Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
Clinical Research Bill Set to Sail through Extra Diet with Opposition Backing
As the Diet convened a 66-day extraordinary session on September 26, the eyes of the pharmaceutical and healthcare circle are on a bill for the legal regulation of clinical research, which is now seen almost certain to be passed into…
To read the full story
Related Article
- Clinical Research Law Promulgated
April 17, 2017
- Clinical Research Bill Passed into Law
April 7, 2017
- Clinical Research Bill Passes Lower House
March 23, 2017
- Clinical Research Bill Clears Lower House Health Panel
March 21, 2017
- Clinical Research Bill Unlikely to Clear Extra Diet
December 5, 2016
- Shiozaki Asks for Early Enactment of Clinical Research Bill
October 20, 2016
- Clinical Research Bill Didn’t Clear Diet, Now under Continued Review
June 2, 2016
- Clinical Research Bill Unlikely to Clear Diet in Current Session
May 27, 2016
- Clinical Research Bill to Enter Diet Deliberations on May 20, Might Be Enacted June 1
May 19, 2016
- Clinical Research Bill OK’ed by Cabinet, Now Up for Diet Deliberations
May 13, 2016
- In a Flip-Flop, LDP Aims to Enact Clinical Research Bill in Current Diet Session
April 28, 2016
REGULATORY
- Japan Gets Down to the Business of Solving Drug Loss, New Scheme Begins with 78 Meds
November 26, 2024
- MHLW Proposes Upping Copay Limits in High-Cost Medical Expense Scheme
November 25, 2024
- Japan’s New Economic Package Covers Pharma-Related Steps, but Not Repeal of Off-Year Revisions
November 25, 2024
- AstraZeneca’s COVID Antibody, Daiichi’s TROP2 ADC, and More Up for Review on Dec. 6
November 25, 2024
- Pharma Renews Call for Abolishing Off-Year Revisions, but MHLW Stays Put with Honebuto
November 22, 2024
For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
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…