Esther Mokaya completed her undergraduate (Bachelor of Pharmacy) in 2008 and postgraduate studies (Master of Pharmacy in Pharmaceutical Analysis) in 2020, both from the University of Nairobi. She is currently in working pharmaceutical industry, with sound background in regulatory affairs, pharmacovigilance, quality assurance and good distribution of pharmaceutical products.
Project Summary
A Retrospective Review of Pharmaceutical Product Dossiers Submitted at the Pharmacy and Poisons Board Between 2010 and 2014
Background:
Efficient regulation of pharmaceutical products ensures that medicines marketed within a specified territory meet the standards of quality, safety and efficacy. The national medicine regulatory authority is responsible for drug regulation by ensuring that the products marketed meet required standards before issuing a registration certificate. The objective of this study was to carry out a retrospective review of dossiers submitted to PPB between January 2010 and December 2014.
Methodology:
The study was carried out at PPB. Data was gathered using a data collection tool, entered into a database then exported to STATA version 14.0 software for analysis. 347 dossiers were reviewed after being stratified based on their respective therapeutic categories. The time taken to obtain registration was calculated. A comparative study was done on the regulatory requirements for dossier submissions in Kenya, Uganda and Tanzania based on the respective drug registration guidelines.
Results and discussion
78.7% of the products had obtained registration within the specified period. Majority of the products were registered in a period of more than 12 months (47%), and 31% were registered in less than 12 months. The median time for registration was 413 days, approximately 14months. Majority of the products submitted were anti-infectives, 31% of the total files reviewed. Kenya’s regulatory processes and requirements were found comparable to those of Uganda and Tanzania.
Conclusion:
The average time taken to register a pharmaceutical product in Kenya was found to be approximately 14 months. The drug registration requirements and practices followed by PPB are comparable to those of Uganda, Tanzania and EAC-Compedium.
Research Supervisors
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Dr. Kennedy O. Abuga, PhD
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Dr. Beatrice K. Amugune, PhD
