Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval-Reference-Cited by-同舟云学术

Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

Author:

Matsushita Shunsuke¹,Tachibana Keisuke¹,Kusakabe Tetsuya²,Hirayama Ryuichi³,Tsutsumi Yasuo¹,Kondoh Masuo¹

Affiliation:

1. Graduate School of Pharmaceutical Sciences Osaka University Osaka Japan

2. Graduate School of Medicine Osaka City University Osaka Japan

3. Graduate School of Medicine Osaka University Osaka Japan

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

Reference24 articles.

1. US Food and Drug Administration.Fast track breakthrough therapy accelerated approval priority review. .

2. European Medicines Agency.Conditional marketing authorization.

3. Notification No. 1020‐1 of 2017 of the PSHEB/PED.

4. Notification No. 0731‐1 of 2017 of the PSEHB.

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