How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Policy 0070 is a ground-breaking initiative and the European Medicines Agency (EMA) represents the first agency on a global level that will grant access to clinical trial data on such a large scale. With the requirements for all non-Covid products expected to restart in 2023, there is preparation required for qualifying submissions – which include new marketing authorization applications (MAAs) and clinical variations.