Harmonisation moving toward regulatory alignment

AFRICA stands out as a highly attractive frontier for pharmaceutical growth, fueled by rapid population expansion, a rising disease burden, and increasing demand for high-quality healthcare solutions.

- DR VIKAS PANDEY

However, despite these opportunities, drug registration and approval processes across African countries are complex and heterogeneous. For pharmaceutical companies seeking to enter or scale operations in this evolving market, a clear understanding of the regulatory landscape is essential.

Unlike US FDA or the European Medicines Agency (EMA), Africa lacks a single centralised regulatory authority, with each country overseeing drug approvals through its own National Medicines Regulatory Authority (NMRA), characterised by distinct requirements, documentation formats, and timelines. Although the continent comprises numerous countries with diverse pharmaceutical regulatory systems, recent initiatives such as the African Medicines Agency (AMA) and regional harmonisation efforts are gradually moving toward greater regulatory alignment.

Most African countries accept the CTD dossier format for drug registration; however, each nation operates through its own National Regulatory Authority (NRA), such as NAFDAC in Nigeria or SAHPRA in South Africa. These authorities are responsible for overseeing product registration, importation licensing, compliance with Good Manufacturing Practices (GMP), and pricing and reimbursement regulations.

Regional Regulatory Frameworks

Africa's regulatory environment is gradually evolving from fragmented national systems toward greater harmonisation, driven mainly by the African Medicines Agency (AMA) and Regional Economic Communities (RECs) such as the EAC and ECOWAS. Through initiatives like the African Medicines Regulatory Harmonisation (AMRH) programme, these efforts emphasise common standards for quality medicines and seek to enable unified approval pathways, joint assessments, and mutual recognition. Nevertheless, significant challenges persist in achieving full implementation across diverse sectors, including digital finance and energy.