Medicines Regulatory Authority Support

Medicines regulatory authorities are responsible for ensuring that all medicines products available on the market under their jurisdiction are safe, effective and of assured quality. This is done by assessing and licensing products and manufacturing facilities, inspection of distribution channels, laboratory testing of product quality, monitoring of adverse reactions (side effects), and control of advertising and clinical trials.

Performing all these functions requires highly trained technical staff and sufficient funds, which often are not available in low and middle income countries. This leads to unsafe, ineffective or substandard medicines products being available on the markets, unjustifiable long registration times and/or unavailability of certain medicines.

HERA partners have trained and assisted staff of African Drug Regulatory Authorities. Regulators of Tanzania, Uganda and Zimbabwe have worked with HERA to assist their colleagues in Kenya and Burundi.

HERA has supported regional medicines regulatory harmonisation initiatives in the CARICOM, SADC, and EAC regions through Medicines Regulatory Authorities assessments, participatory development of harmonisation strategies, and ongoing technical and networking support.

In Burundi, HERA has assisted the MOH developing a phased approach for implementing medicines regulatory activities, taking into account the specific resource constraints of the country. This included the establishment of a network of peers in the EAC region.

In Suriname, HERA supported the MOH in revising the medicines legislation and organisational set-up of the regulatory authority.