Sample Regulatory Assessment for Treatment Access Program

The WEP Regulatory team has created this resource to highlight the heterogenous regulatory landscape across treatment access programs including Expanded Access Programs (EAPs), Compassionate Use Programs, and Named Patient Programs.

The resource lists a regulatory assessment for 14 countries around the world for a hypothetical access program for a globally unlicensed medicinal product still in clinical development stage. Please complete the form to the right to download.