On 3rd August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions. What will be the impact on applicants that would like to register a new drug in the EAEU? Is it the same as the ICH eCTD, only with a new regional module M1? What are the guidelines that need to be followed?
The Board of the Eurasian Economic Union has published decisions on the electronic submission of drug applications. These include decisions 78 and 79 of the board.
Decision 78 gives details and clarifications on content & structure of the submissions. For existing applicants, this will involve changes in regulatory requirements. Due to the change of the modules / sections structure, existing applications will have to be re-structured to adapt the new structure and to comply with the current requirements. In general, the whole application procedure will change. From 31st December 2020, applicants will no longer be able to submit new applications as a national procedure, it will be replaced by either Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP)
Decision 79 of the board gives details on technical compliance of the electronic submissions. Additional XML files need to be provided alongside with the PDF documents for a drug application. The XML for the application form is known as “R.017” which contains information on the applicant company, the product, and the substance. A second XML “R.022” contains information on the documents submitted, together with specific identifiers for each document type.
Document quality is essential, and all scanned PDFs need to be OCR processed in order to be searchable. No corrupt PDF files should be submitted. Password protection is also not advised in order to allow the reviewers to open the documents. There is a maximum file size restriction of 100MB for the documents.
Timelines for submitting in the new electronic format to the EAEU were published as follows:
New marketing authorizations in the EAEU have to be compliant with the new, electronic submission format from 31st of December 2020 onwards. Follow-up submissions are mandatory to be submitted in the electronic format from 31st December 2025.
What does this mean for the applicant? What are the to-dos?
For all your existing applications, already approved in one of the EAEU member states, you should start getting prepared for the transition to the electronic format by:
- updating the content and structure of your application to be compliant with decision 78
- making documents electronic by scanning / OCR processing or creating new ones
- additionally, it is advised that you submit a baseline submission of your existing dossier in electronic form
If you don’t have an existing, approved application already within one of the EAEU member states, you are now able to start your application directly in the electronic format.
5 modules use XML files for metadata - so, is it eCTD?
The submission format to the EAEU is not a regional implementation of the existing ICH eCTD standard, as seen in Europe, USA, Canada or Australia implementations. It does have some similarities with eCTD submissions, especially when it comes to structuring and modules. Instead, the EAEU submission format has its own, quite advanced but different XML format to submit additional data on application, documents and lifecycles. This also clearly separates it from NeeS - the predecessor of eCTD. Sometimes you might hear it being referenced to as the “eCTD for Eurasian Economic Union / EAEU” - but don’t get confused by this, as technically it is a new and independent standard of its own, not related to established eCTD standard.
Whether you’re based in the EAEU or anywhere else in the world, if you’re looking to submit electronic submissions in the EAEU, then EXTEDO has the technology and expertise you need. Reach out to us today.