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 to Work Out Physician Payment Disclosure Method with Drug Makers towards Amendment of Clinical Research Law
The Japanese health ministry will hold discussions with drug makers on how to disclose their physician payments related to information provisioning and entertainment expenses under the Clinical Research Law, which is expected to be amended five years after its 2018…
To read the full story
Related Article
- New Doctor Payment Disclosure Rule to Apply to Foreign Firms with Japan Subsidiaries
February 21, 2024
- MHLW Announces Revised Rule for Info Disclosure of Physician Payments
February 19, 2024
- Physician Meals Costs, Seminar Expenses Newly Subject to Disclosure under Clinical Trials Act from April
February 2, 2024
- MHLW to Require Pharma to Disclose More Categories of Physician Payments under Clinical Trials Act
January 30, 2024
- All Company-Led Post-Marketing Studies Should Be Regulated by PMD Law upon Clinical Research Law Amendment: Panel
February 21, 2022
- MHLW Panel Hails Use of Clinical Research Data for Regulatory Submissions, but Wants Requirements to Ensure Safety
March 22, 2021
- MHLW Initiates Discussions on Amendment of Clinical Research Law
January 15, 2021
REGULATORY
- MOF Panel Urges Annual Price Revisions on All Drugs in 2025 Budget Proposal
November 29, 2024
- Japan to Require Drug Makers to Set Up Legal Post of “Stable Supply Manager”
November 29, 2024
- Japan Set to Put Up 100 Billion Yen to Support Pharma under Economic Package
November 29, 2024
- Orphan Tag Given to Renalys’ IgA Nephropathy Therapy and 13 More Drugs
November 29, 2024
- Scrap Off-Year Price Revisions, Smaller Japan Firms Face Uphill Battle: DPP Exec
November 28, 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…