The National Medical Products Administration Issues New Regulations to Strengthen Oversight of Contract Manufacturing of Drugs
The National Medical Products Administration (NMPA) issued an announcement today (January 6) to strengthen the supervision of contract manufacturing for marketed drugs, clarify the obligations and responsibilities of all parties, and urge marketing authorization holders and contract manufacturers to jointly fulfill their primary responsibility for ensuring drug quality and safety. The announcement primarily consists of three sections: strengthening the responsibilities of contract manufacturers, enhancing supervision and management of contract manufacturing, and other matters. It also includes an appendix that specifies the application materials, issuance requirements, and template for the "Opinion Letter on Contract Manufacturing of Drugs." (CCTV News)
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