Chinese medicine trial eCTD era, chemical generic drugs first test the water

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-06-01

May 30, is the last day of the Dragon Boat Festival holiday, but apparently CFDA drug review center staff did not rest, two eCTD (drug electronic technology general technical documents) draft offer in this day, respectively, It is the "General Technical Documents Agency for Pharmaceuticals (draft for soliciting opinions)" and "Guidelines for the declaration of electronic generic technical documents for chemical generic drugs (draft for soliciting opinions)".

This is also the completion of the eCTD process in the implementation of the eCTD process published in the first substantive aspects of the eCTD system, which is the first substantive issue in the implementation of the eCTD process, which is the result of the establishment of the eCTD system at the 27th press conference of the State Council on February 27th and for the end of 2017 to achieve the electronic reporting and review by the new system Move. Drug Administration Center also said that this is to implement the State Council "on the reform of drug medical equipment examination and approval of the views of the system" on the relevant requirements of eCTD, organization of information, pharmacy, pharmacology and toxicology, clinical, statistical and clinical pharmacology and other professional Reviewers to draft the draft, the community has suggestions or amendments to comments can be e-mail feedback.

As a way of submitting information in drug reviews that have been progressively implemented abroad, the implementation of eCTD in China is destined to be a key revolution in the process of drug registration, and it is also the only way to meet international standards. The introduction of the draft is the day when the Chinese drug trial enters the eCTD era becomes clear.

1, what is eCTD?

The so-called eCTD, the abbreviation of Electronic Common Technical Document, is translated into Chinese as a general document on the quality, safety and efficacy of pharmaceuticals. This is a form of information transmission by pharmaceutical companies to drug regulators whose content is required to meet the requirements of the General Technical Documentation (CTD).

In general, eCTD electronic submission process can be divided into three stages, namely, writing, document editing and submission. Applicants should first write all kinds of data, data, experimental data, etc., after the third-party professional editing service outsourcing to the relevant laws and regulations to build eCTD structured documents, and then by the person in charge through the advance establishment of a good electronic transmission channel , The application documents submitted to the drug sector. In the whole process, convenient, efficient, standardized, environmental protection is its main feature, so eCTD (drug electronic technology general technical documents) because of its registration in the drug registration of many advantages in the United States, Japan and other countries drug sector favored The

ECTD is becoming an important trend in global drug registration declarations because of its advantages in creating, transmitting, copying, reviewing, archiving, archiving, and document lifecycle management. Specifically, for applicants, if a product is applied in multiple markets, some of the data can be shared, greatly reducing costs and improving efficiency. For reviewers, eCTD data is reviewed, managed, transmitted, and archived Very convenient, eCTD format is also conducive to various countries and regions of the drug sector review of the exchange of views.

In 2003, the US FDA began trialing eCTD, which required that electronic filing applications should be conducted in the form of eCTD. In the May 2005 guidelines, ANDA, NDA, certain NDI and BLA must also be required in the form of eCTD Submissions, the completion of this guide, the completion of the audit of the DMF must also be submitted in eCTD format. European EMA is also in 2003 began trial eCTD, and from 2010 began to focus on mandatory requirements. Up to now, countries such as Canada, Switzerland, Saudi Arabia, South Africa, Australia, New Zealand and Thailand have been partially adopted or are moving towards eCTD in addition to traditional ICH members such as the United States, Japan and the European Union.

2, when Chinese eCTD is on

Compared with foreign countries, China's eCTD process is undoubtedly much slower, but with the State Council "on the reform of drug medical equipment examination and approval of the views of the system," a clear reference to eCTD and Food and Drug Administration Bishui Quan Secretary in the State Council press conference statement , China's eCTD process has been significantly accelerated.

February 7, 2017, Bi Jingquan Secretary of the State Council press conference at the press conference, which referred to the establishment of eCTD system and strive for the end of 2017 to achieve the new system through the implementation of electronic reporting and review. This is the official first mention of eCTD in public and gives a preliminary timetable.

And the CDE issued by the document is to make eCTD process more clear. The "General Technical Document Structure of Drugs" is divided into five modules, namely, administrative information, summary and review, quality data (pharmacy), non-clinical research report (pharmacology and toxicology), clinical research Report, the specific structure of the information to be clearly defined to help enterprises to declare.

However, due to the editorial production eCTD format files are often more complex, not all enterprises have the ability and energy to complete their products eCTD declaration, in this case, professional third-party eCTD outsourcing service providers will usher in the development of spring, Such outsourcing companies will be a priority for small, small-scale producers that declare products, or to declare large multinational pharmaceutical companies.