All provinces, autonomous regions and municipalities directly under the central government, the food and drug administration, the PLA General Logistics Department of health and drug administration, China Institute for food and drug control:
In order to further improve and perfect the national drug plan and inspection, make analysis of the national drug plan quality testing and guidance throughout the food and drug inspection institutions, better play the role of sampling in drug risk monitoring and safety supervision and administration of organizations to develop the "national plan of drug testing quality analysis of guiding principle". It is hereby printed and issued to you, please comply with it and notify you of the relevant requirements:
A problem oriented guide drug testing, provide technical support for scientific supervision
Drug testing is an important means of drug supervision, is to improve the quality and safety of drugs, an important technical support for implementation of risk management, scientific management. Drug testing must be found quality problems as the goal, research and analysis of the quality of the drug should be problem oriented, focus on quality problems and risk investigation. Especially to carry out exploratory research, should be on the basis of full investigation, carefully develop research programs, combined with the current drug supervision of the outstanding contradictions and problems, starting from the key factors may affect the quality of drugs and high risk factors, the investigation focused and reveal the potential quality problems.
Two, a solid analysis of drug quality well, promote the effective convergence of sampling and daily supervision
According to the guiding principles of the requirements, according to the standard test and exploratory research results, and evaluate objectively the quality condition of the inspection of the national drug plan testing varieties, to analyze the factors that affect the quality of medicines, analyzed the existing quality standards, raw materials, formulation and production process, packaging materials and illegal production other aspects of the problem, and further strengthen the supervision of the opinions and suggestions of the inspection work to better serve the daily supervision.
Three, strengthen the mining of the testing data, improve the service level of supervision
To further improve the research ability of the testing data analysis and mining, in single species analysis of the quality of the work at the same time, pay attention to the analysis of the same period varieties and sampling the history data of horizontal and vertical contrast, explore the influence regularity in the quality and safety of drugs from the analysis of the trend in reveals the possible presence of systemic and regional issues and "unspoken rule" and other issues, and constantly improve the level of supervision and inspection service.
The provinces (autonomous regions and municipalities) food and drug regulatory authorities in accordance with the requirements of the guiding principle, strengthen organization and coordination, to guide the quality of food and drug inspection institutions to do the national drug testing program variety analysis, standardized writing quality analysis report, and according to the requirements in a timely manner through the "submitted to the national drug testing information system". The quality analysis as an important index for evaluation testing work, strengthen the inspection of performance appraisal. Sampling data platform administration is the construction of a unified organization, and gradually realize the testing data sharing.