In order to ensure the quality of non clinical safety assessment of drugs and ensure the safety of public drugs, the State Administration of food and Drug Administration recently issued a new revised standard for the quality management of non clinical research on drugs (No. thirty-fourth of the State Administration of food and Drug Administration) (hereinafter referred to as "the standard"). There are 12 chapters and 50 articles in the specification, including general principles, terms and their definitions, organization and personnel, facilities, instruments and equipment and experimental materials, experimental systems, standard operating procedures, the implementation of research work, quality assurance, data files, clients and supplementary provisions. The standard will be implemented on September 1, 2017, and the "standard for quality management of non clinical research on drugs" issued in August 6, 2003 (the original state food and drug administration order No. second) is abolished at the same time.
According to the weak links and problems existing in the past, the standard should draw on the international practice and combine with the national conditions of our country to further clarify the responsibilities of the relevant personnel of the research institutions, and stipulate that the responsible person of the institution should ensure the standardization of the overall work of the research institution, and the project and summary report of the responsible person responsible for the approval. The principal responsibility of the principal is to be studied, and a special chapter is set up to define the research institutions, the accreditation test scheme and the responsibility of providing real and reliable subjects and control products and their quality information.
To adapt to the emergence of new concepts in the field of drug non clinical research and the application of new technologies, the specification further enriches the management requirements related to research, including management requirements for multi place research, management requirements for computerized systems, requirements for electronic data and electronic signatures, and new quality assurance chapter, To ensure the authenticity, standardization and completeness of research data.
The implementation of the code will help to further improve the level of non clinical research and ensure the quality of drug research in China.
(source: Jiangsu food and Drug Administration)