TY - JOUR
T1 - Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities
AU - Owusu-Asante, Mercy
AU - Darko, Delese Mimi
AU - Asamoah-Okyere, Kwame Dei
AU - Asante-Boateng, Samuel
AU - Kermad, Adem
AU - Walker, Stuart
AU - Salek, Sam
N1 - © The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License,. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
PY - 2023/3/31
Y1 - 2023/3/31
N2 - Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making practices and evaluating the overall regulatory performance from 2019 to 2021, as well as the challenges and opportunities for improvement. Methods: The FDA Ghana representatives completed the optimising efficiencies in regulatory agencies (OpERA) questionnaire, including data identifying the milestones and overall approval times for all products registered by the FDA Ghana from 2019 to 2021. Results: Of the new active substances approved from 2019 to 2021, 91% were biologicals processed by full or abridged reviews pathways. Timelines for these reviews were within authority targets but were longer compared with generics. Of generics approved from 2019 to 2021, 97% were pharmaceuticals processed by the full review pathway, with timelines within authority targets and shorter compared with new active substances. Regardless of the review model used, approval times for new active substances increased from 84 to 355 calendar days 2019–2021 due to the impact of the pandemic. Guidelines, standard operating procedures and review templates were in place and the majority of indicators for good review practices were implemented. Several quality decision-making practices were implemented, although currently there is not a systematic structured approach. Conclusion: The FDA Ghana monitors regulatory performance and currently meets its target timelines. To achieve World Health Organization Maturity Level 4 status, an electronic tracking system, benefit-risk assessment framework and template and the publication of assessment reports are recommended.
AB - Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making practices and evaluating the overall regulatory performance from 2019 to 2021, as well as the challenges and opportunities for improvement. Methods: The FDA Ghana representatives completed the optimising efficiencies in regulatory agencies (OpERA) questionnaire, including data identifying the milestones and overall approval times for all products registered by the FDA Ghana from 2019 to 2021. Results: Of the new active substances approved from 2019 to 2021, 91% were biologicals processed by full or abridged reviews pathways. Timelines for these reviews were within authority targets but were longer compared with generics. Of generics approved from 2019 to 2021, 97% were pharmaceuticals processed by the full review pathway, with timelines within authority targets and shorter compared with new active substances. Regardless of the review model used, approval times for new active substances increased from 84 to 355 calendar days 2019–2021 due to the impact of the pandemic. Guidelines, standard operating procedures and review templates were in place and the majority of indicators for good review practices were implemented. Several quality decision-making practices were implemented, although currently there is not a systematic structured approach. Conclusion: The FDA Ghana monitors regulatory performance and currently meets its target timelines. To achieve World Health Organization Maturity Level 4 status, an electronic tracking system, benefit-risk assessment framework and template and the publication of assessment reports are recommended.
KW - Original Research
KW - FDA Ghana
KW - Regulatory review models
KW - Good review practices
KW - Regulatory timelines
KW - Quality decision-making practices
KW - WHO GBT
UR - http://www.scopus.com/inward/record.url?scp=85141643927&partnerID=8YFLogxK
U2 - 10.1007/s43441-022-00478-x
DO - 10.1007/s43441-022-00478-x
M3 - Article
SN - 2168-4790
VL - 57
SP - 372
EP - 385
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
IS - 2
ER -