An evaluation of perceptions and implementation of good review practices in the medicine review process at the Egyptian drug authority.

@article{zaki2026evaluation,
  title = {{An evaluation of perceptions and implementation of good review practices in the medicine review process at the Egyptian drug authority.}},
  author = {Ghada Zaki and Sam Salek and Stuart Walker and Sungsoo Chun},
  journal = {Frontiers in medicine},
  year = {2026},
  month = oct,
  doi = {10.3389/fmed.2026.1920714},
  url = {https://europepmc.org/article/MED/42922917},
  note = {CC BY},
}

TY  - JOUR
TI  - An evaluation of perceptions and implementation of good review practices in the medicine review process at the Egyptian drug authority.
AU  - Ghada Zaki
AU  - Sam Salek
AU  - Stuart Walker
AU  - Sungsoo Chun
PY  - 2026
DA  - 2026/10/08
JO  - Frontiers in medicine
DO  - 10.3389/fmed.2026.1920714
UR  - https://europepmc.org/article/MED/42922917
AB  - Introduction  Good Review Practices (GRevPs) are considered of value for regulatory system strengthening that support timely, consistent, transparent, and high-quality regulatory reviews. It is therefore important that GRevPs are continuously updated and monitored to improve the review process. This study is the first assessment of GRevPs within the Egyptian Drug Authority (EDA) and provides a baseline for future monitoring and improvement.Methods  A cross-sectional study was conducted among Marketing Authorisation (MA) assessors within the EDA using a semi-structured questionnaire. It comprised two sections: the validated Good Review Practices (GRevPs) questionnaire developed by the Centre for Innovation in Regulatory Science (CIRS), which assessed knowledge, attitudes, practices and barriers to GRevPs adoption; and a study-specific section assessing the perceived importance and implementation of review-quality activities. Descriptive statistics summarised the data, while a gap analysis using mean differences and an Importance-Performance Analysis (IPA) matrix identified priority areas for improvement. Open-ended responses were analysed using conventional content analysis.Results  Fifty-five of the 80 assessors approached completed the questionnaire (69%). Within the MA departments, respondents reported comparable levels of full and partial adoption of GRevPs (44% and 53%, respectively). Assessors demonstrated a good understanding of GRevPs and identified efficiency, consistency, reduced duplication, and error minimisation as key benefits. Gap analysis showed that review-quality activities were recognised as important, with positive practices and attitudes toward GRevPs. However, areas requiring further improvement included continuous, practice-oriented training; proactive communication with applicants; adherence to timelines; cross-team coordination; consistent recording and updating of review information; and mechanisms for acting on applicant feedback. High workload, limited staffing capacity, time pressure, and communication challenges were identified as the main barriers to implementation.Discussion  These findings indicate that EDA has established a strong foundation for implementing GRevPs, supported by documented procedures, review tools, and assessors' understanding. However, greater attention is needed to ensure consistent implementation, monitoring, and continuous improvement of GRevPs, particularly through ongoing practical training, digitalisation, external tracking mechanisms, and adequate resource allocation. As the Egyptian Drug Authority (EDA) progresses towards Maturity Level 4 and WHO-Listed Authority aspirations, understanding how GRevPs are perceived and implemented in practice becomes increasingly important.
SN  - 2296-858X
ER  -