Digest: February 2022 Featured news that matters in medical writing and communications

EMA News

Updates on the EMA pre-authorization procedural advice for users of the centralized procedure have been made in 2021. Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication.

The document can be accessed at:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure-document_en.pdf.

Real-world data (RWD) and real-world evidence (RWE) are already used in the regulation of the development, authorization, and supervision of medicines in the European Union. In 2021, EMA published their vision for the use of RWE in medicines regulation in the EU. It can be accessed at: https://www.ema.europa.eu/en/news/vision-use-real-world-evidence-eu-medicines-regulation.

CTIS News

New and revised training and supporting materials for the Clinical Trials Information System (CTIS) are available at: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support#reference-materials-for-clinical-trial-sponsors-section. The training programme is divided into learning modules targeted for the different user groups involved in CTIS.