Beyond studies: toward scientifically driven pharmacovigilance

In July 2024, the MHLW issued a partial revision to the “Approach to Developing Implementation Plans for Post-Marketing Surveillance of Pharmaceuticals.” This revision represents a major turning point in the practical conduct of safety surveillance activities. Even prior to the revision, the guidance had already moved away from a study-driven approach and toward the selection of scientifically appropriate safety monitoring activities. The latest revision takes this concept a step further, placing greater emphasis on scientific reasoning in the design of post-marketing safety strategies.

The changes directly affect day-to-day pharmacovigilance practice, including the role of post-marketing surveys and the conditions under which post-marketing database studies may be conducted. At the same time, the revision reflects a more fundamental shift in mindset that is not always immediately apparent from the wording of the guidance a...