2019 Volume 9 Issue 3 Pages 197-204
In the development of pharmaceuticals and medical devices, utilization of Real World Data has been progressing internationally. Under such circumstances, in Japan, various strategies have been provided, such as the establishment of the “Clinical Innovation Network” aimed for clinical development utilizing registries, issue and enforcement of the revised “Ministerial Ordinance on Good Post-marketing Study Practice for Drugs (GPSP Ordinance), and notification on reexamination applications utilizing the registry, etc. PMDA has also set up new consultation categories from April 2019, to advise appropriateness of development plan utilizing registry data and method of ensuring the data reliability of registry data for approval applications, regarding individual products. This article introduces these new consultation categories.
