(New drug application (NDA)) Review report審査報告書Report on the deliberation results審議結果報告書Clinical trial (study) report治験総括報告書Summary technical documentation (STED)申請資料概要Application for marketing approval; new drug application (NDA)製造販売承認申請書Application dossier申請資料Summary basis of approval (SBA)新医薬品承認審査概要
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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
Whenever an excellent employee or leader leaves, it’s a blow to your organization.The departure of staff is an inevitable part of business, but in a fiercely competitive recruitment landscape like Japan, employee retention is a priority.Not only does retaining staff…
On March 5, Japan unveiled new NHI prices for the FY2024 drug price revision. A Jiho survey found that Tsumura, a specialist in Japanese Kampo herbal medicines, received an astonishing raise of over 24% in its drug prices on a…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
Generic manufacturers in Japan will be required to disclose supply-related information from this June under a new company indicator rule…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
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…