The Status of the Electronic Common Technical Documents Implementation in China: A Comparative Study Based on the USA and EU
Abstract
Objective
This paper aims to analyze the problems that China may face in the eCTD implementation process and provide corresponding solutions so as to promote the stable and high-speed development of China's eCTD construction.
Method
This study mainly uses literature research method and comparative analysis method. By searching and analyzing relevant literatures, laws and regulations at home and abroad, this study chooses the USA, the EU and China as objects and makes comparative analysis from three aspects of policy tools, regulatory guidelines and implementation situation among three regions.
Results
As for policy tools, the USA and EU rely on environmental tools, while provide less support for supply-oriented and demand-oriented tools. As for regulatory guidelines, the guidelines of the USA are more comprehensive and detailed; while the guidelines of the EU are looser and focus on practice, but both maintain a high updating frequency. As for implementation situation, from recommendation to compulsory implementation, the USA and EU both give up the one-step approach, and the situation is generally good.
Conclusion
The obstacles to the promotion of eCTD in China mainly focus on the implementation status of CTD, the perfection degree of policy system, the level of software construction and the status of professional personnel training. Therefore, government should set up reasonable transition mode, improve the policy system and infrastructure construction, and cultivate professional talents. Enterprises should take an active part in the implementation of eCTD, choose the appropriate way of cooperation with software suppliers, and build internal professional registration teams.
Downloads
References
2. China's 2019 Annual Drug Evaluation Report [Internet]. China: Center for Drug Evaluation (CDE); 2020 Jul 30 [cited 2021 Jul 24]. Available from:
http://www.cde.org.cn/news.do?method=viewInfoCommon&id=68f4ec5a567a9c9a
3. The Opinions on the Reform of the Drug and Medical Device Evaluation and Approval System [Internet]. China: The State Council of the PRC; 2015 Aug 09 [cited 2021 Jul 24]. Available from:
http://www.gov.cn/zhengce/content/2015-08/18/content_10101.htm
4. Rothwell R, Zegveld W. An Assessment of Government Innovation Policies. Review of Policy Research [Internet]. 1984 [cited 2021 Jul 24]. Available from:
https://xueshu.baidu.com/usercenter/paper/show?paperid=a95197785d0225546ce35d3b0650acd1&site=xueshu_se
5. Dong-ang Li, Yi Liang. Research on the Strategy of Implementing eCTD Format in Chinese Drug Registration. Mechanical and Electrical Information. 2018;(08):4-10.
6. Xiaolin Zhu, Bin Li, Dongsheng Yang, Bin Jiang. Implementation strategy for eCTD electronic submission in China based on experiences from ICH countries. Journal of Chinese Pharmaceutical Sciences. 2016;25(07):552-8.
7. Joanne H, Kevin H, Boris R, Kousalya V, Albert DA. eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway: The Time Has Come for Advertising and Promotion to Submit in Module One. Therapeutic innovation ®ulatory science [Internet]. 2020 [cited 2021 Jul 24]. Available from:
https://schlr.cnki.net/zn/Detail/index/SJPDLAST/SJPDFE1294EA7BD8BDCDD01CD154E2805935
8. Jiaxi Du, Junxia Wang, Yaoyao Yang, Nuo Yang, Shanshan Kang. ICH eCTD study and recommendations for implementation in China. Chinese Journal of New Drugs. 2020;29(19):2166-71.
9. Dongsheng Yang, Jianzhao Niu, Mingdi Xu, Haiyan Cai, Xian Sun, Guangchao Zhang. A brief introduction to ICH electronic common technical documents. Chinese Journal of New Drugs. 2019;28(12):1440-4.
10. European Medicines Agency (EMA). EMEA implementation of electronic submissions: statements of intent. Europe: European Medicines Agency (EMA); 2008 Jan 28 [cited 2021 Jul 24]. Available from:
https://www.ema.europa.eu/en/emea-implementation-electronic-submissions-statements-intent
11. Harmonised Technical Guidance for eCTD Submissions in the EU v4.0 [Internet]. Europe: European Medicines Agency (EMA); 2016 April [cited 2021 Jul 24]. Available from:
http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v4%200-20160422-final.pdf
12. Suchanek A, Ostermann H. The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process. Drug Inf J. 2012;46(1):124-39.
13. Specifications for eCTD Validation Criteria version 3.8 [Internet]. America: Food and Drug Administration (FDA); 2019 Jan 22 [cited 2021 Jul 24]. Available from:
https://www.fda.gov/media/87056/download
14. eCTD validation criteria v7.1 [Internet]. Europe: European Medicines Agency (EMA); 2018 Feb 03 [cited 2021 Jul 24]. Available from:
http://esubmission.ema.europa.eu/ectd/index.html
15. Yi Fan. Opportunities, challenges and countermeasures for the implementation of eCTD. Chinese Journal of New Drugs. 2019;28(16):1997-2003.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
