1. Build a Strong Employer BrandFirst up, let’s talk about your employer brand. Think of it as your company’s personality and reputation. In Japan’s competitive pharmaceutical and medical device industry, it’s crucial to stand out. You need to showcase your…
REGULATORY
Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
A Japanese health ministry panel on October 31 gave the nod to a proposal to transfer authority to conduct GMP inspections for new generics from prefectural governments to the Pharmaceuticals and Medical Devices Agency (PMDA). The Health Sciences Council’s (HSC)…
To read the full story
Related Article
- Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
October 1, 2024
- PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
September 6, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- JPA Wary of FPMAJ Pitch to Allow Non-Pharmacists as Drug Production Managers
May 21, 2024
- Allow Use of OOS Autologous Cell Products via PMD Act Amendment: FIRM
May 21, 2024
- Pharma Industry Wants “Internationally Harmonized” Rules under PMD Act
May 20, 2024
- MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
April 19, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- Japan to Launch Pilot Project for Adopting Fair Market Value in Clinical Trial Costs
February 28, 2025
- LDP Lawmakers Urge Generic Industry to Ramp Up Production
February 28, 2025
- J&J’s Lazcluze, Genmab’s Tivdak and More Drugs in Line for Japan Approval
February 28, 2025
- LDP, Komeito, Ishin Agree to Set Up Consultive Body for Social Security Reform
February 26, 2025
- Coordinate Patent Issues with Originators before Listing: MHLW to Generic Firms
February 26, 2025
In late January, a bill to amend the Pharmaceuticals and Medical Devices Act cleared key legislation review processes by the…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
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…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…