“Balance” seems to be the keyword for the next drug pricing reform in FY2024. Japan now appears ready to seek a better balance between evaluating innovative medicines and taking tough measures against companies dependent on long-listed products (LLPs) and generic…
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
- Expert Panel Member Sakamaki Wants Pricing Overhaul to Push Generic Industry Consolidation
February 6, 2023
- SCARDA to Beef Up Efforts to Discover Technologies Outside Infectious Diseases: AMED President
February 3, 2023
- MHLW Scratching Head over High-Price Drug Issue, Lecanemab in Mind: Bureau Chief
February 2, 2023
- Chuikyo OKs Use of Multiple Comparators to Price Xocova, Upping of Reduction Cap Mooted for Re-Pricing
February 2, 2023
- Label Expansions for Nubeqa, Rinvoq, Imbruvica Now in Line for Approval
February 2, 2023
Companies don’t plan to fail when it comes to recruitment, but many fail to plan. What happens if your marketing director resigns? A recruiting plan gives your organization the confidence in knowing that whatever happens, there is a process in…
Is policy intervention necessary for Japanese drug makers reliant on off-patent brand-name medicines? Many members of the health ministry’s key…
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…