The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the release of the second edition of the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS“.
These guidelines provide a comprehensive framework for all stakeholders involved in clinical research related to therapeutic goods in Pakistan.
Key Features of the Updated Guidelines:
- Enhanced Clarity: This second edition streamlines the guidance, making it easier for sponsors, investigators, research institutions, and laboratories to understand the procedures for GCP inspections.
- Broader Applicability: The guidelines now explicitly cover Contract Research Organizations (CROs), BA/BE Study Centers, and Bio-Analytical Laboratories involved in clinical trials.
- Improved Transparency: The revised document clearly outlines the roles and responsibilities of both clinical research participants and DRAP inspectors during the inspection process.
- Risk based GCP Inspections
Benefits of Following these Guidelines:
- Ensuring Patient Safety: Adherence to GCP principles is critical for safeguarding the well-being of participants in clinical trials.
- Promoting Research Quality: Clear communication of inspection procedures fosters a transparent and high-quality research environment.
- Facilitating Regulatory Compliance: Understanding inspection protocols allows research entities to prepare effectively and demonstrate compliance with DRAP regulations.
We encourage all parties involved in conducting clinical research in Pakistan to download and familiarize themselves with these updated guidelines.
Download the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS”