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P107: Assessment of Compliance with Good Review Practices by Scientific Reviewers within the Zambia Medicines Regulatory Authority

Poster Presenter

Constance Sakala Chisha

PhD Student
University of the Witwatersrand
South Africa

Objectives

To identify the current perspective of Zambia Medicines Regulatory Authority (ZAMRA) in the use of Good Review Practices (GRevPs) and provide a baseline on the reviewers’ knowledge, attitudes, and practices, as well as identify barriers and areas for improvement.

Method

The structured Good Review Practices questionnaire for Regulatory Agencies was completed by scientific reviewers of ZAMRA. It characterizes how GRevPs are developed, implemented, and refined so as establish the reviewers’ level of knowledge, attitude, and practices.

Results

Twelve of the 17 scientific reviewers employed by ZAMRA took part in the study. Five (5) reviewers (42%) reported that GRevPs have been implemented and fully adopted across the authority. All of the 12 study participants believed that GRevPs are being implemented by the Authority either formally or informally. When asked to what extent they felt GRevPs are in development at ZAMRA, a total of five (5) reviewers indicated that GRevPs have been developed and fully adopted in the department’s daily practice. Three (3) other reviewers indicated that the best practices for key areas were in the process of being developed. Three (3) reviewers indicated that the good review practices have been developed but not yet adopted in the department’s daily practice. Additionally, two (2) reviewers indicated that GRevPs have been developed but have not yet been adopted in the department’s daily practice. The study participants provided details indicating the reasons why they believe quality measures had been implemented within ZAMRA. The three most common reasons were to be more efficient, ensure consistency and transparency. However, most of the respondents believed that the current GRevPs framework could be improved. The study noted that training on how GRevPs are to be used and incorporated into daily work was deemed valuable. All study participants reported that ZAMRA has a consistent method for documenting practices that need to be improved by GRevPs, as well as that a mechanism had been established to facilitate the updating of the GRevPs. In general, the importance of GRevPs was well understood by the reviewers, however the study showed that target timelines were not well followed at both the department and agency levels. Most of the respondents believe that the development of GRevP should improve the quality and timelines of the review, efficiency of the review through standardization, consistency of the review, transparency, and clarity throughout the review.

Conclusion

This study assessed the level of knowledge, practice, and attitude that scientific reviewers have and the implementation of Good Review Practices within ZAMRA. These results indicated the different levels of understanding relating to GRevPs by scientific reviewers. It was observed that the Authority was implementing some elements of GRevPs, while other areas, such as transparency, and communication, as well as conducting on-the-job training and mentoring the reviewers on the principles of GRevPs require improvement. Implementation of all the elements of the GRevPs will significantly improve the quality of the review process, thereby ensuring timely accessibility of quality medicines for patients. This study forms the starting point for future assessment and continuous improvement of the review process by ZAMRA, an important practice of a well-functioning regulatory system as it strives to attain WHO ML3 status. The following recommendations result from this study: • Improve the knowledge base on GRevPs for reviewers through in-house training and orientations. • Strengthen adherence to published target timelines by enforcing consistent monitoring across all application types. • Enhance patient associations as well as feedback from manufacturers in the regulatory review process. • Incorporate structured frameworks for decision-making and benefit-risk assessment in the review process to improve consistency and transparency. • Enhance transparency and communication through publishing summaries of the assessment reports for approved medicines.