The Phase I Unit inspection process is designed to ensure that these units meet high standards for preventing harm to clinical trial subjects and managing medical emergencies effectively. Beyond adhering to basic GCP requirements, units listed under the NPRA Phase I Program must implement additional best practices that uphold the highest standards for participant safety and emergency response.

This program provides assurance to sponsors that accredited units listed can significantly enhance volunteer safety and are recognized as centers of excellence for Phase I research. Phase I Units that comply with the Malaysian Guideline for Good Clinical Practice, the Malaysian Guideline for Phase I Unit Inspection and Accreditation Program, and all applicable regulatory requirements will be listed in the “National Pharmaceutical Regulatory Agency Phase I Unit Inspection and Accreditation Program.”