受权发布|中华人民共和国药品管理法实施条例

General Principles - The regulation is established based on the Drug Administration Law of the People's Republic of China, emphasizing public health and scientific principles in drug management [2] - The government aims to enhance the drug innovation system, support clinical value-oriented drug research, and promote the development of traditional Chinese medicine [2][3] Drug Research and Registration - Drug research activities must comply with non-clinical and clinical trial quality management standards, ensuring data integrity and traceability [4] - Non-clinical safety evaluation studies must be conducted by qualified institutions, with a 20-working-day review period for applications [4] - Clinical trial sponsors must select capable institutions and researchers, ensuring participant protection and data management [6][8] - The State Council's drug supervision department can expedite drug registration processes for qualifying applications [8] Drug Production - Drug production requires a license from provincial drug supervision departments, with a 30-working-day review period for applications [20] - Drug production licenses are valid for five years, requiring renewal for continued production [20] - Drug manufacturers must establish a quality assurance system and comply with production quality management standards [21][28] Drug Operation - Drug operating activities require a license from local drug supervision departments, with a 20-working-day review period for applications [30] - Drug operating licenses are also valid for five years, necessitating renewal for continued operation [30] - Drug retail enterprises must sell prescription drugs only with a valid prescription [31] Drug Quality Management - Drug quality standards must align with national standards, and manufacturers must evaluate and revise their standards as necessary [11] - The State Council's drug supervision department is responsible for establishing a unified drug traceability standard [46] Supervision and Management - Drug supervision departments can conduct inspections and take necessary measures to ensure compliance with regulations [63] - The State Council's drug supervision department is tasked with setting up national drug professional technical institutions for better oversight [47] Legal Responsibilities - Violations of drug management regulations can result in significant fines and penalties, including the revocation of licenses [79][80] - Entities providing false information in applications for drug-related licenses face severe penalties, including a ban from drug production and operation for ten years [82][83]