Implementation of mandatory eCTD format for regulatory submissions

News Category: Regulatory news

Date: 03/04/2017

Towards the end of 2018, all human medicines (including herbal and homeopathic) applications must be submitted in electronic common technical document (eCTD) format. Alongside other European Competent Authorities, the HPRA intends to make this change mandatory in line with the eSubmission Roadmap. See also the eSubmission Roadmap Timeline

In addition, the HPRA has also decided to continue to follow the eCTD guidance where it states that it is not a requirement to submit an eCTD baseline but is recommended. It should be noted that if required, the HPRA can request additional information or a baseline submission at any time. 

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