The MHRA has issued guidance regarding the use of non-clinical data generated outside the OECD Mutual Acceptance of Data (MAD) framework in support of UK Clinical Trial Authorisation applications. This guidance is significant as it outlines how such data can be utilized in the regulatory process for clinical trials in the UK.
This development may impact manufacturers and sponsors by providing clarity on the acceptance of non-OECD data, potentially broadening the scope of data that can be submitted for trial authorizations. It could facilitate the inclusion of diverse data sources, which may enhance the robustness of clinical trial applications.
Source: gov.uk · Image: Figure 1 Food and Drug Administration’s (FDA) Typical Drug Development and Approval Process (35856478702) by U.S. Government Accountability Office from Washington, DC, United States, Public domain, via Wikimedia Commons
Use the database as your supply chain compass →
