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
- Ethical Hurdles for Placebo-Controlled Studies Could Be Cleared with Certain Designs: PMDA Panel
March 23, 2016
- MHLW Alerts on Risk of Respiratory Depression for Flunitrazepam Injectables, Orders Label Revision
March 23, 2016
- PMDA Chief Kondo Reappointed for 5th Term
March 23, 2016
- Drug Makers Should Ponder Their Role in Community-Based Integrated Care System: MHLW Official
March 22, 2016
- MHLW OKs Cymbalta’s New Pain Indication, Raises Caution on Its Use
March 22, 2016
- New Basic Guidelines for Hepatitis Measures to Push IFN-Free Therapies, Hep B Vaccines
March 18, 2016
- MHLW Official Asks Industry to Discuss Candidates for Essential Medicines
March 18, 2016
- Kamoya Prods Regulatory Science Society to Compile Essential Drug List
March 17, 2016
- Whether to Draw Line between 15 Billion and 100 Billion Yen Sales Thresholds for Re-Pricing Will Hold Key: Kamoya, Nakai
March 17, 2016
- Coefficient for New Generic Pricing “Will Decline Further” if Business Practices Are Not Changed: JGA Official
March 17, 2016
- Opdivo Gets Orphan Status for Hodgkin’s Lymphoma
March 17, 2016
- Nobelpharma CEO Says Sakigake System “Very Helpful”
March 17, 2016
- PMDA Had 43 Advanced Regulatory Advisory Sessions with Startups, Academia in FY2015
March 16, 2016
- Vaccine Panel Wary about Including Synflorix in Public Immunization Program
March 16, 2016
- Oculomucocutaneous Syndrome, Erythema Multiforme Added to ADR List for Halaven
March 16, 2016
- MHLW to Require CTD-Based Submissions for Generics, Effective March 2017
March 15, 2016
- Sales Thresholds for Re-Pricing Rule to Be Key Point of Future Discussions: MHLW Pharma Management Director
March 15, 2016
- MHLW Panel Launches Discussions on New Basic Plan against Cancer
March 14, 2016
- MHLW Panel Roughly OKs Use of MID-NET Database by Drug Makers
March 14, 2016
- No Licensing Deal Clinched for First AMED-Backed Drug Seed
March 14, 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…