Strengthened Bilateral Collaboration
HSA and MHLW signed the MOC to formalise cooperation in health product regulation.The agreement underscores a shared commitment to advancing regulatory excellence and benefits both manufacturers and patients.
Core Areas of Cooperation
The MOC, signed by HSA and MHLW’s promotes collaboration in reliance for health products, mutual GMP inspection reliance of pharmaceutical manufacturers, information exchange on cutting ‑ edge technology and participation in international programmes.A key focus is to develop GMP inspection reliance arrangements that allow each regulator to recognise the other’s GMP certificates and inspection outcomes.
Operational Framework
By enabling mutual reliance on GMP inspections, the MOC seeks to streamline regulatory processes and remove duplicative inspections, potentially reducing an average of three inspections per year and improving patient access to medicines by up to six months while maintaining strict safety standards.The agreement also provides a formal mechanism to collaborate across the entire product lifecycle—covering clinical trials, product reviews, registration, manufacturing and post ‑ market oversight—to support innovation in medicines, cell, tissue and gene therapy products and medical devices.
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