Résumé
In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.
Résumé
Objective:To put forward relevant policy recommendations for strengthening the quality control of clinical trial drug production in China. Methods:The objective differences of clinical trials and marketing drugs in the production and management as-pects were in-depth analyzed, and the lessons in clinical trial drug production quality supervision and management experience were drawn from the FDA and the European Union EMA. Results and Conclusion:Based on the particularity of clinical trial drug produc-tion management,it is suggested to formulate the administrative rules and technical standards for the quality control of clinical trial drug production and amend relevant laws and regulations timely so as to achieve the purpose of strengthening the quality supervision of drug production in clinical trials.
Résumé
Based on the research results of suitability evaluation of growth and production quality, a functional production cultivation regionalization with high feasibility and operability to solve the problem of the separation of high quality and high yield were formatted for protection, wild monitoring, and cultivation of this plant by weighted sum of spatial suitability data of ecology and quality, as well as integrated with land use and cover data. The results of the study revealed that good quality and high yield area were mainly distributed in the original production areas in Sichuan province and where could carry out monitoring and commercialization cultivation. This method is expected to overcome shortage of traditional regionalization methods difficult to distinguish the contribution of ecological factors and quality factors, which provide an innovative theory and methodology for regionalization, and is helpful to practical application of wild resource protection, nature research, monitoring, and commercialization cultivation for Chinese material medica.