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…
REGULATORY
MHLW, Pharma Industry Officials Agree on Conditional Early Approval System
Senior pharmaceuticals-related officials of the Ministry of Health, Labor and Welfare (MHLW) and pharma industry leaders agreed on January 30 to discuss the introduction of a conditional early drug approval system, aiming to give shape to the plan by this…
To read the full story
Related Article
- MHLW to Announce Data Required for Conditional Early Approval
July 12, 2017
- 4 Eligibility Criteria Presented for Conditional Early Approval System
June 2, 2017
- MHLW Councilor Cites Cancer Meds for Conditional Early Approval Scheme
February 10, 2017
- Post-Marketing Conditions Under “Conditional Early Approval System” Remain Unclear: MHLW Councilor Kazuhiko Mori
February 10, 2017
- MHLW to Launch New Framework for Dialogue with Pharma Industry
January 24, 2017
REGULATORY
- Japan Cabinet OKs Extra Budget, 44 Billion Yen for Pharma Measures
December 2, 2024
- Pharma Industry Makes Plea to Komeito to Scrap Off-Year Revisions
December 2, 2024
- Japan Partially Eases Rule for Use of Abortion Pill Mefeego
December 2, 2024
- MOF Panel Wants Prioritized Budgeting for Drug Costs: Subcommittee Acting Chair
December 2, 2024
- MOF Panel Urges Annual Price Revisions on All Drugs in 2025 Budget Proposal
November 29, 2024
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…