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Guidance on Eligibility Criteria for Priority Medicinal Products Through Continental Assessments

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Guidance on Eligibility Criteria for Priority Medicinal Products Through Continental Assessments Orientations sur les critères d’éligibilité pour les médicaments prioritaires par le biais d’évaluations continentales

Priority medicinal products for continental assessment are medicines that will be assessed under the Evaluation of Medicinal Products Technical Committee (EMP-TC) and that require regulatory expertise not currently available in most countries or for which expertise is limited under Medicines Regulatory Harmonization (MRH) projects at Regional Economic Community (REC) level. Priority products may also be medicines needed across the continent but often in small volumes in each country to incentivise manufacturers to apply for registration at country level or even for joint assessments at regional level. They are also medicines needed under special circumstances, such as continental, regional or national public health emergencies. 

To assess priority medicines, EMP-TC will work with a pool of assessors from African NRAs but will also benefit at the start from support from international regulatory experts. The objective is to build the capacity of regulatory experts on the continent progressively. 

Product recommendations from the EMP-TC are envisaged to lead to rapid national registration by the 55 National Regulatory Authorities based on the assessment report produced by the EMP-TC using a reliance model in alignment with continental reliance frameworks. Therefore, the EMP-TC assessment process should be strong enough to guarantee the quality of the assessments done at continental level, to avoid duplication of efforts by NRAs and RECs and to attract manufacturers to apply using this pathway.