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The Change of Reference to Post-Marketing Surveillance Based on the Sequence of Revising the Pharmaceutical Affairs Law.

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.