Africa: Building Africa's Pharmaceutical Future Starts With Regulation
[New Times] Last week, during a discussion with African vaccine manufacturers, one manufacturer asked me a deceptively simple question:
Last week, an African vaccine manufacturer asked me a question that highlights the importance of the African Medicines Agency (AMA). They inquired whether the agency could streamline the process for manufacturers to reach multiple African markets without having to navigate separate processes in every country. This question touches upon the core purpose of the AMA.
For manufacturers, fragmentation leads to increased costs in terms of time, expertise, and resources. However, the most significant cost is borne by patients when quality-assured innovations take longer than necessary to reach them. To build a sustainable pharmaceutical manufacturing industry in Africa, it is crucial to avoid permanently fragmented pathways to its markets.
The AMA's role is to connect and strengthen existing national regulatory authorities (NRAs), building on harmonisation efforts through Regional Economic Communities (RECs) and other continental initiatives. The goal is to reduce unnecessary duplication, increase predictability, and enable faster access to quality-assured medical products.
However, engaging manufacturers earlier in the process is also essential. AMA's Regulatory Innovation and Manufacturing Readiness Hub aims to create an early entry point where innovators and manufacturers can engage with the agency and NRAs during product development, clinical trials, technology transfer, and manufacturing readiness.
The advice provided is non-binding and serves to help developers understand expectations, generate necessary evidence, and make informed investment and development decisions. This early-engagement approach aligns with the AMA's model and complements the African Continental Free Trade Area (AfCFTA), creating confidence for African countries to procure quality-assured products together.
Achieving this ambition requires not only making standards easier but also making the pathway clearer, more predictable, and more efficient while maintaining rigorous standards of quality, safety, and efficacy. Success will be measured by the strength of national institutions, the empowerment of African innovation and manufacturing, and the timely availability of quality-assured medical products to African patients.
Making pharmaceutical manufacturing "Made in Africa" must ultimately mean being "trusted across Africa and beyond."
Written by urgent.news from AllAfrica Health's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
