New Drug Approvals 2020

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Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.

创新驱动发展。当涉及到新药和生物制剂开发的创新时，FDA的药物评价和研究中心（CDER）对医药企业发展中的每一步都给予支持。凭借其对科学的理解，用于创造新产品、检测和制造程序，以及新产品设计用于治疗的疾病和条件，CDER提供了促使新治疗方法上市所需要的科学和监管建议。 

The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

可及的新药和生物制剂通常意味着病人新的治疗方案的选择和美国民众的健康医药先进了。为了这个目标，CDER支持创新并且在帮助促进新药开发中扮演了关键角色。新药和生物制品的出现往往意味着病人有了新的治疗选择，美国公众的医疗保健也有了进步。因此，CDER支持创新，并在帮助推进新药开发方面发挥关键的作用。

Each year, CDER approves a wide range of new drugs and biological products:

每年，CDER都会批准大量的新药和生物制品:

• Some of these products are innovative new products that never have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2020. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 by the Center for Biologics Evaluation and Research.
• 其中一些产品是从来没有在临床使用过的创新药。以下是一份2020年CDER批准的新分子实体和新治疗用生物制品清单。这份清单不包含疫苗、过敏性产品、血液和血液制品、血浆衍生物、细胞和基因治疗产品、或在生物评价和研究中心2020年批准的其他药物。
• Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
• 其他的是与先前批准过的相同或相关的药物，它们将在市场上与这些产品竞争。有关CDER批准的所有药物和生物制品的信息，请参阅Drugs@FDA。

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.  

为了FDA的审查，某些药物被归类为新分子实体（NEMs）。很多这类产品包含之前FDA没有被批准过的活性成分，无论是作为单一成分药物，还是作为组合产品的一部分；这些产品通常为病人提供重要的新治疗手段。一些药品出于行政目的被定义为NEMs，但是仍然在产品中包含此前被FDA批准的具有类似相关活性成分的活性成分。例如，CDER将根据《公共卫生服务法》第351（a）条提交的申请中的生物制品分类为新分子实体以供FDA审评，不管机构先前是否批准了不同产品中的相关活性成分。FDA对于药品以NME分类的审评目的与FDA在《联邦食品，药品和化妆品法案》中确定是否是新化学实体或是NCE的含义是不同的。