LEXICON
No.110 April 12, 2012

Expert discussion
専門協議

Upon filing of a new drug application (NDA; 承認申請), the Pharmaceuticals and Medical Devices Agency (PMDA; 医薬品医療機器総合機構) forms a team of reviewers (審査官) specialized in pharmaceutical and medical sciences, physics, chemistry, biostatistics and all other fields appropriate for reviewing the...

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LEXICON

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…