【CODEX】药品生产监督管理办法（5-7）-EN
Chapter V Supervision and Inspection
Article 38. The food and drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and inspection of drug manufacturers in their administrative regions. The operational mechanisms and management systems for the implementation of supervision and inspection must be established to clarify the functions of supervision and inspection of the municipal food and drug regulatory authority of city consisting of districts and the food and drug regulatory authorities at county level.
The CFDA may supervise and inspect drug manufacturers directly. It supervises and spot-checks the supervision and inspection work of the food and drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government, as well as the implementation and authentication of Good Manufacturing Practice for Pharmaceutical Products of manufacturers.
