echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Talking about: the matters of CTD (1)

    Talking about: the matters of CTD (1)

    • Last Update: 2018-04-26
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: for drug research and development, especially for chemical drugs, no matter innovation or imitation, the final application can not be separated from CTD data Once upon a time, many drug R & D and registration personnel only understood CTD as a simple application document format requirement In fact, what CTD gave was a research and development idea, more a drug quality control idea combining process control and end-point control, more an important embodiment of today's well-known QBD idea, and a department of drug research content and research level Unified technical requirements CTD in the global environment in 1989, in order to harmonize the differences of human drug registration technology and make the same drug registration document can be applied in many countries simultaneously, the three parties held an international conference of National Drug Administration in Paris and began to formulate specific implementation plans Since then, the registration departments of European, American and Japanese governments have contacted the International Federation of pharmaceutical industry associations (IFPMA) to discuss the possibility of international coordination meetings jointly sponsored by registration departments and industry departments In April 1990, an international conference was held in Brussels with the participation of three registration departments and industrial departments to discuss the significance and tasks of ICH, and the ICH Steering Committee was established Quality (q), safety (s) and effectiveness (E) are the three aspects that the ICH steering committee uses to formulate various technical requirements as the basis for the approval of drugs for marketing In order to make the form and content of new drug declaration consistent, a general technical document (CTD) has been formulated, which is divided into CTD, ctd-q, ctd-s, ctd-e and ectd This unified document template has laid the foundation for multi-country synchronous declaration and gradually improved in continuous use Today, CTD has developed In the European Union, the United States, Japan, Canada, Switzerland and other countries, it is optional or compulsory to declare drugs in the form of CTD registration Many official registration agencies in other countries and regions have also adopted the form of CTD declaration, and have made changes according to local requirements, such as Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, etc of ASEAN countries Eden, the Philippines, Singapore, Thailand and Vietnam have issued the asenctd format registration document requirements, referred to as ACTD This shows that more and more countries agree with the concept of ICH and accept the declaration data in CTD format For China's CTD content, see below Table 1 the development history of ICH M4 CTD, the complete set of 5 modules of ich-ctd, the complete set of registration documents determined by ICH Steering Committee are divided into 5 modules, module 1 as a single document has regional specificity, and the other 4 modules are CTD format documents, which are generally used as the compilation format of international registration documents Figure 1 The structure diagram of CTD file format ich-ctd standardizes the format and content of drug registration application The five modules complement each other From pharmaceutical research to clinical trials, registration reviewers can understand the whole process of drug research and development success through a full set of CTD files, which provides a strong guarantee for approving drug listing If a product is researched and developed according to the requirements of ICH, the same set of ich-ctd registration documents are used to simultaneously declare for quasi listing in many countries, that is to say, the products produced on the same production line can be listed and sold in many countries, and the declaring enterprise can save a lot of human, material and financial resources through this way The development of CTD in China since the promulgation of drug administration law in 1984, it is required that new drugs applying for registration must submit materials In the process of drug registration, China has gradually formed a drug registration document model with Chinese characteristics Especially in 2001, after China's official accession to the world trade organization, China has been constantly optimizing the workflow and methods of drug registration, and actively integrating with the international advanced level Therefore, ten years later, in September 2010, China's drug evaluation center CDE, referring to the internationally accepted technical document CTD, organized the drafting of the CTD document format for the application for pharmaceutical registration of domestic chemical generic drugs, including the requirements for the submission of CTD format application materials and the summary of main research information, officially issued the requirements for the preparation of chemical CTD format application materials, and in accordance with the CTD format Technical review shall be carried out The formal implementation of this set of documents marks a new step of drug registration in China At that time, the requirements for the preparation of CTD format declaration materials of chemical drugs issued in 2010 was mainly applicable to the pharmaceutical part declaration materials of production registration applications of chemical drugs registration classification 3, 4, 5 and 6 in Annex 2 of the measures for the administration of drug registration, i.e the quality related overview of CTD format module 2 and the quality related documents of module 3 Note that at that time, new drugs of category 1 and category 2 were It's not involved In order to further optimize the normalization and unification of CTD data, in July 2011, CDE released the CTD format electronic document standard (Trial) for chemical and pharmaceutical data to unify the content of document font, font size, line spacing, page setting and document structure catalog In addition, as an incentive policy, in September 2012, CFDA issued the relevant instructions on the independent and orderly review of varieties declared in accordance with the CTD format, encouraging the products that are the first to declare in accordance with the CTD format in China to enjoy the advantages of independent queuing and enter the priority review channel After many years, when CTD has gradually become the daily work content of drug audit, in November 2015, CFDA issued the notice on Soliciting Opinions on the requirements for the preparation of CTD format application materials of chemical generic drugs, soliciting opinions on the revised draft of the requirements for the preparation of CTD format application materials under the situation of the original chemical registration classification 6, and mainly revised the API and the Part of the preparation requirements, and added the content of the bioequivalence test of generic drugs In March 2016, CFDA issued the announcement on the work plan for the reform of chemical drug registration and classification and its interpretation, and formulated new requirements for chemical drug registration and classification; in order to support the new registration and classification plan of chemical drugs, in May of the same year, CFDA then issued new requirements for the trial use of chemical drug application materials, among which, the pharmaceutical materials of new drugs and generic drugs are required to be written in the form of CTD , the non clinical and clinical part of generic drug documents also introduced the setting of CTD chapter, which declared that CTD format document officially became the chemical drug declaration and registration format, and entered the milestone of CTD development (Note: the official website is being improved, and the content of the form can be copied and pasted to find the relevant content.) the content and characteristics of CTD issued by China's drug regulatory authorities The formal declaration materials of chemical drug CTD format issued in China include two parts: the main research information summary form and the body of the declaration materials, respectively corresponding to module 2 and module 3 of ich-ctd Template 2 of CTD format issued by CFDA is 2.3 P summary of main research information The API part mainly includes 7 chapters: basic information, production information, characteristic identification, quality control, reference, packaging materials and containers, stability, etc The preparation part mainly consists of 7 chapters: dosage form and product composition, product development, production information, raw and auxiliary material control, preparation quality control, reference material, stability, etc the difference between the international CTD template and the international CTD template is that the preparation packaging material and container are missing, and the relevant content is a separate section in the international CTD template, while the content of China's CTD template is in product development Described in section The information in the main research information summary table is an overview and important content extraction of the information in the main parts of module 3.2 P all contents and data shall be consistent with the application data, and information, data or conclusions not involved in module 3 or other parts of CTD cannot be written, and where there is a need for detailed data support, please refer to module 3.2 P The format, catalogue and item number of the corresponding application materials shall not be changed The main research information summary table should be systematic, comprehensive and focused, and make an objective and comprehensive evaluation on the stability and controllability of drug quality Module 3.2 P includes 7 chapters, including all contents of pharmaceutical declaration See http://www.cde.org.cn/download.do? Method = list & class \ Id1 = 1 Figure 2 summary of CTD template download related to national CDE First of all, this article is more about a brief introduction to the CTD documents that must be used in the current drug research and development, so that the peers who have not participated in the CTD document writing can have a simple understanding of this Secondly, although the author has participated in the compilation of CTD data, he is more responsible for the summary of API information, while the former summary is more about the rearrangement of data The original research and development ideas did not follow the CTD format and QBD concept to design and implement With the continuous study on the path of pharmacy, the author understands the rigor of drug research and development and the internal guidance of CTD data Therefore, the relevant content of CTD is summarized in the hope that peers can encourage each other and forge ahead.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.