REGULATORY
MHLW OKs First Generics for Tracleer, 6 Other APIs towards December Listing
The Ministry of Health, Labor and Welfare (MHLW) on August 15 approved first generics for seven active pharmaceutical ingredients (APIs) towards their reimbursement listing in December, including those for Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) drug Tracleer (bosentan). Tracleer is…
To read the full story
Related Article
- Talion AG, 2 Other APIs Skip December Gx Listing
December 8, 2016
- First Generics for 5 APIs to Join NHI Price List on Dec. 9
December 8, 2016
- Kipres Generics Might Add Bronchial Asthma Indication before December Listing
October 21, 2016
- Kipres/Singulair to Face Generic Onslaught in Dec.; Competition to Hit Tracleer, Too
August 4, 2016
REGULATORY
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
- Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
- MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
- MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
- MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
March 5, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





