EDA Issues Updated Good Review Practice (GRevP) Guideline: What Regulatory Professionals Need to Know The Egyptian Drug Authority (EDA) has released its updated Good Review Practice (GRevP) Guideline, a comprehensive framework designed to enhance the efficiency, consistency, and transparency of product review processes across pharmaceuticals, biologicals, and medical devices. This guideline is adapted from the WHO’s GRevP recommendations and is a crucial step in strengthening regulatory performance in Egypt.
Purpose of the Guideline
EDA’s GRevP Guideline provides high-level guidance on how regulatory reviews should be planned, managed, and documented to ensure:
Timeliness – predictable review timelines for applicants
Transparency – clear communication of requirements and decisions
Consistency – standardized processes across departments
Efficiency & Quality – evidence-based, well-documented decision-making
Scope
The GRevP applies to the review of safety, efficacy, and quality data for:
Marketing Authorization Applications (MAAs)
Medical devices, biological products, and innovative therapies
Key Principles of Good Review
EDA follows ten WHO-endorsed principles to ensure robust, unbiased evaluations:
Balanced & Objective – decisions based on evidence, not bias
Context-Aware – considering product use conditions and public health needs
Evidence-Based – aligning with science and regulatory standards
Problem-Solving & Risk-Based – identifying issues and proposing solutions
Project Management
Planning and monitoring review activities
Tracking progress against timelines
Assigning clear roles to reviewers, team leaders, and QA experts
Quality Management
Applying a continuous improvement cycle: say what you do → do what you say → prove it → improve it
Using SOPs, templates, and checklists to standardize work
Review Stages
Validation: Ensures applications are complete and properly structured before scientific assessment
Scientific Review: Multidisciplinary evaluation of safety, efficacy, and quality data
Communication and Transparency
EDA highlights the importance of clear communication at all levels:
Intra-agency: Collaboration across EDA departments
Interagency: Cooperation with other national and international regulatory authorities
Applicants: Public availability of guidelines, Q&A; documents, and checklists to support high-quality submissions
External Experts: Engagement of academic, clinical, and industry experts for specialized input
Reviewer Expertise & Critical Thinking
Competency and training for reviewers in scientific and regulatory principles
Conflict-of-interest declarations for external experts
Development of critical thinking skills to ensure objective, evidence-based decisions
Strategic and Risk-Based Review
The guideline encourages a risk-based approach, considering:
