Fujian introduced a pilot drug marketing authorization holder implementation plan according to the relevant program of the State Council, Fujian province in June this year to November 4, 2018 to carry out pilot work of drug marketing license holders, become the one of the first batch of 10 pilot. In order to work smoothly, the 16 day, the introduction of the "Fujian provincial food and Drug Administration of Fujian province to carry out the pilot work of drug marketing authorization holder system implementation plan", specific operation points, stipulated that all drug production enterprises seriously violate the relevant provisions of GMP records, shall not accept the production enterprises commissioned the production of three years holder. Pilot drug marketing authorization holder system, in order to expand the drug Declaration on the scope of the subject, promote enterprise independent research and development of new drugs enthusiasm, curb drug production enterprises producing chemicals. Fujian Province issued the "implementation plan", in addition to emphasizing the applicant or the holder is the main responsibility of drug safety, motivate comprehensive assessment of drug production conditions, the holder of the level of quality management and market reputation and other factors to determine the selection of the production enterprises, guide the applicant entrusts integrity and good management level of high quality enterprises. It is reported that Fujian province will take the lead in Xiamen port biomedicine, Fuzhou and Sanming pharmaceutical industry to carry out the pilot exploration zone and holder of Zherong Haixi medicine city, encourage high-quality pharmaceutical enterprises in the province and outside the pharmaceutical enterprises and cooperation, the establishment of technology platforms commissioned the production process, and gradually realize the professional division of labor and productivity advantage agglomeration pattern. (reporter Chu Baishan) (Fujian daily)

福建出台药品上市许可持有人试点工作实施方案根据国务院相关方案,福建省于今年6月起至2018年11月4日开展药品上市许可持有人试点工作,成为全国首批10个试点之一。为了工作顺利推进,16日,福建省食品药品监督管理局出台《福建省开展药品上市许可持有人制度试点工作实施方案》,明确具体操作要点,规定凡有严重违反GMP相关规定记录的药品生产企业,三年内不得作为受托生产企业接受持有人委托生产。试点药品上市许可持有人制度,是为了扩大药品上市申报主体范围,提升企业自主研发新药积极性,遏制药品生产企业重复生产药剂。福建省出台的《实施方案》,除了强调申请人或持有人是药品安全责任主体之外,更鼓励持有人综合评估药品生产条件能力、质量管理水平和市场信誉等因素遴选确定受托生产企业,引导申请人委托诚信度好、管理水平高的优质企业。据悉,福建省将率先在厦门生物医药港、福州、三明医药产业集中区和柘荣海西药城开展持有人试点探索,鼓励省内优质制药企业与省内外制药企业合作,建立委托生产加工的技术平台,逐步实现专业分工精细、优势产能集聚的格局。(记者储白珊)(福建日报)相关的主题文章: