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目前,全国1300多家无菌药品生产企业中,已通过新版《药品生产质量管理规范》,也就是“GMP”认证的仅有两成。国家食药监总局日前表示,12月31日将是“最后期限”。按照新版GMP,血液制品、疫苗、注射剂等无菌药品的生产,应在今年底前达到新版规范要求;5个月后大限将至,国家食药监总局药化司负责人李国庆明确表示,时间表不会动。
At present, among more than 1,300 sterile drug manufacturers nationwide, the new version of “Good Manufacturing Practices for Pharmaceutical Production” has been passed, which is only 20% of the “GMP” certification. State Food and Drug Administration recently said that December 31 will be “deadline ”. In accordance with the new version of GMP, blood products, vaccines, injections and other sterile drug production, should meet the new regulatory requirements before the end of this year; 5 months after the deadline approaching, the State Food and Drug Administration Li Guoqing, head of the Department of Pharmacy made it clear that time Table will not move.