Co-creating a process for integrating regulatory approval of late- stage clinical research into the Thailand’s Universal Benefit Package through Action Research
Co-creating a process for integrating regulatory approval of late- stage clinical research into the Thailand’s Universal Benefit Package through Action Research
About Project
The research and development of new medicines is a lengthy and sequential process that spans more than a decade, culminating in regulatory approval based on evidence of quality, safety, and efficacy from clinical trial data. In Thailand, it takes nearly an additional decade for new medicines to be included in the Thailand National List of Essential Medicines (NLEM), further delaying patient access to vital treatments. This project aims to bridge this gap by co-creating a process model with stakeholders so that medicines that are being developed and tested in Thailand can be prepared for NLEM consideration earlier, in parallel with regulatory review, while remaining aligned with acceptable standards for regulatory approval and reimbursement decision-making.