Building Capacity to Assess Bioequivalence Studies for MNCH Medicines in Mozambique
The process of product registration or marketing authorization is a key regulatory function of a national medicines regulatory authority (NMRA) to ensure the safety, quality, and efficacy of medical products on the market. A country’s NMRA must assess product dossiers to determine if the product warrants marketing authorization for import, distribution, or sale.
Most medicines for maternal, newborn, and child health (MNCH) are available as oral generic formulations. Oral generic medicines have to be compared to the comparator or innovator product to assess their bioequivalence (BE) to ensure therapeutic equivalence. Fully functional NMRAs must have the capacity to conduct BE assessment studies to ensure the quality and efficacy of all oral medicines, including those used for MNCH.