Comparison Study On Electronic Submission Of Drug Application Between America And The European Union And Its Enlightenment To Implementation In China

Electronic submission has become a trend for drug application worldwide in recent years.Electronic Common Technical Document(eCTD)is the common format of electronic submission.This format has demonstrated to markedly improve the efficiency of creation,review,lifecycle management and archive of the application files.To innovate the drug review and evaluation system,the Chinese Center for Drug Evaluation(CDE)has pushed to establish eCTD program in China.And CDE expects to develop a scientific and efficient drug review and evaluation process which complies with international practice.This thesis compared the history of development,the way of submission,regulation structure,the structure of module 1,detailed requirements,and the future development of eCTD for drug application by America and the European Union.The thesis aims to summarize the experience of the developed countries and provide references for the CDE to establish and implement eCTD in China.The concept,the history of development,and the current status of electronic submission worldwide were introduced.The background,significance and the contents of this study were also narrated.Electronic submission is the necessity of history.More than 40 countries have implemented eCTD so for.And China starts to draft regulations and is in a process to establish the eCTD system.The status of implementation of eCTD in America and the European Union were introduced from the aspects of the regulation structure,timetable for the implementation and the structure of eCTD.A comparison was made from the aspects of the history of development,the way of submission,the regulation structure,the structure of module 1,the detailed requirements,and the future development.Both America and the European Union have accumulated extensive experience in implementing eCTD.Comparing the practice by America and the European Union and learning the lessons and experience should enlighten the implementation in china.The status and the progress of eCTD in China were also included.The current regulations were analyzed and the enlightenment for the China regulator and companies was summarized.This study should help achieve a comprehensive understanding of eCTD and establish it in China being compliance with international practice.