Pharmacogenomics information for registered medicines in Zimbabwe: Systematic review of approved Summary of Product Characteristics

Description

Analytical review of the Summary of Product Characteristics for drug with a Dutch Pharmacogeenetics Working Group (DPWG) Testing recommendation registered in Zimbabwe as of 1 February 2026. The SmPCs were systematically reviewed for pharmacogenomic information content and scored according to DPWG criteria fpr SmPC PGx information for clinical implication scoring. This is a pilot project of the Consortium for Genomics and Therapeutics in Africa (CGTA) to assess regulatory approved drug information.

Steps to reproduce

Determination of Medicines with Actionable Pharmacogenomic Biomarkers in Zimbabwe • Extract medicines listed in the EDLIZ 9th edition (2025), excluding those classified as therapeutic foods, blood and blood-derived products, dermatological agents, immunologicals, vaccines, ophthalmic preparations, dialysis solutions, electrolyte correction solutions, vitamin supplements, reproductive health items, other medical devices, local otorhinolaryngology, and dental preparations. • Review the compiled list to identify medicines with testing recommendations according to the Dutch Pharmacogenetics Working Group (DPWG) guidelines (accessed 10 January 2026). • For each eligible gene–drug pair, document the corresponding genotype/phenotype. Assessment of Pharmacogenomic Information in SmPCs • For each essential medicine identified with an actionable pharmacogenomic biomarker, download all approved drug SmPCs from registered brands via the Medicines Control Authority of Zimbabwe (MCAZ) website (https://smpcs.mcaz.co.zw/). • Systematically review all SmPCs and evaluate them based on the fourth criterion of the DPWG Clinical Implication Score (CIS) framework. • Extract the exact phrase used for scoring from the SmPC, and have a second reviewer analyse and reach consensus on the scoring applied. • Assign the CIS score using the highest scoring SmPC brand as the national benchmark. • Conduct an independent dual review; resolve any discrepancies through consensus to ensure reliability. Extract the exact phrase used for scoring from the SmPC and engage a second reviewer for analysis and consensus scoring.

Institutions

• African Institute of Biomedical Science and Technology

  Harare, Harare
• University of Zimbabwe

  Harare, Harare

Categories

Funders

• American Association For Cancer Research

  Pennsylvania, Philadelphia

  Grant ID: 24-15-75-MAZH

Licence