Pharmacovigilance in Japan took basic shape by the revision of the Pharmaceutical Affairs Law in 1979, which consists of Re-examination, Re-evaluation, and Adverse Drug Reaction Reporting (ADR-Reporting), while Adverse Reaction/Event Reporting is dominant all over the world as a basic pharmacovigilance, and the Good Post-Marketing Surveillance Practice (GPMSP), a guideline for pharmacovigilance, was first introduced in Japan in 1993.
The GPMSP was revised at the end of 2001 to introduce the Early Post-marketing Phase Vigilance (EPPV) for the purpose of not only education for physicians but also acceleration of ADR-Reporting and to abolish the so-called “3, 000 case surveillance”, which is an obligatory observational case surveillance without comparator for new drugs.
Internationally, on the other hand, the ICH guidelines of E2A, E2B, and E2C, which were established for pre-marketing safety management, also greatly contributed to the improvement of post-marketing safety management, and new discussion in the ICH has started on such topics as Periodic Safety Update Report (V1 : PSUR), Good Case Management Practice (V2 : GCMP) and Prospective Plan of Pharmacovigilance (V3 : PPP). The pharmcovigilance system in Japan seems to be changing in the sense of international harmonization as well as for science, although further discussion is needed concerning the post-marketing studies and surveillance.

抄録全体を表示

Good Post-Marketing Surveillance Practice (GPMSP) defines “post-marketing clinical trials” as industry-initiated studies constituting a part of Post-Marketing Surveillance (PMS). Post-marketing clinical studies play the role of gathering further information on appropriate drug use. This is why the proper conduct of medically required post-marketing clinical trials would facilitate the proposal of new treatments with improved efficacy and/or safety over existing therapies, thereby contributing to the promotion of EBM and to the advance of healthcare. In the case of anticancer drugs, in particular, post-marketing clinical trials are of great importance, because they also serve as Phase III studies. In reality, however, pharmaceutical companies are not very active in conducting these studies because of the many issues involved. To solve or alleviate these problems, the Japan Pharmaceutical Manufacturers Association and COTEC are making aggressive efforts.

抄録全体を表示