Chapter IV Drug Intensive Surveillance

Article 41 Drug manufacturers shall frequently examine the safety of their drug products and conduct intensive surveillance on drugs within the New Drug Observation Period and on imported drugs within 5 years after first importation, and they shall summarize, analyze, evaluate and report the monitoring data as required. For other drugs products, intensive surveillance shall be conducted voluntarily based on the drug safety information.

Article 42 Drug regulatory departments at or above the provincial level may request drug manufacturers to conduct intensive surveillance on specific drugs based on information of clinical drug use and ADR monitoring; when necessary, they may directly organize ADR monitoring institutions, medical institutions and scientific research institutions to conduct intensified drug monitoring.

Article 43 ADR monitoring institutions at or above the provincial level shall be responsible for the supervision and inspection of intensive surveillance carried out by drug manufacturers, and conducting technical evaluation of the monitoring reports.

Article 44 Drug regulatory departments at or above the provincial level may, jointly with the health administrative departments at the same level, designate medical institutions as surveillance sites undertaking drug intensive surveillance.

Chapter V Evaluation and Control

Article 45 Drug manufacturers shall analyze and evaluate the ADR reporting and monitoring data collected and spontaneously conduct drug safety studies.

For drugs that have been verified as causing serious ADRs, drug manufacturers shall promptly inform the health professionals, patients and the public of the ADRs and information on rational drug use by various effective means; measures such as revising labels and package inserts, suspension of production, sales and use, and recall shall be taken to reduce and prevent the recurrence of ADRs. For drugs causing significant adverse reactions, drug manufacturers shall voluntarily apply for canceling the approval documents.

Drug manufacturers shall report the drug safety information and measures taken to the provincial drug regulatory departments where the enterprises are located and to the SFDA.

Article 46 Drug distributors and medical institutions shall analyze and evaluate the ADR monitoring and reporting data collected and take effective measures to reduce and prevent the reoccurrence of ADRs.

Article 47 Provincial ADR monitoring institutions shall conduct comprehensive analysis on ADR reports received quarterly, extract and evaluate safety information that needs attention, propose risk management measures, and promptly report to drug regulatory departments and health administrative departments at the provincial level and the National Center for ADR Monitoring.

Provincial drug regulatory departments may, based on the results of analysis and evaluation, take such measures as suspension of production, sales and use, and drug recall, and carry out supervision and inspection; at the same time, they shall inform health administrative departments at the same level of the measures taken.

Article 48 The National Center for ADR Monitoring shall conduct comprehensive analysis on serious ADR reports received quarterly, extract and evaluate safety information that needs attention, propose risk management measures, and promptly report to the SFDA and the Ministry of Health.

Article 49 Based on the results of drug analysis and assessment, the SFDA may request enterprises to conduct studies on drug safety and effectiveness. When necessary, measures such as ordering enterprises to revise package inserts, suspension of production, sales and use, and drug recall shall be taken; for drugs with serious adverse reactions, the drug approval documents shall be revoked; and the Ministry of Health shall be informed of all measures in a timely manner.

Article 50 ADR monitoring institutions at or above the provincial level may, based on the need for analysis and evaluation, request drug manufacturers, distributors and medical institutions to provide relevant materials, and relevant units shall actively provide support.2019-12-16