Core Viewpoint The revised "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" aims to enhance drug research, registration, production, and safety management, effective from May 15, 2026. The regulations focus on supporting innovative drug development, improving drug quality, and ensuring safety in drug management. Group 1: Drug Research and Registration - The regulations support drug research and innovation guided by clinical value, encouraging the development of new drugs and their clinical promotion [1][3] - A fast-track registration process for drugs is established, along with clear procedures for re-registration and mechanisms for converting prescription drugs to over-the-counter status [1][12] - Special market exclusivity periods are granted for pediatric drugs and treatments for rare diseases, with data protection for drugs containing novel chemical components [1][14][15] Group 2: Drug Production Management - The regulations enforce strict management of drug production, emphasizing the responsibilities of drug license holders during contract manufacturing [1][24] - Specific management requirements for traditional Chinese medicine (TCM) products are outlined, including production and sales regulations [1][29] Group 3: Drug Safety Regulation - Enhanced drug safety supervision measures are specified, including detailed procedures for quality inspection and the right to request re-examination of inspection results [2][50] - Legal responsibilities for violations are clearly defined to ensure compliance and accountability in drug management [2][52] Group 4: Drug Distribution and Use - The regulations improve the management of online drug sales, holding third-party platforms accountable for the quality of drugs sold [1][35] - Medical institutions are required to strengthen their drug management practices to ensure the quality of drugs used [1][49]

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]

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]

General Principles - The regulation is established based on the Drug Administration Law of the People's Republic of China, emphasizing public health and adherence to scientific and ethical principles [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] Drug Research and Registration - Drug research activities must comply with non-clinical and clinical trial quality management standards, ensuring 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 data management [8] Drug Production - Drug production activities require an application to the provincial drug supervision department, with a decision made within 30 working days [19] - Drug production licenses are valid for five years, and renewal applications must be submitted before expiration [19] Drug Operation - Drug operating enterprises must apply for licenses, with a decision made within 20 working days [28] - Drug operating licenses are also valid for five years, requiring renewal for continued operation [28] Drug Quality Management - Drug quality standards must align with national standards, and any necessary revisions must be reported to the drug supervision department [11] - The government supports the development of drug quality assurance systems and encourages monitoring of adverse drug reactions [15] Market Exclusivity - New pediatric drugs and treatments for rare diseases may receive market exclusivity for up to two years and seven years, respectively, under certain conditions [21][12] - The specific conditions for market exclusivity will be determined by the drug supervision department [13] Supervision and Management - Drug supervision departments have the authority to conduct inspections and enforce compliance, including the ability to seize products that may harm public health [41] - A unified traceability standard for drugs will be established to ensure accountability throughout the supply chain [66] Legal Responsibilities - Violations of the regulations can result in significant fines, including penalties for the sale of unapproved drugs and unauthorized production practices [50][51]