Notice of the General Department of the State Food and Drug Administration on Issuing the Guidelines for Entrusted Production Site Inspection by Drug Marketing Authorization Holders
release time:2023-12-12
All provinces, autonomous regions, municipalities directly under the Central Government and the Drug Administration of Xinjiang Production and Construction Corps:
In order to strengthen the supervision and management of the production entrusted by the holders of drug marketing license, the State Food and Drug Administration has organized and formulated the guidelines for on-site inspection of production entrusted by drug marketing license holders, which are hereby issued and shall be implemented as of the date of promulgation.
All provincial drug supervision and administration departments are requested to strengthen supervision and inspection of the quality management of the whole production process and the whole life cycle of drug marketing license holders, especially the entrusted production of drugs. The inspection found that drug marketing license holders and drug manufacturers violated the "Drug Administration Law", "Drug Production Supervision and Administration Measures", "Drug Production Quality Management Regulations", "Drug Marketing License Holders Implement the Supervision and Administration of the Main Responsibility of Drug Quality and Safety", "The Announcement of the State Drug Administration on Strengthening the Supervision and Administration of Production Entrusted by Drug Marketing License Holders" and other relevant regulations shall be investigated and dealt with in accordance with laws and regulations.
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