##  [What is GPSP?](/index%2ephp/what-is-gpsp) 

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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**](javascript:void(0)) **Solutions today** to ensure compliant and efficient GPSP operations in Japan’s evolving regulatory landscape.