A new guideline drafted in the EU explains how disease registries can help supplement pre-authorization evidence and provide infrastructure for evidence generation in the post-authorization phase. The guideline also discusses how to best support regulatory decision-making using relevant methodological, legal and operational aspects of registry data. Also included is an annex that covers good practice for increasing the usefulness of registries for regulatory purposes. Read more here.
(Source: Vibha Sharma, Pink Sheet, September 30, 2020)