REGULATORY
MHLW Lays Out Compliance Guidelines for Manufacturers; Introduction Planned in August 2021 under Amended PMD Law
The Ministry of Health, Labor and Welfare (MHLW) has presented draft compliance guidelines for drug and medical devices makers, which will be introduced in August next year under the amended Pharmaceuticals and Medical Devices (PMD) Law as it will require…
To read the full story
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





