In December 2018 all Clinical Data Publication (CDP) activities were suspended due to the
implementation of the EMA’s business continuity plan (BCP). During the COVID-19 pandemic, CDP activities restarted with a scope restricted to the publication of clinical data submitted in support of regulatory procedures for COVID-19 medicines.
As part of the gradual restart of activities suspended or reduced due to the BCP, in September 2023 EMA will relaunch the publication of clinical data for centrally authorised products beyond the scope of COVID-19 medicines. The following applications will be subject to publication:
• Non-COVID-19 medicines: initial marketing authorisation applications (MAAs) for new active substances (NAS) that receive a positive or negative CHMP opinion in September 2023 and onwards. Withdrawn initial MAAs with a planned opinion date in September 2023 and onwards are also subject to publication.
• COVID-19 medicines: applications in line with the scope defined in Policy 0070 (initial MAAs, extensions of indication and line extensions)…
