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
- Lawmakers’ League on Vaccines Urges Enhanced R&D System for Homegrown Jabs
May 30, 2022
- Japan Stockpiling Smallpox Jabs amid Monkeypox Surge in Europe, US: Minister
May 30, 2022
- Orphan Tag Granted for Eisai’s ALS Drug, 3 Other APIs
May 30, 2022
- Deregulation Panel Urges Better Data Infrastructure, DCT Promotion to Boost Drug Discovery in Japan
May 30, 2022
- Japan Approves Additional Indications, Dosages for Rinvoq, Adcetris, Rozex, and More
May 27, 2022
- Japan Begins Second COVID Booster for Age 60-Plus, High-Risk Adults
May 26, 2022
- MOF Panel Nudges Full Annual Drug Re-Pricing, Phase-Out for 2% Buffer Zone
May 26, 2022
- Japan Panel OKs Risk Management Measures for Potential Revlimid Generics
May 25, 2022
- MHLW to Issue Guidances on eConsent, Drug Delivery for Virtual Clinical Trials: Official
May 25, 2022
- Japan Regulators Warn of Monkeypox Cases
May 25, 2022
- MHLW Clarifies LVEF-Related Labeling Rule for Heart Failure Drugs: Q&A
May 24, 2022
- G7 Health Ministers Unite for Boosting Measures for Future Pandemics, AMR
May 24, 2022
- 2 mg Pen of Supply-Crippled Ozempic, 3rd Avastin Biosimilar Get Japan Listing
May 24, 2022
- Japanese Regulators to Accept Online NDA Submissions from July
May 23, 2022
- Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
May 23, 2022
- 12 New Probable Cases of Mysterious Pediatric Hepatitis Detected in Japan
May 23, 2022
- PMDA Reviewing New Safety Risks for Opdivo, Keytruda and More
May 23, 2022
- MOF Budget Examiner Presses for “Full” Annual Re-Pricing, Stepwise Cut in 2% Buffer Zone If No Reasonable Basis Given
May 20, 2022
- Sanofi’s CAD Therapy Sutimlimab Up for PAFSC Review on June 2
May 20, 2022
- Orphan Tag for Pfizer’s Gene Therapy Up for Panel Review on June 1
May 20, 2022
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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…