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The AAPS journal, ISSN 1550-7416, 2015, Volume 17, Issue 5, pp. 1312 - 1316
...Regulatory Note Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects Ryosuke Kuribayashi, 1,2 Maki Matsuhama, 1 and Kenichi Mikami... 
Biochemistry, general | Biotechnology | generic drug | Biomedicine | approval review | Pharmacy | Japan | Pharmacology/Toxicology | PMDA | PHARMACOLOGY & PHARMACY | Drug Costs | Legislation, Drug | Humans | Drugs, Generic - administration & dosage | Drugs, Generic - economics | Drug Approval - legislation & jurisprudence | Generic drugs | Laws, regulations and rules
Journal Article
Journal Article
Journal of Pharmacy and Pharmaceutical Sciences, ISSN 1482-1826, 08/2016, Volume 19, Issue 2, pp. 290 - 301
Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a... 
PHARMACOLOGY & PHARMACY | Government Regulation | Pharmaceutical Preparations | World Health Organization | United States | Humans
Journal Article
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