Sutton Ann
The Biologics Consulting Group, Alexandria, Virginia 22314, USA.
Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S112-4; discussion S144-51. doi: 10.1086/523330.
Marketing approval of biological products by the US Food and Drug Administration must comply with requirements of Code of Federal Regulations title 21 part 25, "Environmental Impact Considerations." An environmental impact statement is usually not required. Environmental assessment is required unless excluded. As naturally occurring substances, biological products qualify for categorical exclusion if manufacture and use do not significantly alter their concentration or distribution in the human environment. The manufacturing process and establishment descriptions in the license application should include enough detail to ensure that waste is controlled and inactivated. During clinical development of a live biotherapeutic product, data should be collected regarding the shedding of live organisms from treated patients. The ability of the live organism to persist in the environment should be assessed, and instructions for safe handling by health care providers and consumers should be incorporated into the package insert.
美国食品药品监督管理局对生物制品的上市批准必须符合《联邦法规汇编》第21编第25部分“环境影响考量”的要求。通常不需要环境影响声明。除非被排除在外，否则需要进行环境评估。作为天然存在的物质，如果生物制品的生产和使用不会显著改变其在人类环境中的浓度或分布，则有资格获得类别排除。许可申请中的生产工艺和机构描述应包含足够的细节，以确保废物得到控制并灭活。在活生物治疗产品的临床开发过程中，应收集有关治疗患者体内活生物体脱落的数据。应评估活生物体在环境中持续存在的能力，并将医疗保健提供者和消费者的安全处理说明纳入药品说明书。
