CRED Practical Document Writing and Management

Where we are now

eCTD is the mandatory electronic format for: - (Current eCTD v3.2.2, with use of eCTD v4.0 proposed for Q3 of 2020 for CP submissions)

● EMA (Centralised Procedure) since January 2010 ● European procedures (DCP/MRP) since January 2018

● NCAs – All new MAA in the National Procedure (NP) since 1 July 2018 ● NCAs – All regulatory activity in the National Procedure by 1 January 2019

Others… ● US FDA - mandatory for NDAs, ANDAs & BLAs, with INDs & Master Files since May 2018 ● Health Canada - mandatory since Jan 2018 for NDS, SNDS, ANDS, SANDS ● eCTD accepted in Switzerland / Japan / China / Saudi Arabia / Oman / Thailand / Australia / South Africa