Takahashi Haruo
Yakushigaku Zasshi. 2016;51(1):29-39.
The present Pharmaceutical Affairs Law (PAL) was promulgated in October 1960 and enforced in February 1961．Thereafter, PAL has been frequently revised, was renamed the Pharmaceuticals and Medical Devices Act (PMD Act) in November 2013, and the PMD Act was enforced in November 2014. It describes the change of reference to Post-Marketing Surveillance (PMS) based on the sequence of revisions of PAL for approximately 50 years. Although the purpose of PAL in 1960 was “to control and regulate drugs, quasi-drugs, cosmetics and medical devices (drugs, etc.), and to contrive proper use,” it did not include rules regarding PMS. Thereafter, “to assure the quality, efficacy and safety of drugs, etc.,” “to promote research and development of orphan drugs, etc.” and “to regulate designated substances” were added to the purpose of PAL over a period of time. At the time of establishing the PMD Act, “to assure the quality, efficacy and safety of regenerative products, to promote their research and development, and to prevent the onset and spread of hazards to public health and hygiene through the use of drugs, etc. ”was added to the purpose. Simultaneously, the matters of control and regulation using PAL were increased whenever PAL was revised. Additionally, the PMS systems, such as adverse drug reactions reporting, drug reevaluation and drug reexamination, and the Good Post-Marketing Surveillance Practice (GPMSP) regarding the enforcement standards of PMS, etc. were initiated by regulatory directions and legislated after their establishment. Moreover, an infection reporting system and early-phase pharmcovigilance, etc. were added to the PMS systems. Furthermore, GPMSP was divided into the Good Vigilance Practice (GVP) for marketing license conditions and the Good Post-Marketing Study Practice (GPSP) for enforcement standards regarding post-marketing investigations and clinical trials, and both are regulated.
现行《药事法》于1960年10月颁布，1961年2月实施。此后，《药事法》多次修订，2013年11月更名为《药品和医疗器械法》（PMD Act），并于2014年11月实施。本文基于《药事法》约50年的修订历程，阐述了上市后监测（PMS）相关规定的变化。1960年《药事法》的目的是“对药品、准药品、化妆品及医疗器械（药品等）进行控制和规范，并促进合理使用”，但未包含有关PMS的规定。此后，在一段时间内，《药事法》的目的中陆续增加了“确保药品等的质量、疗效和安全性”“促进孤儿药等的研发”以及“规范指定物质”等内容。在制定《药品和医疗器械法》时，又在目的中增加了“确保再生产品的质量、疗效和安全性，促进其研发，并防止因使用药品等对公众健康和卫生造成危害的发生和传播”。同时，随着《药事法》的每次修订，其控制和规范的事项也不断增加。此外，通过监管指令启动了药品不良反应报告、药品再评价和药品复验等PMS系统以及关于PMS实施标准的良好上市后监测规范（GPMSP），并在确立后进行了立法。此外，PMS系统中还增加了感染报告系统和早期药物警戒等内容。此外，GPMSP被分为针对上市许可条件的良好警戒规范（GVP）和针对上市后调查及临床试验实施标准的良好上市后研究规范（GPSP），两者均受到监管。
