创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

魏利军. 2017年美国、欧洲和日本批准的新药总结与点评(Ⅰ)[J]. 药学进展, 2018, 42(1): 71-80.
引用本文: 魏利军. 2017年美国、欧洲和日本批准的新药总结与点评(Ⅰ)[J]. 药学进展, 2018, 42(1): 71-80.
WEI Lijun. Summary and Review of New Drugs Approved by FDA, EMA and PMDA in 2017(Ⅰ)[J]. Progress in Pharmaceutical Sciences, 2018, 42(1): 71-80.
Citation: WEI Lijun. Summary and Review of New Drugs Approved by FDA, EMA and PMDA in 2017(Ⅰ)[J]. Progress in Pharmaceutical Sciences, 2018, 42(1): 71-80.

2017年美国、欧洲和日本批准的新药总结与点评(Ⅰ)

Summary and Review of New Drugs Approved by FDA, EMA and PMDA in 2017(Ⅰ)

  • 摘要: 2017年美国食品药品监督管理局(FDA)批准了46个新分子实体(NME)和(或)新生物制品(BLA),其中35个为全球首次获批;欧洲药品管理局(EMA)批准了51个新药,其中4个为全球首次获批;日本药品和医疗器械管理局(PMDA)批准了23个新药,其中3个为全球首次获批。总结并评述这些新药的研发历程、临床研究结果和市场预期,以供参考。

     

    Abstract: In 2017, Food and Drug Administration (FDA) approved forty-six new molecular entities/new biologic license applications, thirty-five of which were granted the first-ever regulatory approval worldwide. European medicines agency (EMA) issued market authorizations to a total of fifty-one new medicinal products, four of which were new approvals globally. Pharmaceuticals and Medical Devices Agency (PMDA) approved twenty-three new medicinal products and three of them are not yet approved in any other countries. The R & D progression, outcomes of clinical research and market expectation regarding these newly approved medicinal products were summarized so as to provide a concise reference to all interested parties.

     

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