REGULATORY
Japan Mulls Simplifying Drug Delisting Process to Help Ensure Stable Supplies
March 19, 2024
Japan’s health ministry is looking at ways to simplify the current process of withdrawing pharmaceutical products from the market and removing them from the NHI price list as part of its efforts to stabilize drug…

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March 19, 2024
The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) on March 15 presented its specific arrangement for a new round of self-inspections that the health ministry has asked all generic manufacturers to conduct for ensuring the integrity of their products.Earlier…
March 19, 2024
iPark Institute, an operator of Shonan iPark, formally called Shonan Health Innovation Park, said on March 15 that it and its South Korean partner have established local business hubs at each other’s facilities located in Japan and South Korea.This follows…
March 19, 2024
Japanese hospitals are currently bearing most of the expenses required for meeting biosafety regulations associated with gene therapy Zolgensma (onasemnogene abeparvovec) due to an extremely low reimbursement fee, an academic expert said on March 18.Professor…
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…

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