LEXICON
No.100 January 30, 2012

Foreign exceptional approval system
外国特例承認制度
Appointed marketing authorization holder
選任製造販売業者

Under the “foreign exceptional approval system” (外国特例承認制度), an overseas pharmaceutical company may directly file an application for marketing approval (製造販売承認) with Korosho in order to market its product manufactured outside Japan and imported into Japan by appointing a domestic drug...

To read the full story

LEXICON

By Izuru Ando

While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…

By Philip Carrigan

As the year 2022 draws to a close, what are managers thinking at the world’s leading pharmaceutical companies and medical device companies? We surveyed 86 managers at these companies to find out what’s on their minds.For many managers, a common…

A Japanese reimbursement policy panel on November 16 saw a continued scuffle between members representing healthcare providers and payers over…

Deloitte Tohmatsu Consulting proposed three drug pricing schemes designed to trigger the consolidation of generic makers on October 27, offering…

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…