Companies should increase their efforts to address issues and test their electronic Common Technical Document (eCTD) Version 4.0 before it becomes mandatory, according to regulators with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
In the EU, eCTD submissions in Version 4 will become mandatory for all centrally authorized products in 2027. The FDA will require mandatory eCTD submissions in Version 4 by 2029...[RAPS]
