Reliance Mechanism In Regulatory Processes "DRAP Approach on Good Reliance Practice".
This document aims to provide policy guidance to define criteria, procedures, and mechanisms for reliance pathways to facilitate regulatory decisions by giving significant weightage to the assessments performed by other National Regulatory Authorities or trusted institutions as a reference for various decision-making processes in regulatory functions performed by DRAP.
Guidance on Clinical Trails Applications.
This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP).
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