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 Reprimands Bipha Over Leakage of Recombinant Organisms in Manufacturing Process for Medway Injection
June 20, 2016
- Kaketsuken-Like Cases Seen Outside Japan Too, Many Exposed through Tip-Offs: PMDA
June 17, 2016
- MHLW Study Group Approves Interim Report toward Full-Scale Operation of MID-NET Database
June 17, 2016
- First Generics for 8 APIs to Join NHI Price List on June 17, 40% Price Rule Applied to Olanzapine
June 16, 2016
- Greater than Expected Need for Drug Discovery Research Using Existing Drugs: AMED Project
June 16, 2016
- MHLW Personnel Reshuffle Announced; Nakayama to Lead FY2018 Drug Pricing Reform
June 15, 2016
- Harvoni, Sovaldi under Review for Risks of Hypertension, Cerebrovascular Disorder
June 13, 2016
- MHLW to Set Up Subcommittee to Help Implement AMR Action Plan
June 13, 2016
- AMED to Establish New Scheme to Support Commercialization of Drug Seeds from Academia
June 10, 2016
- MHLW to Revise Guidelines on Use of Blood Products
June 10, 2016
- Upcoming ICH Meeting Expected to Approve New Members Including Generic Drug Organization
June 9, 2016
- Company Funding for AMED-Backed Clinical Research Also Subject to Legal Regulation: Govt
June 8, 2016
- Use of MID-NET in PMS Could Promote Comparisons of One’s Own Products with Other Treatments: FPMAJ Official
June 7, 2016
- MHLW to Place 2-Year Grace Period on Mandatory Barcode Labeling by March 2021 for Companies with “Special Circumstances”
June 6, 2016
- 141 Trials of Nucleic Acid Drugs Underway Worldwide, but 70% Being Conducted by US Companies: JPO Survey
June 6, 2016
- Cabinet OKs New Growth Strategy, Basic Economic and Fiscal Policy
June 3, 2016
- “Minor Discrepancies” between Marketing Approval and Actual Manufacturing Processes Found for about 70% of Products: MHLW
June 3, 2016
- Clinical Research Bill Didn’t Clear Diet, Now under Continued Review
June 2, 2016
- Tax Hike Delay Kills Feared Price Cuts in 2017, but Concerns Linger over Expensive Drug Debate
June 2, 2016
- MHLW Proposes Discontinuing Supply of Human Thrombin Products
June 2, 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…