REGULATORY

Expert Panel Agrees on Need for Generic Industry Shakeup, Company Criteria Floated

By Yoshinori Sagehashi February 16, 2023
The health ministry’s key expert panel on February 15 agreed on the need to consolidate the Japanese generic sector to rectify the inefficiency of its high-mix low-volume manufacturing practices. Now the focus is on “how?” Members raised two opposite opinions,…

To read the full story

Related Article

REGULATORY

By Yoshinori Sagehashi

Pharmaceutical companies are giving high marks to Japan’s drug pricing reform for FY2024. According to a survey conducted by Jiho, 51% of all respondents expressed a positive opinion of the reform, saying that they were “somewhat satisfied” with it. The…

By Philip Carrigan

Your reputation as an employer matters.A survey completed by Indeed found that 95% of job seekers found a company’s reputation was an important consideration.When top talent is a scarce commodity, companies need to do more than just make an offer.…

Japan’s health ministry approved a batch of medicines for broader labels on February 9 including Nippon Boehringer Ingelheim’s SGLT2 inhibitor…

By Izuru Ando

Generic manufacturers in Japan will be required to disclose supply-related information from this June under a new company indicator rule…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

A health ministry panel on pharmaceutical regulations on December 13 discussed the need for confirmatory trial data in Japanese subjects for drugs to treat ultra-rare diseases. The industry proposed waving the implementation of Japanese studies when deemed appropriate in a…

By Yoshinori Sagehashi

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…