| Objective：To provide references and suggestions for applicants of the change research of drug technology transfer. Methods：This study collected the requirements, which were made by the Center For Certification And Evaluation, Guangdong Drug Administration, of supplementary information for application materials of drug technology transfer. Items were classified in sorts, and analyzed for existing problems. Results: Analyzed 257 supplementary informations of 59 requirements, most requirements of supplementary information appeared in 5 aspects, namely the quality standards and analytic method validation(23.7%) , quality contrast research (19.5%), production technology and process control (12.8%) ,control of materials(10.5%),equipment and the validation (8.9%).According to the different classifications of the application varieties, the problems of traditional Chinese medicine(TCM) are mainly due to process control, quality contrast research and stability study of intermediate. Most requirements to Active Pharmaceutical Ingredient (API) are extend to the quality standards of starting material, and control parameters of the process. The reasonableness and quality research of chemicals received more supplementary informations. Conclusion: Aiming at the applicants’ lack of information and research, this paper gave rational recommendations according to the different classifications of the application varieties. Researchers and applicants that plan to carry out change research of drug technology transfer can take this as reference, and should make comprehensive and regulated research programs at the establishment of the change research, so as to improve the quality and efficiency of the change research. |