Are You Ready for the Upcoming eCTD Requirements in US and EU?

FDA and EMA are requiring eCTD submissions for many application types in the next year.  See the table below for upcoming deadlines in the US and EU.   MMS can help you be ready to meet these requirements through our full set of electronic publishing and submission services.

Agency

Submission Type

eCTD Submission Required as of:

FDA

NDA

May 5, 2017

FDA

IND

May 5, 2018

FDA

DMF

May 5, 2018

EMA

New MAA using mutual recognition procedure

January 1, 2017

EMA

All regulatory activities in EU procedures (DCP/MRP)

January 1, 2018

EMA

New MAA in national procedure (NP)

July 1, 2018

EU

All regulatory activities in national procedures (NP)

January 1, 2019

Sources:

US: https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm153574.htm#Past_Notices 

EMA/EU: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

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