In order to ensure the quality of non clinical evaluation and research of drugs and ensure the use of drugs by the public, recently, the State Food and Drug Administration (SFDA) issued the newly revised "quality management specification for non clinical research of drugs" (SFDA Order No. 34) (hereinafter referred to as the "specification"). There are 12 chapters and 50 articles in the code, including general principles, terms and definitions, organizations and personnel, facilities, instruments and equipment, experimental data, experimental system, standard operating procedures, implementation of research work, quality assurance, data files, clients and supplementary provisions. The specification will come into force on September 1, 2017, and the quality management specification for non clinical research of drugs (Order No. 2 of the former State Food and Drug Administration) issued on August 6, 2003 will be repealed at the same time.
In view of the weak links and existing problems in the past implementation, the code further clarifies the responsibilities of relevant personnel of the research institutions by referring to international practices and combining with China's national conditions, and stipulates that the head of the research institutions shall ensure the standardization of the overall work of the research institutions, and the person in charge of the special subjects shall be responsible for approving the test scheme and summary report; strengthen the main responsibility of the research clients, and set up a special chapter to clarify the Commission The entrusting party shall evaluate the Research Institute, approve the test scheme, and provide authentic and reliable test and control materials and quality information.
To adapt to the emergence of new concepts and the application of new technologies in the field of drug non clinical research, the specification further enriches the management requirements related to research, including the management requirements for multi site research, the management requirements for computerized system, the application requirements for electronic data and electronic signature, etc.; a new chapter on quality assurance is added to ensure the authenticity, standardization and integrity of research data.
The implementation of the standard will help to further improve the level of non clinical drug research in China and ensure the quality of drug research.