1 min read

In Japan, GPSP (Good Post-Marketing Study Practice) is a critical regulatory framework designed to ensure the safe and effective use of pharmaceuticals after they enter the market. Governed by the Pharmaceuticals and Medical Devices Act (PMD Act) and enforced by the PMDA (Pharmaceuticals and Medical Devices Agency), GPSP outlines the standards for conducting post-marketing surveillance (PMS), gathering real-world evidence, and monitoring the long-term safety profile of approved drugs.

Unlike GVP (Good Vigilance Practice), which focuses on safety reporting systems, GPSP specifically governs how post-marketing studies must be designed, executed, documented, and reported in Japan. These studies often include:

  • Usage results surveys
  • Special case surveys
  • Long-term safety follow-up surveys
  • Drug use-result (DUR) studies
  • Post-marketing clinical studies, when required

Under GPSP, the sponsor is responsible for ensuring scientific integrity, proper data collection, ethical oversight, and meticulous record-keeping. The guidelines emphasize:

  • Transparent study protocols
  • Quality-controlled data collection
  • Appropriate statistical methods
  • Timely safety updates to PMDA
  • Traceability of all recorded data

GPSP compliance is mandatory for companies holding marketing authorization (MAH/MAH-equivalent) in Japan. Non-compliance may result in regulatory actions, re-evaluation of approval conditions, or penalties.

As Japan strengthens its focus on real-world evidence (RWE) and long-term safety monitoring, GPSP has become more important than ever for global pharmaceutical companies entering or expanding in Japan’s market.

Partner with Freyr Solutions for GPSP & Japan Regulatory Compliance

Freyr’s Japan-focused Regulatory Affairs experts support end-to-end PMS and GPSP compliance, including:

  • GPSP-aligned study design & documentation
  • PMS strategy, planning & protocol development
  • Safety data management & RWE integration
  • PMDA consultation & submission support

Contact Freyr Solutions today to ensure compliant and efficient GPSP operations in Japan’s evolving regulatory landscape.