Mandatory use of eCTD format in EU procedures

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018

November 10, 2017

Do you have a medicinal product registered in Europe? Please be aware that eCTD will become the mandatory standard for submission for maintenance activities!

The eCTD roadmap has been updated to focus on the mandatory use of eCTD. These are the dates for the different procedures:

January 2018: All MRP submissions (human)
July 2018: new MAA in NP (human)
January 2019: All submissions (human) in CP, DCP, MRP and NP

Asphalion has over 10 years of experience with eSubmissions and support all EU procedure types (CP, MRP/DCP and NP).

If you need any support for eCTD publishing and/or baseline preparation, contact us at [email protected]

For more information: http://bit.ly/2zqqHb3

Search News & Events

Brexit updates for human use medicinal products approved via MRP/DCP

December 21, 2020

As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.

Javier Febrero Alija – New Regulatory Information Manager

December 17, 2020

Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.

Season’s Greetings

December 17, 2020

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

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Mandatory use of eCTD format in EU procedures

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018

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Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

About

Team

Partners

CSR

Careers

Mandatory use of eCTD format in EU procedures

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018

Search

Filter by category

Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

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