For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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REGULATORY
- MHLW’s Info Gathering System for Pediatric Drugs Goes Live
March 14, 2016
- Japan to Lead Initiatives to Disseminate Regulatory Submission, Review Rules in APEC
March 14, 2016
- MHLW Wants to Continue Price Maintenance Scheme for On-Patent Drugs: Shiozaki
March 11, 2016
- Shiozaki Seeks Understanding for “Huge-Seller” Drug Re-Pricing
March 11, 2016
- Drug Makers Should Have Freewheeling Discussions towards 2018 Reform, MHLW Wants to Pick Their Brains: Official
March 10, 2016
- “Huge Seller” Re-Pricing Dominates Discussions at LDP Study Group
March 10, 2016
- 76 Products Join Japanese Pharmacopoeia: MHLW
March 10, 2016
- Difficult to Enact Clinical Research Bill in Current Diet Session: LDP Health Panel Chief
March 9, 2016
- PMDA Aims to Complete Reviews for 70% of Priority Products within 9 Months in FY2016
March 9, 2016
- MHLW Sorts Out Schemes for Humanitarian Trials, Patient-Initiated Mixed Care
March 8, 2016
- 77.8% of Generics Converge into Single Price Brand in FY2016 Revision: MHLW
March 7, 2016
- Drug Damage Watchdog Says NOAC Makers Paid Big for People Involved in AF Guidelines
March 7, 2016
- Editor’s Pick: Five Healthcare Policy News Headlines for February
March 4, 2016
- MHLW Panel Sets Official Price of Raw Plasma for Coagulation Factor Products at 11,100 Yen per Liter
March 4, 2016
- 439 APIs/1,057 Long-Listed Products Subject to Z2 Price Cut Rule in FY2016 Revisions
March 4, 2016
- AMED Selects 8 Projects for Pre-Orphan Designation System, 3 from Nobelpharma
March 4, 2016
- 416 APIs Eligible for Price Maintenance Scheme in FY2016 Revision; Astellas Only Japanese in Top 10 Premium Winner List
March 4, 2016
- Sovaldi, Harvoni Face 31.7% Price Cut under “Huge Seller” Re-Pricing: MHLW
March 4, 2016
- MHLW to Revise Label Format, Possibly Scrap “Relative Contraindications” and “Careful Administration” Sections
March 3, 2016
- Show Us Your True Self during Surprise Manufacturing Inspections: PMDA Official
March 3, 2016
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Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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…
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…