scholarly journals Joint Medicines Regulatory Procedure in the East African Community: Registration Timelines and Way Forward

2021 ◽  
Author(s):  
Jane Mashingia ◽  
S Maboko ◽  
P I Mbwiri ◽  
A Okello ◽  
S I Ahmada ◽  
...  
Keyword(s):  
Marketing Authorisation ◽  
Regulatory System ◽  
System Optimization ◽  
Minimum Time ◽  
East African ◽  
Scientific Review ◽  
Regulatory Review ◽  
East African Community ◽  
Maximum Time ◽  
African Community

A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time was 44 days. For applicants, the maximum time to respond to queries was 927 days and the minimum time was nine days. The total median time for granting marketing authorisation by the National Medicines Regulatory Authorities (NMRA) decreased from 174 to 39 working days in 2015 and 2019 respectively. However, not all EAC NMRA has granted marketing authorisation to all 57 products due to non-payment of applicable fees by applicants. Long regulatory approval timelines were contributed by limited capacity for timely scientific review of dossier by some NMRA, lack of online portal to share dossiersand assessment reports, delay in responding to queries by applicants and deficiencies in dossier. The metric tool and register of medical products submitted for joint scientific review had incomplete data. Challenges were identified and actions recommended to ensure regional regulatory system optimization, efficiency, transparency, sustainability and accountability.

scholarly journals Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania

2021 ◽  
Vol 18 (4) ◽  
pp. 1941
Author(s):  
Abbie Barry ◽  
Sten Olsson ◽  
Christabel Khaemba ◽  
Joseph Kabatende ◽  
Tigist Dires ◽  
...  
Keyword(s):  
Neglected Tropical Diseases ◽  
Individual Case ◽  
Health Programs ◽  
Pharmacovigilance System ◽  
Tropical Diseases ◽  
East African ◽  
East African Community ◽  
Public Health Programs ◽  
Assessment And Evaluation ◽  
African Community

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

The East African Community

2021 ◽  
Author(s):  
Jean-Marc Trouille ◽  
Helen Trouille ◽  
Penine Uwimbabazi
Keyword(s):  
East African ◽  
East African Community ◽  
African Community
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