Officials of the various regulatory agencies after the signing ceremony
The Food and Drugs Authority (FDA) has signed a Memorandum OF Understanding (MOU) with eight African National Medicine Authorities to strengthen regulatory systems on the Continent.
The signing ceremony which took place in Cairo, Egypt, aims to improve access to essential medicines, vaccines and medical devices across the continent.
The MOU signed by the FDA of Ghana, the National Agency for Food and Drugs Administration and Control (NAFDAC) of Nigeria, Rwanda Food and Drugs Authority (FDA), the Senegalese Pharmaceutical Regulatory Agency (ARP), South African Health Product Regulatory Authority (SAHPRA), Tanzania Medicine and Medical Devices Authority (TMDA) and Medicines Control Authority of Zimbabwe (MCAZ) is to foster the collaboration and reliance on regulatory decisions among signatory agencies while also propelling an enabling environment for local production of medical products.
A release by the FDA indicated that by the agreement, the signatories commit to streamline application submissions and evaluation processes to expedite regulatory processes, reduce costs and ensure timely regulatory decision making.
“The MOU also establishes mechanism to ensure that authorized products and clinical trials meet internationally accepted regulatory standards.
The MOU will facilitate the sharing of assessment reports, quality control laboratory results and good manufacturing or clinical practice inspection report among the parties which will reduce duplication of work and enhance efficiency.
Also, there will be timely access to medicines due to shared regulatory decisions will help accelerate access to essential medicines, vaccines and medical devices across Africa,” the release indicated.
Again, it said the MOU will foster cooperative environment where regulatory authorities can support one another, benefiting from each other’s scientific expertise while maintaining their independent regulatory responsibilities.
This will also help countries with limited regulatory resources to rely on stronger agencies, allowing them to enhance their regulatory capacity without compromising public health standards.
The MoU represents a monumental achievement for African Regulatory Harmonization (AMRH) initiative and a significant step toward strengthening Africa’s Regulatory systems, it said.
By Florence Asamoah Adom