- The AUDA NEPAD’s Medicines Regulatory Harmonsation Programme would like to inform our esteemed stakeholders and the general public that we have recently developed a draft of the Eligibility Criteria Guidance on Priority Medicinal Products for Continental Assessment through the AMRH Evaluation of Medicinal Products Technical Committee (EMP TC).
- The Guidance lays down the criteria for the priority medicinal products that will be assessed under the Evaluation of Medicinal Products Technical Committee (EMP-TC) that require regulatory expertise not currently available in most countries or for which expertise is limited under Medicines Regulatory Harmonization (MRH) initiatives at Regional Economic Community (REC) level which includes medicines needed across the continent but often in small volumes in each country to give enough incentives to manufacturers to apply for registration at country level or even to apply for joint assessments at regional level and medicines needed under special circumstances, such as public health emergencies of continental, regional or national scope.
- 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 being to progressively build capacity of regulatory experts on the continent. Product recommendations from the EMP-TC is envisaged to lead to a fast national registration by the 55 National Regulatory Authorities based on the assessment report produced by the EMP-TC using a reliance model.
- The purpose of this notice is to therefore inform the public that the Joint Secretariat of the AMRH is inviting comments on this draft document which will help to finalize it. Please compile your comments specifying the draft section you are commenting on as per an example given below.
This document is open for comments until 30 June 2023. Comments should be emailed to amrh@nepad.org and cc alexj@nepad.org
- The draft Guidance Document can be accessed by clicking here
Issued by:
AMRH EMP TC