The Food and Drug Administration issued the Quality Management Standards for Non-clinical Drug Research.

Time：

2021-09-15

In order to ensure the quality of non-clinical evaluation studies of drugs and ensure the public use of drugs, the State Food and Drug Administration recently issued the newly revised "Quality Management Standards for Non-clinical Studies of Drugs" (Order No. 34 of the State Food and Drug Administration) (hereinafter referred to as the "Standards"). The Code consists of 12 chapters and 50 articles, including general provisions, terms and definitions, organizational structure and personnel, facilities, instruments and experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data files, client and supplementary provisions. The Regulations will come into effect on September 1, 2017, and the Quality Management Standards for Non-clinical Research of Drugs issued on August 6, 2003 (former Order No. 2 of the State Food and Drug Administration) will be repealed at the same time.

In view of the weak links and existing problems in the past, the Norms draw on the international practice and combine with the national conditions of our country to further clarify the responsibilities of the relevant personnel of research institutions, stipulating that heads of institutions should ensure the standardization of the overall work of research institutions, and special leaders should be responsible for approving test programmes and summary reports. Strengthen the principal responsibility of the research client, set up a special chapter to clarify the client's responsibilities of evaluating the research institution, approving the test plan, and providing real and reliable information about the subject and control products and their quality.

To adapt to the emergence of new concepts and the application of new technologies in the field of non-clinical drug research, the Code has further enriched the management requirements related to research, including the management requirements of multi-site research, the management requirements of computerized systems, the application requirements of electronic data and electronic signatures, etc. A new chapter on quality assurance was added to ensure the authenticity, standardization and integrity of the research data.

The implementation of the Standard will help to further improve the level of non-clinical research on drugs and ensure the quality of drug research.