全文｜中华人民共和国药品管理法实施条例

Core Viewpoint - The article outlines the regulatory framework for drug management in China, emphasizing the importance of public health, scientific principles, and ethical standards in drug research, production, and supervision. Group 1: General Principles - Drug management activities should prioritize public health and adhere to scientific and ethical principles while comprehensively preventing risks [1] - The government aims to enhance the drug innovation system, supporting clinical value-oriented drug research and innovation, and promoting the development of traditional Chinese medicine [1] Group 2: Drug Research and Registration - Drug research activities must comply with non-clinical and clinical trial quality management standards to ensure data integrity and traceability [3] - Non-clinical safety evaluation studies must be conducted by qualified institutions, with a decision on qualification applications made within 20 working days [6] - Clinical trial sponsors must select capable institutions and researchers, ensuring participant protection and proper management of trial data [8] Group 3: Drug Production - Drug production requires a license from local government departments, with a review process that takes 30 working days [17] - The production license is valid for five years, and renewal is necessary for continued production [17] - Drug manufacturers must establish a quality assurance system and comply with production quality management standards [24] Group 4: Drug Operation - Drug operating activities require a license, with a review process of 20 working days for applications [26] - The operating license is also valid for five years, necessitating renewal for continued operations [26] - Drug retail enterprises must sell prescription drugs only with a valid prescription [27] Group 5: Drug Quality Management - Drug quality management includes monitoring adverse reactions and establishing risk management mechanisms [13] - Drug quality standards must align with national standards, and any changes must be reported to the relevant authorities [10] - The government encourages the development of standardized planting and breeding of traditional Chinese medicinal materials [21] Group 6: Legal Responsibilities - Violations of drug management regulations can result in significant fines and penalties, including the revocation of licenses [47][48] - Entities providing false information in applications for drug-related licenses face severe penalties, including a ban on future applications for up to ten years [48]