中英对译-美国FDA新的化学分子实体和生物药 - 药群论坛

nnovation 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.

为了促进创新药研发，对于新的药物和治疗性生物制品的研发创新，FDA的药物评价和研究中心（CDER）在新药每一步开发中对其提供支持。用它的科学的理解评价新的产品，测试和工艺流程，以及新产品的设计，为疾病治疗和使用条件，提供科学和规范的建议，将这些药物新的疗法推向市场。

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.

每年，CDER批准治疗不同疾病的新药物和生物制品。这些产品中的一些是创新药品，从来没有在临床实践中使用。其他的是仿制药，或相关的类似物，以前批准的药品，他们将与这些新药在市场上竞争。

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.

FDA审核的某些药物被列为新分子实体。其中很多产品都含有活性基团，或者是单一成分的药物或者是复合产品产品的一部分，而且之前没有被美国食品药品管理局批准过，这些产品经常为病人提供重要的新疗法。有些NMES虽然是新的结构，但含有活性基团与在先前已被美国FDA批准的产品活性部分基团密切相关。例如，对生物制品申请CDER根据公共卫生服务法案内容351（a）作为FDA审核标准，尽管机构此前已经批准了一些活性基团相关的不同的产品。这与《联邦食品、药品和化妆品法案》化学药品是否为“新的化学实体”的判断依据完全不同。