If you were a manufacturer of medical supplies with market openings in multiple East African Community (EAC) Partner States, you would have to wait at least two weeks, to register the products in each of the countries. Furthermore, you would discover similarities in some of the registration documents, thus having to enter the same information multiple times. Meanwhile, the prolonged processes would delay stocking of your medical products like medicine, by EAC traders, and consumers would suffer.
Medical products imported into any EAC country must adhere to regulations of the country’s National Medicines Regulatory Authority (NMRA), which vary across the countries. For manufacturers registering their products in multiple partner states, the process is time consuming and expensive, as accessing compliance information for each partner state is tedious. This often results in delayed access to essential medicines, and in some cases, reduced compliance to regulations that ensure safety of medicines and medical devices, which may put millions of lives at risk.
To overcome these challenges, the EAC Secretariat is working with EAC Partner States to harmonise regulation of medicines across the region. One of the interventions of the EAC Medicines Regulatory Harmonisation (EAC-MRH) Programme is to establish an Information Management System named, EAC Food and Drug Authority Regional Information Sharing Platform, that facilitates exchanging critical information on the requirements for pharmaceutical registration, and the required standards for medicines, processed foods, and medical devices. The system will enable different NMRAs to jointly register manufacturers through a single application; and other stakeholders to access information and statistics consolidated from the different authorities. The US$1,100,000 is funded by USAID and UKaid with a target completion date of 2022.
During implementation of Strategy one (2010 to 2017), TMA supported NMRAs to automate their trade related processes by digitising import and export regulatory and trade procedures of pharmaceutical products to reduce pre-clearance and clearance cost and time and harness the gains. In strategy two, TMA is working with the NMRAs to integrate their national systems to the EAC Food and Drug Authority Regional Information Sharing Platform (FDA-ISP) to facilitate exchange of information. The support includes software development, installation of necessary information technology infrastructure, and change management. The FDA-ISP will enable centralised management of processes related to:
- Online application and processing of joint product registration, such as joint assessments and approvals of applications by NMRAs.
- Online application and processing of joint Good Manufacturing Practice (GMP) inspection. Established jointly by the NMRAs, the GMP guidelines outline the standards manufacturers’ products must meet to be registered. Manufacturers will be able to apply for joint inspection of their production facilities by the NMRAs.
- Online public and internal reports for various information databases and statistical datasets. These include lists of medicine and medical devices licensed across the region, their classification, and GMP listing. Summary statistics of partner states will also be published.
Targeted Results
- Improved access to pharmaceutical regulatory services – product and premise registration, and GMP inspection.
- Increased collaboration by, and mutual recognition of approvals made by the NMRAs in the registration process.
- Increased compliance by manufacturers and other actors who trade in pharmaceutical products.
- Reduced time and cost of application and processing of product registration and GMP inspection by eliminating duplicated effort – providing for a single application by a manufacturer and joint NMRA assessments and approvals.
Implementing Partners: EAC, National Drug Authority of Uganda, Pharmacy and Poisons Board of Kenya, Rwanda Food and Drugs Authority, Tanzania Medicines and Medical Devices Authority, Zanzibar Food and Drugs Board, Burundi’s Department of Pharmacy, Medicines and Laboratories, and South Sudan’s Drug and Food Control Authority.
