Estrategia regulatoria del desarrollo de Quimi-Hib®, vacuna conjugada semisintética contra Haemophilus influenzae tipo b

Introducción: Quimi-Hib®, una vacuna cubana obtenida por síntesis química y única en el mundo, requirió una estrategia regulatoria específica, porque no hay guía con las pautas requeridas para su producción y control. Objetivo: Caracterizar la estrategia regulatoria de la etapa precomercialización de Quimi-Hib® en Cuba. Material y Métodos: Estudio descriptivo-retrospectivo de requisitos para el registro sanitario de la vacuna cubana. Se establecieron siete pasos estratégicos para abarcar los estándares reguladores vigentes y futuros, con base en opiniones de expertos para la adopción de decisiones. El punto de partida fue la guía de la OMS, aplicable a vacunas anti-Hib de origen natural. Resultados: La estrategia regulatoria se desarrolló a partir de las 15 recomendaciones de esta guía, 11 de ellas se extrapolaron a la vacuna cubana y cuatro no, pero se consideraron sus fundamentos para desarrollar cuatro requerimientos aplicables a la vacuna semisintética. Se adicionaron otros seis, tres a solicitud de la Autoridad Reguladora Nacional de Cuba y tres obtenidos de la literatura relevante disponible. Estos 21 requerimientos completan el paquete regulador, resultado de la estrategia desarrollada para esta vacuna y la posterior aprobación de su registro sanitario y comercialización. Conclusiones: La estrategia regulatoria desarrollada en este trabajo permitió definir un conjunto de recomendaciones que suple la carencia de regulaciones internacionales y contribuyó a la obtención segura del registro sanitario de la vacuna Quim-Hib® que podría generalizarse a otras vacunas con características similares.

Introduction: Quimi-Hib®, a Cuban vaccine obtained by chemical synthesis and unique in the world, required its own regulatory strategy because there is no guideline on the requirements for its production and control. Objective: To characterize the regulatory strategy of the pre-launch phase of Quimi-Hib® in Cuba. Material and Methods: Descriptive-retrospective study of the requirements for the approval of the Cuban vaccine. Seven strategic steps were established to cover current and future regulatory standards based on expert advice for decision making. The starting point was the WHO´s guideline, which applies to anti-Hib vaccines of natural origin. Results: The regulatory strategy was developed based on the 15 recommendations of the aforementioned guideline, 11 of which were extrapolated to the Cuban vaccine and four of which were not, but served as the basis for the development of four requirements with similar rationale that apply to the semisynthetic vaccine. Six additional requirements were added, three of which were requested from the Cuba's National Regulatory Authority and three of which were obtained from the available relevant literature. These 21 requirements complete the regulatory package, the result of the strategy developed for this vaccine and the subsequent approval for marketing authorization and commercialization. Conclusions: The regulatory strategy compensates for the lack of specific guidelines for synthetic Haemophilus influenzae type b vaccines and thus contributed to the approval of the first vaccine of this type. The regulatory strategy is flexible because it includes update requirements throughout the vaccine life cycle, and expert consensus was considered in its development.

Research progress of 12-HETE in the inflammation and oxidative stress / 中华危重病急救医学

12-HETE is a metabolite of arachidonic acid (AA). AA is normally present in membrane phospholipids. The exposure to different stimuli can trigger the release of AA through the activity of phospholipase A2 (PLA2) by cells. An important metabolic pathway which utilizes AA as its substrate is 12-Lipoxygenase (12-LOX), resulting in the formation of 12-HETE. 12-HETE plays an important role in many diseases such as cancer, diabetes, hypertension, and participates in the pathogenesis of inflammation and oxidative stress and other pathological processes. Current research shows that it participates in metamorphism and exudation in the process of inflammation. This review is aimed at summarizing its role in inflammation and oxidative stress, with improved understanding of 12-HETE.

Research progress of 12-HETE in the inflammation and oxidative stress / 中华危重病急救医学

12-HETE is a metabolite of arachidonic acid (AA). AA is normally present in membrane phospholipids. The exposure to different stimuli can trigger the release of AA through the activity of phospholipase A2 (PLA2) by cells. An important metabolic pathway which utilizes AA as its substrate is 12-Lipoxygenase (12-LOX), resulting in the formation of 12-HETE. 12-HETE plays an important role in many diseases such as cancer, diabetes, hypertension, and participates in the pathogenesis of inflammation and oxidative stress and other pathological processes.Current research shows that it participates in metamorphism and exudation in the process of inflammation. This review is aimed at summarizing its role in inflammation and oxidative stress, with improved understanding of 12-HETE.

Study on pediatric drug regulatory strategies in Japan / 中国药学杂志

OBJECTIVE: To understand the current status of pediatric drug regulatory strategies and detailed regulatory measures in Japan. METHODS: Pediatric drug regulatory institutions and specific regulatory measures in Janpan were analyzed based literature review. RESULTS: Janpan had unique regulatory strategies and measures on pediatric drugs. CONCLUSION: In accordance with its specific conditions, Janpan has adopted various strategies and measures for regulation and development of pediatric dings.