The African Medicines Agency (AMA) and the US Pharmacopeia (USP) have formalised a new partnership to strengthen medicines regulation, quality assurance and pharmaceutical manufacturing systems across Africa.
The memorandum of understanding, signed in Johannesburg on 29 April, establishes a framework for collaboration on regulatory science, pharmacopeial standards, post-market surveillance and technical capacity building.
Under the agreement, the organisations will work to strengthen national regulatory authorities, improve quality monitoring systems and support regulatory harmonisation across African countries.
The agreement also aims to advance systems for biologics and advanced therapies and support local pharmaceutical manufacturing.
The MoU was signed during the 3rd Africa Regional Chapter meeting of the USP Convention, focused on localisation and regulatory capacity building for biologics and advanced therapies in Africa.
A joint technical working group will oversee implementation of the partnership’s work plans.
AMA director-general Dr Delese Mimi Darko said the partnership would help strengthen coordinated regulatory systems and support efforts to combat substandard and falsified medicines across the region.
USP said the agreement builds on its broader work in Africa on medicines quality, regulatory strengthening and manufacturing resilience, including previous collaborations with Africa CDC, South Africa’s SAHPRA regulator and the Nigerian government.