In the race to develop next-generation antibody therapies for solid tumors, antibody drug conjugates (ADCs) are surging, while T-cell engagers…
REGULATORY
New Bar Code Labeling Rules to Take Effect for Oral, Topical Drugs from July 2015
The Pharmaceutical and Food Safety Bureau’s (PFSB) Safety Division and the Health Policy Bureau’s (HPB) Economic Affairs Division issued a joint director’s notification dated June 29 to the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) to inform it of…
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REGULATORY
- MSD’s 21-Valent Pneumococcal Shot Nears Japan Approval; Male Use of Silgard 9 Cleared
July 25, 2025
- Santen’s Glaucoma Drug, Taisho’s Insomnia Med Up for Panel Review on July 31
July 25, 2025
- MHLW Calls for Ongoing Nitrosamine Risk Controls after Self-Inspections
July 24, 2025
- 223 Health Damages Reported for Breyanzi in Japan: October-March
July 24, 2025
- MHLW Plans to Ease Clinical Trial Ad Rules, Eyes Notification by March-End
July 24, 2025
I recently attended a fantastic conference hosted by Prospection Japan, and one speaker, Dr. Joe Ledsam, really blew me away with his insights. He shared some truly fascinating developments about how AI is set to revolutionize healthcare, from how doctors…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
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…