eCTD and NeeS standards

Since 1 June 2010, Fimea has received marketing authorisation materials in the electronic eCTD, NeeS or VNeeS format. Fimea strongly recommends that applicants transfer to eCTD applications for human medicines as quickly as possible. The EMA schedule for making eCTD applications mandatory is available on the EMA website (Telematics Strategy Implementation Roadmap, PDF)

eCTD (electronic Common Technical Documentation)

eCTD is a standard developed by the ICH (International Conference of Harmonisation) for the processing of marketing authorisation applications for human medicines. In addition to the EU, eCTD is used in USA, Canada and Japan.

The structure of the documentation associated with a medicinal product follows the modular division (M1-M5) defined in the CTD. The module containing administrative information (M1) is region-specific. In the EU, Module 1 is maintained by the Change Management Board for electronic submissions of the pharmacovigilance network.

The development of the next major version of the eCTD standard is integrated as part of the HL7 ISO standardisation work, which will further strengthen the position of the eCTD as a standard for the electronic processing of marketing authorisations between the industry and the authorities.

The eCTD application uses XML metadata for managing the lifecycle of the applications for medicinal products. The invariability of the document contents is ensured by an MD5 checksum added to the document descriptions Several commercial software packages exists for processing the eCTD applications. Fimea uses the Eurs Is Yours application selected by EMA. For the applicants, there is software for validating (i.e. ensuring the technical correctness) the applications before submitting them to the authorities.

NeeS (Non-eCTD electronic Submissions)

Electronic marketing authorisations for human medicines can also be created in NeeS format. However, NeeS is not an official standard. NeeS applications are required to follow the CTD document structure. The EU Telematic Implementation Group (TIGes) has published a NeeS guideline for the applicants.

Fimea will only approve those electronic applications that meet the EU NeeS validation criteria.

Further information

  • Hartikka Jaakko
    ICT-Manager tel. +358295223619