During the DIA Global Annual Meeting 2023, Nancy Yang-Ngum developed and presented a poster in which she shared the results, recommendations and conclusions about the topic “Evaluation of the Effectiveness and Efficiency of Ten Years’ Experience with the East Africa Community Joint Assessment”
- The African Medicines Regulatory Harmonisation (AMRH) Initiative came into force in 2009.
- This initiative was established by African Union Development Agency (AUDA-NEPAD) and Partners.
- Aim of AMRH to improve access to medical products and technologies in Africa through harmonisation of medicines regulatory in five regions in Africa (SADC, EAC, IGAD, ECCAS and ECOWAS)
- To operationalise this initiative, Medicines Regulatory Harmonisation Projects were established in all these regions. These projects are operating at different levels of maturity.
- EAC-MRH launched in 2012.
To evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative including the challenges it faces as well as identifying opportunities for improvement from regulators’ and applicants’ perspective.
- Obtain the views of the individual medicines’ regulatory authorities of the EAC-MRH initiative and applicants about the performance of the programme to date.
- Identify the challenges experienced by individual authorities and industries throughout the life cycle of the EAC-MRH initiative.
- Determine the strengths and weaknesses of the initiative.
- Identify the ways of improving the performance of the work sharing programme.
- Envisage the strategy for moving forward.
Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was answered by the EAC Joint Assessment Procedure participants: South Sudan, Uganda, Kenya, Rwanda, Burundi, Zanzibar and Tanzania. The PEER questionnaire is a study tool formed of five sections such as demographics, benefits, challenges, improving the performance of the work-sharing programme and envisaging the strategy for moving forward.
- A harmonised and robust system for tracking applications should be developed.
- Make publicly available information applicants will use to manage their submissions.
- Need for engagement with Industry and clear registration procedure for the EAC Process.
- Initiate training and build capacity.
- Strengthening the EAC-MRH coordination mechanism.
- Stronger mutual recognition is needed between member states.
- Establishment of an EAC regional medicines agency.