The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
REGULATORY
Japan Clears Bill to Create Emergency Approval System, Enforcement Slated by Month-End
Japan’s Diet on May 13 enacted a draft bill to amend the Pharmaceuticals and Medical Devices (PMD) Law, which calls for the creation of an emergency approval system for drugs and vaccines. The bill is expected to be enforced by…
To read the full story
Related Article
- Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
May 23, 2022
- Products Filed for Conditional OK Can Be Switched to Emergency Approval: MHLW Official
April 27, 2022
- Upper House Starts Deliberations on PMD Law Amendment Bill
April 25, 2022
- Japan’s Lower House OKs PMD Law Amendment Bill
April 20, 2022
- Emergency Approval Plan Clears Lower House Panel; Opposition Bills Rejected, but Some Ideas Make It into Resolution
April 18, 2022
- Shionogi COVID Pill Doesn’t Meet “Presumed Efficacy” Criteria: HSC Subcommittee Chair
April 13, 2022
- Extension of Emergency Approval Period Would Be Allowed Only Once: MHLW Official
April 7, 2022
- Japan PM Touts Proposed Emergency Approval Scheme as Bill Enters Diet Deliberations
April 1, 2022
- PMD Law Amendment Bill to Enter Diet Debate March 31, CDP’s Counter-Legislation Too
March 30, 2022
- Opposition Party Mulls Counter-Legislation against PMD Law Amendment Bill
March 24, 2022
- Japan Cabinet OKs Draft Bill to Amend PMD Law
March 2, 2022
- Bill to Amend PMD Law Set for Cabinet Approval as Early as March 1
February 24, 2022
- LDP Health Committee OKs Bill to Amend PMD Law
February 18, 2022
- LDP Health Committee to Review PMD Law Amendment Bill Mid-February
February 10, 2022
REGULATORY
- METI to Bankroll 95.5 Billion Yen in 23 Projects to Build Vaccine Sites, Moderna Among Them
September 22, 2023
- MHLW Panel Members Call for Tightening Advertising Regulations for Off-Label GLP-1 Use
September 22, 2023
- Sitagliptin Increases Cancer Risk in 1 in 115,000 People with Current Global Impurity Limit: Makers
September 22, 2023
- Chuikyo Rep Grumbles at Too Many Industry Requests, FPMAJ Chief Wants Health Coverage Dabate
September 21, 2023
- Pharma Groups Stand in Unity to Push Reward for Innovation, Price Maintenance
September 21, 2023
As Japan moves into elaborate discussions on the potential reform of its cost-effectiveness assessment (CEA) in FY2024, members of a…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
The Japanese government on September 12 approved Moderna’s updated monovalent COVID-19 vaccine directed at the Omicron XBB.1.5 strain, following its…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…