出于FDA审评的考量，一部分药物被列为新分子实体（New Molecular Entities ，NME）。许多这些产品含有未经FDA批准的活性部分，作为单一成分药物或作为组合产品的一部分；这些产品经常为患者提供重要的新疗法。另外一些药物被表征为NME是出于管理目的，但仍然包含与以前被FDA批准的产品中的活性部分密切相关的活性部分。例如，便于FDA审评，CDER将根据公共卫生服务法第351（a）节申请提交的生物制品归类为NME，无论FDA以前是否批准了不同产品中的相关活性部分。FDA出于审评目的将药物分类为“NME”不同于FDA基于“联邦食品、药品和化妆品法”的“新化学实体”（new chemical entity，NCE）的定义而做出的决定。
Novel Drug Approvals for 2017
Last Updated: 06/23/2017
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, FDA provides scientific and regulatory advice needed to bring new therapies to market.
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.
Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
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.
For see above for the table.
*This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.