Experts from the East African Community Partner States’ National Medicines Regulatory Authorities have converged in Entebbe, Uganda, to scientifically review the safety, efficacy, and quality of 20 medical products.
The assessment is expected to take five days of restructuring medicines and registration procedures to ensure quality, safe and efficient medicines are delivered in the region from February 7-11, 2022.
The experts will also harmonise technical documents to ensure uniform medicine evaluation and shun duplication of efforts between medicine regulatory authorities in the EAC region.
The experts will use their experiences and medical knowledge concerning medicine registration requirements of their countries, the World Health Organization (WHO), and the International Conference on Harmonization of Technical Requirements for Registration of Medicines for Human Use (ICH) to mention but a few.
Kenya’s Head of Regional Coordination, Pharmacy and Poisons Boards, Dr Felistas Chepwogen, noted that medicine regulation was lacking in the region, rendering the region’s substandard medicines.
Dr Felistas cited factors like scarce human and infrastructural capacity in regulations, varying standards of regulations, and the long chain of procedures in introducing new medicines to the market.
“As a region, we are now able to facilitate timely assessments and approvals of medicinal product dossiers by the regulatory authorities for pre-marketing evaluation, marketing authorisation/registration and post-marketing review through such regional joint assessment sessions,” Dr Felistas noted.
The Director of Product Assessment and Registration, Dr Juliet Okecho, National Drug Authority, Republic of Uganda, commended the efforts of the EAC Secretariat in coordinating the National Medicines Regulatory Authorities through the notable step of limiting substandard and counterfeit medicines through partnership in the East African region.
“I commend the collaborative efforts by EAC aimed at harnessing resources and supporting harmonisation efforts on Medicine Evaluation and Registration (MER) within the region given the limited capacities of individual member states,” Dr Okecho said.
Jane Mashingia, the EAC Regional Technical Advisor at the East African Community Medicine Regulatory Harmonisation (EAC-MRH) Programme on behalf of the EAC Secretary-General, said the pharmaceutical manufacturers have submitted 169 applications for joint scientific review of their manufactured medicines.
“Out of the 169 applications, 79 medical products have been recommended for marketing authorisation, 20 new applications are currently under review, while the remaining are at different stages of review including more than 50 applications awaiting applicant responses to queries raised by regulators,” said Mashingia.
“Every country is obligated to regulate the pharmaceutical products sold within its borders. This includes, among others, pre-approval scientific assessment of essential medicines (registration) so that citizens can access these medicines and be assured that they meet acceptable standards of safety, quality, and efficacy.”
Policy
The harmonisation of medicines registration is a policy under Chapter 21, Article 118 of the East African Community Treaty. It ensures the free movement of goods concerning the EAC Common Market Protocol.
The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme is intertwined with the African Medicine Regulatory Harmonisation (AMRH).
EAC-MRH programme aims to address the lack of standard approaches in the regulation of medicine, vaccines and medical devices.
Regional bloc
Through strong cooperation, the EAC aims to increase mutual benefits among the partner states, both politically, economically and socially.
Among the most significant treaties include the East African Customs Union, the establishment of the Common Market in 2010 and the implementation of the East African Monetary Union Protocol.
The strength lies in the readiness of East African leaders and citizens to achieve a powerful and sustainable economic and political bloc in East Africa.