Opportunity to submit SEND data packages with new Market Authorisation Applications

From January 2024, EMA is launching a proof-of-concept study to evaluate the added value of using SEND data in the evaluation of new Marketing Authorisation Applications. Applicants are encouraged to submit their SEND data packages, in addition to the eCDT format, as part of their MAA submission. The SEND package must be provided outside the eCTD, inside the working documents folder to avoid eCTD technical validation failure.