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REGULATORY
- SaMD Could Be Eligible for 2-Stage Approval System: MHLW
June 1, 2023
- Japan Diet Enacts Bill to Create “Japan CDC”
June 1, 2023
- Japan to Quadruple Supplies of Sublingual Hay Fever Therapy in 5 Years
May 31, 2023
- LDP OKs Project Team Proposal to Boost Pharma Innovation, Create Command Tower
May 31, 2023
- LDP Launches Lawmakers’ League on Self-Medication
May 31, 2023
- Japan to Launch New Forum to Spur Secondary Use of Medical Data in Drug Discovery
May 30, 2023
- Japan Trade Minister Demands China Release Detained Astellas Employee
May 30, 2023
- MOF Panel Flags Japan’s High Drug Cost per Capita, Stays Pat on Cost-Effectiveness-Based Reimbursement, Copay Review
May 30, 2023
- Cancer Meds from Servier, Taiho, Pfizer’s AA Drug Clear Review for June Approval
May 30, 2023
- PM Advisors Make Irregular Call for Properly Rewarding Innovation to Boost Japan’s Drug Discovery Capabilities
May 29, 2023
- Gene Therapy Luxturna Now in Line for Approval in June
May 29, 2023
- Relief Claims OK’ed for 14 More Deaths Possibly Tied to COVID Jabs
May 29, 2023
- Japan Approves Label Expansions for Ultomiris, Skyrizi, Vanflyta
May 26, 2023
- Expert Panel Meeting Canceled Due to Lack of Coordination: MHLW Official
May 26, 2023
- Expedite Introduction of High-Priority Vaccines into National Schedule: Trade Groups
May 25, 2023
- Orphan Tag Granted to Opdivo, Leniolisib, and 6 More APIs
May 24, 2023
- LDP Pharma Study Group Proposes Removing Cap for Social Security Costs
May 23, 2023
- Ophthalmic Mitomycin, OD Tablets for Takecab and Tarlige to Get Listing on May 24
May 23, 2023
- MHLW Cancels Expert Panel Meeting on May 23, Report Delayed
May 23, 2023
- Ferring’s Oral Budesonide for UC Treatment Up for Advisor Review on June 2
May 22, 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…