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Table 3 How can the medicine registration processes in Africa be improved?

From: Combating poor-quality anti-malarial medicines: a call to action

Today’s current environment

A harmonized future environment

~50 different NMRAs (working
 independently) to register medicines across Africa


~5 or 6 regional groups (each with
 harmonized technical requirements) coordinating registration across the entire
 African continent

Different administrative and technical
 requirements, processes, and procedures for
 medicines registration across NMRAs

Common (harmonized) registration documentation (format and technical
 requirements),
 procedures, and decision-making processes across African regional groups

No clear indication of the time taken, or the
 maximum
 times allowed, for regulators to
 assess and register medicines

Streamlined processes that are faster, more
 predictable, and better aligned to public health needs (in terms of prioritization, conditional approvals, etc.)

Limited transparency before or during the registration process

Transparent and clear procedures and a good understanding of registration
 requirements and processes by all stakeholders

  1. Source: The New Partnership for Africa’s Development (NEPAD) and the World Health Organization (WHO). African Medicines Registration Harmonisation Initiative: Summary, Status and Future Plans [71]