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…
ORGANIZATION
Osaka-Based NPO to Take on Outsourcing of GMP Compliance Audit on Drug Substance Makers
An Osaka-based non-profit organization is set to launch an outsourcing service in mid-March to audit drug substance makers’ compliance with Japanese Good Manufacturing Practice (GMP) requirements on behalf of pharmaceutical companies. By tapping the expertise of GMP-savvy retirees of regulatory…
To read the full story
ORGANIZATION
- JOHAS Follows Suit to Suspend 6 Wholesalers from Future Bids
March 29, 2023
- Six Wholesalers Barred from NHO Bids after FTC Confirms Bid-Rigging
March 28, 2023
- Hight Time to Hold Fundamental Debate on Drug Price Revisions: FPMAJ Director General
March 24, 2023
- Japan Umbrella Trade Organ to Beef Up Functions for Lobbying Activity
March 24, 2023
- Over 20% of All Generics under Restricted Shipments: FPMAJ
March 14, 2023
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…
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…