FDA《合规政策指南手册》（Manual of Compliance Policy Guides）
Manual of Compliance Policy Guides
FDA发布《合规政策指南手册》，说明合规政策指南（CPGs）用于指导FDA工作人员评估和执行行业合规，通常在现有法律、法规或指南未覆盖或需澄清时确立FDA政策与解释。CPGs按主题分为通用、生物制品、器械、人用药品、食品与色素及化妆品、兽药等章节。需要新增或修订CPG的FDA工作人员应联系相关中心，第1章（通用）事务联系检查与调查办公室下属的检查政策处（DIP）。
Foreword
Compliance Policy Guides (CPGs) are intended to advise Food and Drug Administration (FDA) staff as to the Agency's strategy when assessing and enforcing industry compliance.
They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.
The CPGs are organized by subject-matter in the following chapters:
- General
- Biologics
- Devices
- Human Drugs
- Food, Colors, and Cosmetics
- Veterinary Medicine
FDA staff who identify a need for a new or revised CPG should contact the relevant FDA Center. For Chapter 1 (General) inquiries, contact the Division of Inspectorate Policy (DIP) within the Office of Inspectional Performance Optimization, Office of Inspections and Investigations at [email protected]. DIP can also help identify the appropriate contact if needed.
来源：FDA 官方药品与生物制品信息 · fda.gov