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2007年,为加强药品生产监督管理,进一步规范药品生产秩序,敦促企业提高质量意识,国家食品药品监督管理局决定对血液制品、疫苗生产企业派驻监督员。药监部门在血液制品、疫苗高风险品种生产企业试行派驻监督员制度,是药监部门在监管手段和监管机制上的创新与尝试,是落实科学发展观、提升监管理念的一项具体举措,是对北京市注射剂生产企业责任制的进一步落实。
In 2007, in order to strengthen the supervision and administration of drug production, further regulate the order of drug production and urge enterprises to improve their quality awareness, the SFDA decided to assign supervisors to blood products and vaccine manufacturers. Drug regulatory authorities in the blood products, vaccines production enterprises at high risk trial resident presence supervisor system is the drug regulatory agencies in the regulatory means and regulatory innovation and attempt is to implement the scientific concept of development and enhance the concept of supervision is a concrete measure, It is a further implementation of the responsibility system of injection manufacturer in Beijing.