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REGULATORY
- No Additional Safety Measures Needed at this Time for Xocova: Panel
May 11, 2023
- Label Revisions Ordered for 32 Hypertension Meds to Caution against Fetal Risks
May 10, 2023
- LDP’s Life Science League Submits Proposal; Ex-Minister Urges Price Debate from Industrial Policy Perspective
May 10, 2023
- MHLW Panel OKs 197 More Health Damage Claims for COVID Vaccines
May 10, 2023
- Chuikyo to Go Back Offline from May, but Online Viewing Still Available
May 9, 2023
- FY2023 COVID Booster Program Begins for Elderly, Health Workers
May 9, 2023
- Japan Shoots for 80% Replacement Rate in 60% of All Biosimilar APIs by FY2029
May 8, 2023
- PMDA, NHO Ink Database Deal, Data on 9 Million-Plus People to Be Available
May 8, 2023
- MHLW to Decide on Policy for Real-Time Supply Info System within FY2023: Official
May 8, 2023
- Japan Ends Priority Review for COVID Products with Severity Downgrade
May 8, 2023
- Ferring Japan Faces Biz Improvement Order for GMP Violation at Overseas Site
May 1, 2023
- Japan Approves Mefeego as First Abortion Pill
May 1, 2023
- LDP League Calls for Generic Market Entry Rules to Ensure Supply: Draft Proposal
April 28, 2023
- Outline of Expert Panel Report Calls for New Forum to Discuss Generics’ Future, Revisiting of Spillover Rule
April 28, 2023
- Lawmakers’ League on Pollen Allergy Boosts Up
April 27, 2023
- As Japan Mulls Pushing Back Fee Revisions, Chuikyo Reps Fret Impact on Drug Price Updates
April 27, 2023
- Shionogi CEO Presses Govt for G7 Debate on Pull Incentives for Antibiotics
April 27, 2023
- Mpox Cases Hit 120 in Japan: MHLW
April 27, 2023
- Chuikyo OKs CEA Discussion Timeline for FY2024 Reform; Industry Hearing Set for August, November
April 27, 2023
- Ultomiris Clears Japan Panel Review for NMOSD Approval
April 27, 2023
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Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…
The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…
A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…
Many members of a key reimbursement policy panel on November 10 called on the health ministry to revisit the current listing requirement of at least 25 years for the designation of essential medicines now that annual revisions have been introduced…
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…