The National Medical Products Administration (NMPA) has released the “Medical Representative Management Measures (draft proposal)”, which has been developed in consultation with the Ministry of Public Security, National Healthcare Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and National Bureau of Disease Control and Prevention. The document is open for public feedback until December 13.
Defining the Role of Medical Representatives
The term “medical representative” in the document refers to practitioners employed by the drug marketing authorization holder (MAH) to transmit, communicate, and provide feedback on drug information, and to engage in drug academic promotion activities. The MAH is responsible for managing these representatives, strictly regulating their behavior, and assuming the main responsibility for academic promotion activities.
Eligibility and Qualifications
Eligible medical representatives must hold a bachelor’s degree or above in medicine, pharmacy, or related majors (or intermediate or above professional technical titles), and possess clinical theoretical knowledge and practical experience in drugs, or experience in drug research and development, production, inspection, quality management, and other relevant positions. They must master the knowledge of pharmacology, toxicology, functional indications, combination therapy, adverse reactions, contraindications, and precautions of the promoted drugs.
Training and Assessment by MAH
Medical representatives must also be trained and assessed as qualified by the MAH. For those who no longer engage in related work or cease authorization, the MAH is required to delete their filing information within 30 days.
Compliance and Prohibition of Commercial Bribery
Medical representatives conducting academic promotion activities for drugs should strictly comply with relevant compliance guidelines and behavioral norms. Commercial bribery is strictly prohibited. Medical representatives carrying out academic drug promotion activities in medical and health institutions must obtain the consent of the medical and health institutions.-Fineline Info & Tech
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