Drug Evaluation Committee Toward the Study of Establishing a Safety Surveillance Plan in Accordance with the "Study of Establishing a Plan for Conducting Post-Marketing Surveillance, etc. of Pharmaceuticals
Pharmacovigilance Subcommittee
May 2020
Following the enforcement of the revision of the GPSP Ministerial Ordinance in April 2018, the "How to proceed with the study on the formulation of a post-marketing surveillance plan for pharmaceutical products (March 14, 2019, Pharmaceutical Affairs Council of Japan, No. 0314, Pharmaceutical Safety Bureau of Japan, No. 0314-4)" (hereinafter "Decision Tree Document") was issued. The PV Subcommittee Continuing Issues Team 6 (KT-6), in light of the importance of the Decision Tree Document, has decided to publish the document as a part of the KT-6's efforts to promote the development of the PV research and development process. Based on this information, the KT-6 team examined each step, discussed problems in actual operations at companies, and compiled the results into a white book to serve as a reference material that fills in the blanks of the document.
The results of the survey indicated that an environment for monitoring drug safety based on a scientific approach is now in place, with many post-marketing database surveys being planned. However, as a study based on the current situation, it was considered important to continue to deepen discussions while accumulating actual results and experiences, and to work with the regulatory authorities to probabilize the appropriate post-marketing database survey.
We hope that this document will be useful for planning scientifically appropriate, high-quality safety surveillance activities and improving the quality of safety measures at each of our member companies.
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