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)
Variations and renewals
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
Integrated & Thorough – connecting preclinical, clinical, and quality data
Critical Thinking & Documentation – well-reasoned conclusions that withstand scrutiny
Project & Quality Management – structured review plans with clear timelines

Managing the Review Process

1. Project Management

Planning and monitoring review activities
Tracking progress against timelines
Assigning clear roles to reviewers, team leaders, and QA experts

2. 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

3. 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
Public: Transparent publication of decisions and regulatory processes to build trust

Reviewer Expertise & Critical Thinking

EDA emphasizes:

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:

Public health priorities
Reliance on trusted regulatory decisions (e.g., SRA approvals, WHO procedures)
Efficient benefit–risk assessment and documentation
Why This Matters for Regulatory Professionals

For regulatory affairs teams, this guideline is both a compliance requirement and a strategic opportunity:

Align submissions with EDA expectations to avoid delays
Use EDA’s templates and checklists to ensure dossier completeness
Prepare for risk-based reviews and potential post-approval commitments
Engage proactively with EDA during review to address questions quickly

Final Thoughts

The updated GRevP guideline represents a significant step toward global regulatory convergence and faster patient access to innovative therapies in Egypt.
Regulatory professionals should carefully study this guideline, integrate its principles into their internal SOPs, and train teams on EDA’s expectations. Doing so will improve dossier quality, minimize review cycles, and strengthen compliance with Egypt’s evolving regulatory framework.