Japan’s recent Upper House election delivered a stinging defeat for the ruling Liberal Democratic Party (LDP) and junior coalition partner…
REGULATORY
Generic Share Fails to Meet FY2012 Target but Reaches 47% in New Calculation Method
The share of generic drugs in Japan was 27.6% on a volume basis, slightly below the target of 30% in FY2012, the health ministry said on December 18. The share was calculated based on the market price survey for September,…
To read the full story
Related Article
- Premium for Innovativeness or Usefulness (I) Set as Prerequisite for 10% “Precursor Premium”
December 20, 2013
- Plan to “Institutionalize” Key Premium Ditched for FY2014 Revision; Status Quo to Remain
December 19, 2013
- Chuikyo Subcommittee Agrees on 60% Rule for First Generic Prices, 70% for Biosimilars
December 19, 2013
- Off-Patent Drugs to Get Continuous Price Cuts Until 60% Generic Share Reached
December 19, 2013
REGULATORY
- Japan Publishes List of 203 Suspected or Confirmed Nitrosamine Impurities in Medicines
August 6, 2025
- MHLW Panel OKs RX-to-OTC Switch of Medicon Cough Suppressant for Children
August 6, 2025
- MHLW Device Review Chief Pledges Evidence-Based Approvals amid Diversifying Technologies
August 6, 2025
- LDP OKs FY2026 Budget Guidelines, Natural Increase Set at 400 Billion Yen
August 5, 2025
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…