The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
REGULATORY
Counterfeit Drug Panel OKs Final Report, MHLW to Issue GDP Guidelines in FY2018
A health ministry panel on counterfeit drugs generally approved a draft final report on December 20, wrapping up its discussions on ways to ensure the reliability of Japan’s drug distribution system and thwart the entry of fake pills into the…
To read the full story
Related Article
- MHLW Counterfeit Drug Panel Agrees on “Voluntary” Introduction of GDP in Japan
November 14, 2017
- MHLW to Discuss Drug Wholesalers’ License Requirements Related to Their “Operational Systems”
October 23, 2017
- MHLW to Discuss Redefinition of Drug “Seals”, Will Revise List of Examples of Seals Included in 1961 Notification
October 23, 2017
- Japan Introduction of GDP Likely to Begin with Guideline that Calls on Companies to Make “Good Faith Effort”: MHLW Study Group
October 23, 2017
- With Study Group on Counterfeit Drugs to Resume Discussions this Fall, Full-Scale Discussions on Introduction of PIC/S GDP Guidelines Looming
October 10, 2017
- MHLW Study Group on Counterfeit Drugs to Discuss Issues such as GDP Later This Fiscal Year
June 12, 2017
REGULATORY
- FY2023 Extra Budget Clears Diet, 1.4 Billion Yen to Boost Drug Production
December 1, 2023
- Council OKs Public-Knowledge Application for Truvada Use as PrEP for HIV
December 1, 2023
- Average NHI-Market Price Gap for 2024 Revision at 6.0%, Smallest in 30 Years
December 1, 2023
- MHLW Proposes Tightening 40% Entry Pricing for New Oral Generics
November 30, 2023
- Lawmakers Request 4-Valent HPV Vaccination Program for Males to Minister
November 30, 2023
Referrals can be an absolute game-changer in recruitment.When someone in your network recommends a candidate, they often have firsthand insight into the person’s skills, work ethic, values and ambitions. This insider knowledge results in higher quality candidates who are a…
Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…
The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…
A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…
A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…
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…