national pharmaceutical industry, developed a program for strengthening regulations with the standards of this organization.
Objective: To diagnose the level of recognition of regulated topics and guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as it is manifested in the national regulations for medicines and, particularly, for biological and biotechnological products.
Methods: Descriptive, longitudinal and retrospective study of the regulations valid in the Center for the State Control of Medicines, Medical Equipment and Devices (140) and the guidelines of the Council for Harmonization (102), on quality, safety, efficacy and multidisciplinary aspects, as they appear published on their websites. The guidelines of the Council for Harmonization were characterized, and the coincidence was quantified with respect to regulated topics, recognized guidelines, and outreach actions of the ongoing diagnosis.
Results: The basic guidelines prior to joining the Council for Harmonisation (Q1A, Q7 and E6 (R1)) were complete. The correspondence with the regulated topics was 79%; with the issues of the Council guidelines regulated in Cuba, 87%; and 59% for recognized guidelines. The specific ones for biotechnological products accounted for 80% in quality, and for 100% in safety. The Group M4 (Common Technical Document) is 100% implemented only for biological products. The limitations for unregulated topics and unrecognized guidelines are currently being studied, as well as for drafts under consultation, questions and answers, and for post-adoption review requirements.
Conclusions: The results obtained permitted to conclude that there is a confirmed satisfactory level of incorporation of the standards of the International Council for Harmonisation, which should promote processes of acceptance, mutual recognition, exchange of information and simplification of procedures with other authorities, in view of timely accessing biotechnological products and other medicines with a guarantee of quality, safety and efficacy in health systems.

REFERENCES

1. Sánchez González CA. El CECMED de Cuba como Observador en el actual Consejo Internacional de Armonización Farmacéutica ICH. Contribución Especial. Anuario Científico Cuba: CECMED 2017 [acceso 02/11/2019];Año 15:7-8. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/anuario/nuevo_anuario_del_cecmed_20 17_0.pdf

2. CECMED. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED); 2019 [actualizada 01/02/2019; acceso 02/02/2019]; Disponible en: https://www.CECMED.cu

3. ICH. International Council of Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH). Ginebra: ICH; 2019 [actualizada 01/02/2019; acceso 02/02/2019]. Disponible en: https://www.ich.org

4. CECMED. Regulación No. 23-2000. “Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos”. La Habana: CECMED; 28 septiembre del 2000.

5. CECMED. Regulación No. 24-2000, “Requerimientos de los estudios de estabilidad para el registro de nuevos ingredientes farmacéuticos activos”. La Habana: CECMED; 28 de septiembre del 2000.

6. CECMED. Regulación No. 25-2000, "Requerimientos de los estudios de estabilidad para el registro de productos biológicos y biotecnológicos". La Habana: CECMED; 28 de septiembre del 2000.

7. CECMED. Regulación No. 61-2012, "Requisitos para el Registro Sanitario de Medicamentos de Uso Humano". La Habana: CECMED; 24 de abril de 2012.

8. Buró Regulatorio para la Protección de la Salud (BRPS). “Buenas Prácticas de Fabricación de Ingredientes Farmacéuticos Activos”. Anexo No. 09 de la Regulación No. 16-2006. La Habana: BPRS; 18 de octubre de 2006.

9. Ministerio de Salud Pública (Minsap). Resolución No. 165-2000, “Directrices sobre las Buenas Prácticas Clínicas en Cuba”. La Habana: Minsap; 4 de octubre del 2000.

10. CECMED. Regulación No. 33-2003, "Cambios al proceso de producción de productos biológicos registrados. Comparación de productos biológicos". La Habana: CECMED; 12 de mayo de 2003.

11. CECMED. Regulación M 83-15, “Requisitos para el registro sanitario de productos biológicos de uso humano”. La Habana: CECMED; 11 de diciembre de 2015.

12. Sánchez C. Reglamentación para medicamentos y diagnosticadores en Cuba, un análisis de 22 años. Anuario Científico del CECMED; 2012 [acceso 30/02/2020];Año 10:13-23. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/anuario/Anuario%202012.pdf

13. Thorsteinsdóttir H, Sáenz T, Quach U, Daar A, Singer P. Cuba-innovation through synergy. Nat Biotechnol Suppl. 2004;22(Suppl):DC19-24. DOI: 10.1038/nbt1204supp- DC19