Amendment of Pharmaceuticals and Medical Devices Act in 2025

Recent violations of pharmaceutical quality control regulations and supply shortages have highlighted a need for improved quality control measures and systems to ensure stable pharmaceutical supplies. In response to these issues, an amendment to the Pharmaceuticals and Medical Devices Act (“PMD Act”) was passed by the Diet and enacted into law on 14 May 2025 (“2025 Amendment”). The 2025 Amendment is also intended to promote and expedite commercialization of new pharmaceutical products, give greater flexibility to pharmacies and strengthen local pharmaceutical product development capabilities. This comprehensive amendment is comprised of the following four pillars:

1)　Ensuring the quality and safety of pharmaceutical products, etc.
2)　Strengthening prescription drug, etc. supply stability
3)　Improving infrastructure to support drug research and development
4)　Strengthening the functions of pharmacies