Foreign exceptional approval system外国特例承認制度Appointed marketing authorization holder選任製造販売業者
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LEXICON
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G1/G2 RuleG1/G2ルールMarch 9, 2018
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New PMP Criteria新薬創出加算の新要件March 9, 2018
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Cost-Based Method原価計算方式July 27, 2017
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Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
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Special expansion re-pricing (Huge-seller re-pricing)特例拡大再算定（巨額再算定）March 4, 2016
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…
“Balance” seems to be the keyword for the next drug pricing reform in FY2024. Japan now appears ready to seek a better balance between evaluating innovative medicines and taking tough measures against companies dependent on long-listed products (LLPs) and generic…
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…