Objectives

To assess the quality of the decision-making process followed by regulatory reviewers, explore their perceptions of the Zambia Medicines Regulatory Authority (ZAMRA) decision-making approach, and evaluate the usefulness of the QoDoS instrument for routine quality decision-making assessments.

Methods

A standardized, validated questionnaire, the Quality of Decision-Making Orientation Scheme (QoDoS), was completed by the members of the ZAMRA Human and Veterinary Technical Committees, responsible for approving medicines.

Results

This study evaluated the utilization of the QoDoS instrument in the assessment of the quality of the decision-making practices in the review process of medicines. The study focused on the decisions made by the members of the technical committees responsible for the approval of medicines. An analysis of the 10-quality decision-making practices (QDMPs), among the 12 technical committee members, showed that both the Human and Veterinary medicine technical committee members perceived their decision-making practices, and those of the organization, as generally favourable for most practices. The members understood that culture does not affect decision-making, although sometimes they use intuition in decision-making, thereby affecting the quality of the decision that has been made. The QDMPs that were considered favourable for both committees included QDMP 2 (Assigning clear roles and responsibilities of the stakeholders involved in the review and approval of medicines), QDMP 4 (Evaluate both internal and external influences or biases), QDMP 6 (Considering uncertainty), QDMP 7 (Re-evaluate new information as it becomes available), QDMP 9, (Ensure transparency and keep a record trail) and QDMP 10 (Effective communication of the basis of the decision). Three of the 10 QDMPs that individual members felt needed improvement include QDMP 1 (Systematic Structured approach), QDMP 3 (Decision Criteria) and QDMP 8 (Impact Analysis) for the Veterinary Technical Committee, while QDMP 3 and QDMP 8 were identified for the technical committee for Human medicines. Almost 70% of the practices were consistent between the Human and Veterinary committee members, however, some differences in the median scores were observed for the QDMP 3, QDMP 5 and QDMP 6. QDMP 3 ranged from unfavourable to needs improvement while QDMP 5 needs improvement and QDMP 6 was determined as favourable for the Veterinary committee.

Conclusion

This study was the first to evaluate and review the quality of decision-making practices made by the two technical committees for Human and Veterinary medicines. To ensure consistency and transparency, it is important to use a standardized framework such as the QoDoS questionnaire that has been used by several companies and regulatory agencies. This will in turn improve trust within the different stakeholders. Using the QoDoS, ZAMRA has demonstrated that they are operating within acceptable standards in as far as the quality decision-making practices are concerned. The Technical committees recognised that the organization is following best practices in the decision-making process with the exception of a few areas that require improvement. From this study it was observed that the QoDoS instrument or framework is beneficial to ZAMRA as it has helped identify its strengths and weaknesses in the area of decision-making in the review and approval process of medicines. The following are the recommendations from this study. The Authority should: 1. Clearly define a framework for the decision-making processes. 2. Conduct decision-making training for the technical committee members so that they are aware of the 10 QDMPs and implement them routinely in those areas that need improvement in the decision-making process. 3. Have formal assessments in place to periodically measure the quality of the decision-making process in the review of medicines. This will improve the practices for both the individuals and the organization. 4. Improve the practices that scored poorly which include impact analysis for both the individual and organizational perspective. Having a defined QoDoS framework in place will strengthen the regulatory review process which is important for ZAMRA as it aims to attain WHO GBT maturity level 3.

This poster by Constance Chisha, Juan Lara, Stuart Walker & Stephanie Leigh was presented at the 2025 DIA Global Annual Meeting, June 2025, Washington DC, USA.

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