S105: Evaluation of Good Review Practices in member agencies of the East African Medicines Regulatory Harmonisation Initiative
Poster Presenter
Nancy Biyeah Yang Ngum
Student
University of Hertfordshire United Kingdom
Objectives
To evaluate Good Review Practices (GReVP) in the agencies participating in the East African Medicine Regulatory Harmonisation Initiative and map strategies for moving forward as they are going through the process of alignment for the operationalisation of the African Medicines Agency (AMA).
Method
An established standardised questionnaire, the OpERA, which captures review processes was completed by the Head of the medicine’s registration division in each of the seven NRAs. A country report based on the completed questionnaire for each NRA was validated by the heads of the respective agencies
Results
The East African Community Medicines Regulatory Harmonization (EAC-MRH) regional initiative consists of seven agencies, namely Burundi, Kenya, Uganda, Rwanda, South Sudan, Tanzania and Zanzibar. A comparison of the quality measures recorded by the regulatory authorities indicated that Kenya, Rwanda and Tanzania implemented all eight quality measures while Uganda implemented 6, Zanzibar 4 and Burundi 5 out of eight. Apart from Zanzibar all five agencies used scientific expert committees. Only Uganda indicated that they did not have standard operating procedures and Burundi did not have assessment templates in place. All NRAs except Burundi are implementing a quality policy while except for Uganda and Zanzibar all four NRAs have a dedicated quality department. All six NRAs participated in shared and joint reviews. However, South Sudan did not implement any of the measures possibly because they are currently not reviewing any products.
On assessing the implementation of nine best practices on transparency and communication all six agencies reported that they have in place official guidelines to assist industry and a list of approved products that allow for industry to track the progress of their applications via email and telephone. Three agencies did not provide post-approval feedback to applicants on the quality of the submitted dossiers. Three agencies namely Kenya, Uganda and Tanzania reported that they do publish summary of assessment reports on which the approval was granted.
External and internal quality audits; internal tracking systems, reviews of assessors’ and stakeholders’ feedback, were assessed to determine continuous improvement initiatives. Tanzania and Zanzibar implemented all five initiatives, while Uganda and Kenya implemented four of the five initiatives. Rwanda implemented three and Burundi two out of five. All six countries implemented measures on training and education and quality decision making practices
Conclusion
Good Review Practices of agencies in the East African Medicine Regulatory Harmonisation Initiative could still be improved. This study has demonstrated how the EAC-MRH performs regulatory reviews in order to improve the capacity of NRAs.
For the AMA to be successful, country regulatory processes need to be streamlined and differences in country requirements minimised. Like the EAC-MRH, the AMA will also depend on countries to implement the decisions recommended by this continental body. It is therefore crucial that the operationalisation of the AMA focuses on improving the review practices of the NRAs to minimise any delay in granting marketing authorisation to medical products. It is imperative for countries to implement good review practices to accelerate patients’ access to safe, quality and effective medical products when the AMA is fully operationalised.
Recommendations
Measuring & Monitoring Timelines. Agencies in the EAC-MRH initiative should implement systems that will enhance the measurement and monitoring of timelines for the key milestones of the registration process such as dates of submission, validation, start of scientific assessment, completion of scientific assessment and registration.
Applicants Communication: Clear registration processes should be documented and shared with the applicants as well as publishing timelines, assessment reports, and the summary basis of approval which will facilitate transparency and accountability.
Work-Sharing: The EAC-MRH should develop measures to mandate the registration of products at a national level following regional recommendation. This approach would ultimately lead to faster availability of medicines to patients as well as reducing demand on capacity.
Quality Decision-Making Practices: While the agencies indicated they are implementing quality decision making practices, there is still a need for further training and education to optimise decision making, meeting target timelines and patients’ needs
