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On August 3, 2017, the committee of the Eurasian Economic Union (EAEU) published the standards for electronic submissions of drug applications. With respect to same, the Board of the Eurasian Economic Union released two important ‘Decisions’ on the electronic submission format, which mandates the applicants to provide more detailed information. What are these ‘Decisions’ and guidelines related to them? Take a look:
- Decision 78 – Decision 78 focuses on providing details and clarification on the content and structure of the submissions. As per the decision, existing applicants are also required to re-structure their applications and make a few Regulatory changes to their submissions due to the change in modules and section structures. From December 31, 2020, new applicants will no longer be able to file applications as National Procedure. The applications can only be submitted by Decentralized Procedure (DP) or Mutual Recognition Procedure (MRP).
- Decision 79 – Decision 79 emphasizes the technical compliance of the electronic submissions. As per the decision, the new electronic format will require additional XML files apart from the PDF documents submitted for the drug application. The application will require two specific types of XML files:
1. R.017 – Containing information about the applicant company, the product, and the substances.
2. R.022 – Containing information about the documents submitted along with each document type’s specific identifiers.
The new electronic submission format was introduced by the EAEU committee to strengthen the review process of drug applications in the region. In that perspective, the quality of the documents stands as an essential part of the submission dossiers. In order to improve the search of the documents, all the PDF files are required to be OCR processed. Applicants must also ensure that no corrupt PDF files are submitted to the health authority and the files are not password protected. The maximum file size allowed for any document is 100MB.
Compliance Timelines
From December 31, 2020, it is mandatory for New Marketing Authorizations to comply with the new electronic submission requirements. Additionally, any follow-up submissions should align with the new format from December 31, 2025.
For drug applications that are already submitted and approved by any of the EAEU member states, applicants must start updating the applications as per the new format by the end of the given mandatory deadline. Whereas, new applicants planning to enter the EAEU region can start preparing the applications in the electronic format. Thus, to ensure successful market-entry in EAEU region, it is advised to prepare submissions in eCTD format. Chose the eCTD software that suits your submission requirements. Stay up to date. Stay compliant.
