Drug Evaluation Committee Collection of Examples of Post-Marketing Database Survey Implementation Plans
Pharmacovigilance Subcommittee
August 2018
The "Ministerial Ordinance Partially Amending the Ministerial Ordinance Concerning Standards for Implementation of Post-Marketing Surveillance and Testing of Pharmaceuticals" (the amended GPSP Ministerial Ordinance) was promulgated in October 2017 and went into effect in April 2018, defining a new post-marketing surveillance framework called "post-marketing database survey" (hereafter, DB survey). However, most companies have no experience in utilizing medical information databases for post-marketing surveillance, and their understanding of what should be included in the implementation plan is not sufficient.
Therefore, the Drug Evaluation Committee's PMS Subcommittee* Task Force 3 in 2016-17 prepared a "Collection of Examples of Post-Marketing Database Survey Implementation Plans" together with the JFDA and other related parties. We hope that this document will help to improve the quality of DB surveys and provide quality information to patients.
- *Renamed the Pharmacovigilance Subcommittee in FY2018.
Collection of Examples of Post-Marketing Database Survey Implementation Plans (2.9MB)