REGULATORY

MHLW Panel Hails Use of Clinical Research Data for Regulatory Submissions, but Wants Requirements to Ensure Safety

March 22, 2021

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

Towards the amendment of the Clinical Research Law five years after its 2018 enforcement, a health ministry panel on March 17 discussed a mechanism that would allow the use of data yielded from non-registration clinical research in regulatory filings, with…

To read the full story

MHLW to Work Out Physician Payment Disclosure Method with Drug Makers towards Amendment of Clinical Research Law
March 28, 2022
MHLW Initiates Discussions on Amendment of Clinical Research Law
January 15, 2021

REGULATORY

Japan Puts CEA Expansion on Hold, Sets 6-Month “Technical Discussions”
December 26, 2025
Gist of FY2026 Drug Pricing Reform Outline
December 26, 2025
Chuikyo OKs FY2026 Drug Pricing Reform Outline, Scraps “Spillovers” but Adds New Follow-Up Rules
December 26, 2025
Japan Cabinet OKs Record Social Security Spending in FY2026 Budget, 105 Billion Yen in Drug Price Cuts
December 26, 2025
MHLW Names 77 Active Ingredients for OTC-Like Drug Charges
December 26, 2025

Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests

By Takashi Ebisawa

The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…

COLUMN

AI: Your New HR BFF (Not Your Replacement!)

By Philip Carrigan

Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…

COMMENTARY

Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise

By Koji Shimomura

Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…