No.102 February 13, 2012

In vitro diagnostic (IVD); extracorporeal diagnostic (agent)
In vivo diagnostic (agent)
Laboratory study; clinical test; clinical assay
Laboratory (lab) test
Physiological function test

The Pharmaceutical Affairs Law (PAL; 薬事法) defines in vitro (extracorporeal) diagnostic agents (commonly 体外診断薬 and 体外診断用医薬品 in the PAL) as “drugs which are intended to be solely used to diagnose diseases and which are not directly applied to or introduced...

To read the full story


By Yuki Kato

Japan plans to revise its guidelines on the drone delivery of medicines later this month, which would mark the first revision since they were established two years ago. Service providers are closely watching how they will be revised, with calls…

By Eric Persoff

The healthcare supply chain in Japan, as in all major markets, consists of biopharmaceutical manufacturers selling to wholesalers who in turn sell to hospitals, clinics, and pharmacies, where the drugs are finally dispensed to patients. Each party ideally contributes value…

By Yoshinori Sagehashi

The health ministry’s key expert panel on February 15 agreed on the need to consolidate the Japanese generic sector to…

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…