Enhancement of Post-Marketing Safety Measures

ENHANCEMENT OF POST-MARKETING SAFETY MEASURES

In this section, the regulations in the 2002 PAL amendment of drug companies are detailed. Since 1971, Japan has adopted a system for the ‘re-examination’ and ‘re-evaluation’ of marketed drugs. The ‘re-examination’ system involves a reassessment of the usefulness of all new drugs after a fixed period of time (6 years for usual products, 10 years for orphan drugs) following the first approval. Unless the results of the ‘re-examination’ indicate that the product has no major problem, the manufacturer (currently, MAH) is no longer allowed to market the product. On the other hand, the quality, efficacy and safety of the approved drug may be subject to ‘re-evaluation’ based on the advancement of medi-cal and pharmaceutical sciences. Since April 1997, the ‘re-examination’ system has been further system-ized where the basic plan of post-marketing studies is required to be submitted at the stage of the approval of the new products. The result of the post-marketing study has been also requested to be included in Peri-odic Safety Update Report (PSUR) in line with the implementation of ICH-E2C guideline (on PSUR) in April 1997. As an additional regulation, Early-Phase Post-marketing Vigilance (EPPV) has been introduced in 2001 that is unique to Japan. According to this regu-lation, the MAHs are required to repeatedly explain the appropriate use of the new drug to health profes-sionals, collect information on serious ADRs through intensive monitoring for spontaneous reports, and keep a record of the vigilance for the first 6 months after launch.

The details for these regulations, including those for the EPPV, were given in the ‘Good Post-Marketing Surveillance Practice’ (GPMSP), first made as a notice in 1994 and then promulgated as a ministerial ordinance in 1997. The GPMSP covered the regula-tions on EPPV, ADR reports and risk communica-tion as well as those on the investigational studies conducted by the drug companies. Following the 2002 PAL amendment, in 2004 the GPMSP was divided into two ministerial ordinances of ‘Good Vigilance Practice’ (GVP) for the regulations of the ADR reports and risk communication, and ‘Good Postmarketing Study Practice’ (GPSP) for the regulations of the investigational studies.