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Software for generating eCTD in the EAEU

10/28/2019 | EAEU, drug registration

The software for the formation of an electronic common technical document (eCTD) in accordance with the rules and requirements of the EAEU will be discussed with specific examples as part of the scientific and practical conference RegLek-2019, which will be held on November 18-20, 2019 in Moscow (Holiday Inn Moscow Sokolniki hotel).

Currently, less than 1% of the dossier has been filed in the Russian Federation to bring it into compliance with the rules of the EAEU, despite the fact that the acceptance of documents began in April.

The relevance of the problem of switching to the filing format adopted in the EAEU is due to the tight deadlines for transitional periods. From January 1, 2021, the registration of new drugs will be carried out only according to the EAEU procedure, and from January 1, 2026 the validity of registration certificates issued under the national procedure will be canceled.

To submit drug registration dossier in accordance with the requirements and rules of the EAEU, applicants must independently create an electronic general technical document.

One of the reasons for such low activity of the applicants is the lack of information on the technical means used to compile dossiers in electronic form.

During the section “The EAEU Single Market for Medicines: Issues and Prospects”, Konstantin Koshechkin, head of the Information Department of the Federal State Budget Institution “National Center for Healthcare and Social Development” of the Ministry of Health of Russia, will show concrete examples of the possibilities of modern means of creating a registration dossier for medicines.

Ekaterina Rychikhina will tell how today to prevent the possible need to undergo a re-registration of medicines after a full transition to work on the regulatory framework of the EAEU and why not drag out bringing the dossier in accordance with the requirements of the Union.

Also on the section:

1. The status of registration and harmonization in the Russian Federation and unjustified risks.
2. Harmonization of legislation - what has been done and what lies ahead?
3. The role of the Expert Committee and its attitude to the regulation of the circulation of medicines.
4. Unified register of the Union: what changes await the national segments.

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