REGULATORY
MHLW Panel OKs 2-Year Extension of Reexamination Period for E Keppra due to Development of Dosage for Children Younger than 4
A key advisory committee of the Ministry of Health, Labor and Welfare (MHLW) on March 3 recommended approval for a two-year extension of the reexamination period for UCB Japan’s anti-epileptic drug E Keppra (levetiracetam) at a meeting on April 20.…
To read the full story
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 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…





