Module 1 2021

25/06/2021

Electronic submissions: Region by region – EU (2)

• The Centralised Procedure ─ The eCTD has been mandatory since March 2014 ─ The use of the EMA Gateway has also been mandated ─ The EMA has invested in providing the tools to review the eCTD to all EU National Competent Authorities (NCAs) ─ Submission to the Rapporteur, Co-Rapporteur and CHMP members in the NCAs is also easy • Submit your eCTD just once to the EMA and it will be validated and uploaded to the Central Repository • All of the NCAs will collect their copy of the submission from the Central Repository

The Organisation for Professionals in Regulatory Affairs

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Electronic submissions: Region by region – EU (3)

• The Mutual Recognition and Decentralised Procedures ─ For all new submissions in MRP and DCP, the mandatory use of eCTD has been in force since January 2018, and for all new national submissions, since January 2019. ─ There is specific guidance on how to use the eCTD in these procedures

The Organisation for Professionals in Regulatory Affairs

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