与化学合成原料药相比，发酵化学原料药的生产存在技术上的特殊性。相比传统的化学合成工艺，发酵工艺的优点包括可利用微生物或其他生物组织特异的代谢途径提高反应的选择性并实现更高通量的生产；对很多含复杂结构单元的化学药来说发酵仍是获得足量原料药的唯一途径；由于工艺条件相对温和、所用物料对环境相对友好等特点可提供更高的经济性和可持续性。结合国内外相关法规或指导原则及审评经验，从菌种管理（菌种来源、菌种鉴定、菌种库的建立和内控标准、菌种稳定性）、物料管理（培养基设计、内控标准）、发酵工艺（生产条件、工艺参数）、提取纯化工艺（产品富集、杂质去除）等方面，简要介绍与发酵化学原料药生产工艺部分注册申报相关的基本要求，旨在提高发酵化学原料药生产工艺研发与注册申报的系统性和规范性。

Compared with chemically synthesized active pharmaceutical ingredients (APIs), there are technical peculiarities in the production of fermentation chemical APIs. Advantages of fermentation processes over traditional chemical synthesis include the ability to utilize specific metabolic pathways of microorganisms or other biological tissues to improve reaction selectivity and achieve higher throughput; fermentation is still the only way to obtain sufficient quantities of APIs for many chemicals that contain complex structural units; and the process is relatively benign and environmentally friendly, providing greater economy and sustainability. According to the relevant regulations or guidelines and drug-review practice, the basic requirements related to the manufacture part of the application of the fermentation chemical APIs is demonstrated briefly, with respect to the strain management (source, identification, cell bank establishment and specification, stability), material management (microbiological media design and specification), fermentation process (manufacture conditions, process parameters), extraction and purification process (product enrichment, impurity removal) and other aspects in order to improve the R&D and registration of fermentation chemical APIs to a more systematic and standardized level.