# Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority

## TL;DR

This study evaluates how well Zambia's medicines regulatory authority follows good review practices and identifies areas for improvement.

## Contribution

The study provides an assessment of GRevP implementation in ZAMRA and highlights opportunities for enhancing regulatory performance.

## Key findings

- Only 42% of assessors reported full adoption of GRevPs across the agency.
- Training on incorporating GRevPs into daily work was seen as valuable by participants.
- Target timelines for review processes were not consistently followed at the agency level.

## Abstract

The implementation of Good Review Practices (GRevPs) ensures the timely, high-quality review and enhanced availability to safe, quality, and efficacious medicines. It is important, therefore, that all aspects of GRevPs are continuously updated and monitored to promote improvement of the review process.

This study aimed to assess the implementation of the GRevPs in the Zambia Medicines Regulatory Authority (ZAMRA) to identify opportunities for improvement. The GRevP Questionnaire developed by the Centre for Innovation in Regulatory Science (CIRS), an established, structured and multi-dimensional questionnaire was completed by the scientific reviewers of the ZAMRA.

Twelve of the 16 assessors took part in the study of whom 5 (42%) reported that GRevPs have been implemented and fully adopted across the agency. 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, to improve process predictability and increase 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 the participants reported that ZAMRA has a consistent method for documenting those practices that need to be improved by GRevPs. A mechanism to facilitate updating GrevP at ZAMRA is currently in place, however, it requires enhancement. In general, the importance of GRevPs was well understood by the assessors, however the study showed that target timelines were not well followed at both the department and agency levels.

This study has successfully determined the GRevPs used in the review process and their implementation by ZAMRA. It has provided a reference point from which the ZAMRA can work towards improvement as a means to enhance regulatory performance. The findings of this study will form the basis of development for the NRA as it strives to achieve the WHO Maturity Level 3 status.