Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
REGULATORY
PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
The Pharmaceuticals and Medical Devices Agency (PMDA) taking over the authority to implement certain GMP inspections from prefectural governments is expected to help boost the quality of generics at large, says a top health ministry officer for pharmaceutical affairs. Discussions…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panelists Wary of Proposed Switch of Generic GMP Inspection Authority to PMDA
July 8, 2024
- Sato Named MHLW’s Top Pharmacy Officer; Kiyohara to Steer Drug Pricing Reform
July 2, 2024
- JPA Wary of FPMAJ Pitch to Allow Non-Pharmacists as Drug Production Managers
May 21, 2024
REGULATORY
- DPP to Co-Sponsor Bill to Make Drug Price Revisions a Biennial Event
December 18, 2024
- Ruling Party Discussions Progress with Off-Year Revisions as a Given
December 18, 2024
- Ruling Bloc’s Draft Budget Policy Says Off-Year Revisions Could Alter, but DPP Calls for Explicit Mention of Repeal
December 17, 2024
- LDP’s Tamura Renews Question over Product Coverage of Off-Year Revisions
December 16, 2024
- Discussions on Generic Company Indices Make Headway towards Full Rollout in Next Revision
December 13, 2024
For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
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…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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…
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…