Evaluation of the Quality Decision-Making Practices Utilized by the Zambia Medicines Regulatory Authority Technical...

A consistent and transparent approach is essential for quality decision-making in the review and approval of medicines. This is achieved through the use of a standard and well-defined framework, as the decisions made should not be influenced by any biases. While most National Medicines Regulatory Authorities (NMRAs) have designed frameworks to assess the quality of their decisions, many have not been implemented. A well-structured framework improves consistency and predictability in the decision-making process. The Quality of Decision-Making Orientation Scheme (QoDoS) has been widely adopted as a leading framework for this purpose. This study aimed to assess the decision-making processes of two technical committees operating within the Zambia Medicines Regulatory Authority (ZAMRA) using the QoDoS framework developed by the Centre for Innovation in Regulatory Science (CIRS); determine areas of improvement for routine assessment of quality of decision-making and its acceptability with respect to ZAMRA; and suggest ways of improving the lowest-scoring Quality Decision-Making Practices (QDMPs) and how these may be implemented into the decision-making framework to ensure consistency.

The framework was used to assess the quality of the decision-making process and subsequent implementation of the ten QDMPs. The study included five members from the Technical Committee for Human Medicines (TCHM) and seven members from the Technical Committee for Veterinary Medicines (TCVM) at ZAMRA, all responsible for recommending the approval or rejection of applications following scientific review. The validated QoDoS questionnaire was electronically distributed to the members, and data were analysed using descriptive statistics.

Analysis of the QDMPs across the 12 committee members indicated that both human and veterinary medicines technical committees generally perceived their individual and organizational decision-making practices as favourable. Favourable QDMPs 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). However, areas for improvement were identified in QDMP 1 (systematic structured approach), QDMP 3 (decision criteria), QDMP 5 (alternatives) and QDMP 8 (impact analysis) within the TCVM, as well as in QDMP 3 and QDMP 8 within the TCHM.

This study assessed committee members' perceptions of the implementation of QDMPs in the review and approval of medicines. It was demonstrated that most of the best QDMPs were implemented, except for four QDMPs that needed improvement, namely having a systematic structured approach, decision criteria, alternatives and impact analysis.