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
MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
The Ministry of Health, Labor and Welfare (MHLW) will make decisions on whether to allow the use of data from “specified clinical research” on a case-by-case basis, but only under certain conditions, such as when registrational trials are deemed infeasible,…
To read the full story
Related Article
- MHLW Official Sees More “Specified Clinical Research” Data Used in Regulatory Submissions to Fill Industry-Academia Void
July 20, 2022
- NCC Doctor Hails MHLW’s Policy on Use of Clinical Research Data in Regulatory Filing
June 22, 2022
- MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
April 4, 2022
REGULATORY
- Espha’s Januvia Generic on Approval Roster towards June Listing
February 18, 2025
- “Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
February 17, 2025
- Japan to Approve EquMet Generics, More Copycats toward June Listing
February 17, 2025
- MHLW Lays Out Procedures for Transition to Trivalent Flu Shots
February 17, 2025
- J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
February 14, 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…