FDA laboratory acquires first WHO prequalification in ECOWAS

The Drugs Laboratory

The Drugs Laboratory at the Centre for Laboratory Services and Research (CLSR) of the Ghana Food and Drugs Authority (FDA) has been awarded a WHO-Prequalified Quality Control Laboratory (QCL) Status.

By this achievement, the FDA is now the first and only food and drugs regulatory agency within the ECOWAS sub-region to be recognised internationally as a competent institution that can test medicines and medical products under WHO auspices.

The results from medicines tested by the FDA will therefore henceforth become acceptable to all countries.

The benefits of this new FDA status include the following:  (i) The Laboratory will serve as a Regional Centre of Excellence and  train other National Drug Regulatory Agencies in the sub-region; (ii) the FDA can fully participate in international tenders to analyse products that are to be procured by UN agencies, such as UNICEF and the Global Fund; and  (iii) the Certificate of Analysis for locally manufactured medicines in Ghana will receive international recognition, and thereby boost their permeation into the international market. With the prequalified lab in Ghana, the African Continental Free Trade Area provides additional opportunity to Ghanaian pharmaceutical companies within the Africa market.

The FDA Laboratory has by this feat become a key international player in the testing and verifying of Finished Pharmaceutical Products to ensure they meet international standards of safety, quality and efficacy, and will therefore require all the necessary support to maintain this new status.

Additionally, it is to be noted that once the FDA Laboratory has become a prequalified QCL, the FDA may be invited to participate in WHO prequalification monitoring projects that are undertaken periodically to assess the quality of medicines procured by UN agencies.

With this accomplishment by the FDA Laboratory as the only WHO-prequalified laboratory in the ECOWAS sub-region, the Authority is in readiness and poised to provide effective regulation to support the national vaccine manufacturing agenda, and ensure access to quality, safe and efficacious vaccines and medicines for the nation and the African continent.

CEO of the FDA, Mrs. Delese Mimi Darko, commenting on the feat said: “This pre-qualification is a great achievement for the FDA and the sub-region as a whole. We have been working diligently on it for more than three years. This is a great achievement for Ghana and the sub-region”.

Leave a Reply