Accelerating international integration China's drug registration will move towards the era of eCTD.

On September 21, 2020, the official website of the State Drug Administration, CDE, issued the Notice on The Re-Public Request for Comments on the Electronic General Technical Document (eCTD) of Pharmaceuticals, deadline for comments: October 21, 2020, let's Once again saw the determination and action of the China Drug Administration to speed up the integration with the international standards, accelerate the encouragement of drug innovation, promote drug registration technical standards and international standards of the policy landing, this article for everyone combed the human drug registration application drug electronic general technical document (eCTD) related knowledge points, together to learn to understand the knowledge of eCTD.
I. The International Coordinating Council (ICH), as an extremely important international organization in the field of pharmaceuticals, mainly coordinates the technical requirements of drug registration in various countries, so that drug manufacturers can apply unified registration information to improve the efficiency of new drug research and development, registration and market.
ICH issued the first version of the eCTD guidelines in October 2003 to promote the declaration and review of declarations in the form of eCTDs, and the current internationally accepted version of the eCTD guidelines is 3.2. Version 2, which is more mature, is currently phase 4, and the final adoption phase, in which the ICH General Assembly, in consultation with the Management Committee, adopts the guiding principles, which are then adopted by members of ICH regulatory bodies, as shown in the table below for the M8 Electronic Common Technical Document (eCTD) series of documents.
eCTD, as a drug declaration and review management method in developed countries and regions such as Europe and the United States, has been widely used, has also been highly recognized by the international pharmaceutical community, more countries gradually began to adopt, some countries completed the gradual implementation, in 2003, the United States and the European Union first began to implement eCTD;
2. As an advanced and formatted standard for drug registration and declaration, eCTD in China's eCTD has greatly reduced the workload of drug applicants and reviewers, and significantly improved the efficiency of data exchange between pharmaceutical companies and drug regulatory agencies, and accelerated the speed of drug registration and approval, which has been accepted by drug regulatory authorities in more and more countries. The opinions of the medical device review and approval system (Guofa (2015) No. 44) requirements, comprehensive drug review and approval system reform, the implementation of eCTD system construction work, in accordance with the new system to implement electronic declaration and review, reform the previous drug acceptance process and methods, actively promote drug registration technical standards in line with international eCTD, many times issued eCTD-related notices and norms, in order to maximize the safety of registered drugs.
III, eCTD file format structure introduction eCTD file format, a full set of registration documents divided into 5 modules, module 1 as a separate piece of file has regional specificity, the other 4 modules for eCTD format files, each module covers different declaration content, and has a clear hierarchy, through the structure of the file directory, can quickly find and locate different content of the declaration data, as an internationally accepted registration file writing format, with universality.
five modules complement each other, from pharmaceutical research to clinical trials, registered reviewers can understand the successful process of drug development through a full set of eCTD documents, providing a strong guarantee for the approval of drug launches.
4. Market Outlook After eCTD Implementation September 15, 2020 General Secretary Xi Jinping's important article "Building a strong public health system to provide a strong guarantee for the health of the people", the article stressed the need to speed up the integration of China's short board in life sciences, biotechnology and other fields; On September 21, 20, CDE again issued the Notice on Re-publicly Soliciting Opinions on The Electronic General Technical Document (eCTD) of Pharmaceuticals, so that we can once again see the determination and action of the China Drug Administration to accelerate its integration with the international standards, accelerate the encouragement of drug innovation, and speed up the filling of China's short boards in the field of registration and declaration of life sciences, biotechnology and so on.
References to The World