內容目錄
Recently, the Hunan Provincial Food and Drug Administration, the Provincial Health and Health Commission, and the Provincial Traditional Chinese Medicine Bureau jointly issued the “Adverse Reactions and Efficacy Evaluation of Preparations in Medical Institutions of Hunan Province Patients’ Self-declaration”. System Notice” (hereinafter referred to as the “Notice”).
The “Notice” requires that from May 1, 2022, all medical institutions should download the preparation QR code through the “Hunan Provincial Drug Registration Information Supervision System”, and print it on the preparation instructions, labels or inside and outside. prominently on the packaging. In the process of using preparations in medical institutions, patients can log in to the “Hunan Province Patient Self-declaration System for Adverse Reaction and Efficacy Evaluation of Medical Institution Preparations” (hereinafter referred to as the self-declaration system) by scanning the QR code of the preparations through mobile phone WeChat, and report the adverse reactions and adverse reactions of the preparations used. curative effect.
The “Notice” introduces the self-reporting system, stipulates the protection of patient privacy, the responsibilities of medical institutions and the obligation of patients to fill in the report, and clarifies that each city and state market supervision bureau and health committee should The application of the system is included in the scope of supervision of the use of drugs in medical institutions.
The self-declaration system will be developed in 2021, and has been put into trial operation by some medical institutions in the province, and the effect is obvious. The “Notice” makes it clear that the Hunan Provincial Food and Drug Administration will review the information received in the system, regularly monitor risk signals, make full use of it in the re-evaluation, re-registration and daily supervision of preparations, and report the relevant situation to the Provincial Health and Health Commission in a timely manner , Provincial Bureau of Traditional Chinese Medicine.
According to the introduction of Zeng Linggui, a member of the party group and deputy director of the Hunan Provincial Food and Drug Administration, the self-declaration system follows the “people’s health as the center, adherence to risk management, whole-process control, and social co-governance” proposed by the “Drug Administration Law”. Through the direct reporting of adverse reactions and curative effects by patients, the safety and effectiveness of the preparations are evaluated on a patient-centered basis, and the actual clinical situation of the preparations can be more objectively reflected. It is of great significance to promote the construction of Hunan Province’s National TCM Comprehensive Reform Demonstration Zone and the innovative development of TCM. (Yu Canhua)
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