The traditional HR Business Partner (HRBP) model, once the gold standard for HR delivery, is undergoing a significant transformation. Many organizations, particularly in industries like pharmaceuticals, are moving towards a more agile resource model, aiming to streamline HR operations and…
REGULATORY
MHLW Issues ICH E19-Based Guideline on Selective Approach to Safety Data Collection in Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) has issued a new guideline on safety data collection from late-stage and post-registration clinical trials. Based on the ICH’s E19 Guideline, the new guidance is expected to facilitate the efficient conduct of…
To read the full story
REGULATORY
- Japan Govt OKs Economic Package to Counter US Tariff Impact
April 28, 2025
- ASKA’s Contraceptive, Vabysmo Label Expansion Now in Line for Japan Approval
April 28, 2025
- MHLW/PMDA, FDA Philippines to Boost Regulatory Cooperation
April 28, 2025
- LDP Members Raise No Call for Tax Cuts, Fret Inflationary Impact on Medical Facilities: Fiscal Reform HQ
April 25, 2025
- Japan to Buttress Regulatory Communication Efforts for Drug Originators Overseas
April 25, 2025
Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
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…