Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
ORGANIZATION
Create NDA Category Modeled after FDA’s “505(b)(2)” Pathway: JEMA
The Japan Established Medicine Association (JEMA) is calling for the creation of a new regulatory application category for “improved drugs” in Japan, which would correspond to the “505(b)(2)” approval pathway that is already in place in the US. According to…
To read the full story
Related Article
ORGANIZATION
- US Tariffs Would Hinder Access to Innovative Drugs: JPMA President
April 24, 2025
- JPMA to Discuss Ways to Promote DX in Commercial Production in FY2025
April 23, 2025
- New JPMA Task Force to Respond to ICH-GL and PMD Act Amendments
April 22, 2025
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- PhRMA HTA Taskforce Warns CEA Expansion Will Accelerate Drug Loss in Japan
April 18, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
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…