Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades.
Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming. Reducing those procedural burdens to streamline the processes and in order to provide the physicians the flexibility to access investigational drugs and biologics, the US Food and Drug Administration (US FDA), on June 2, 2016 has released 3 final guidance documents.