Lerato T. Makhurane, Zimbabwe
Organisation: Medicines Control Authority of Zimbabwe
Regulatory Science Fellow (2020 Cohort)
I am a Regulatory Officer at the Medicines Control Authority of Zimbabwe in the Evaluations and Registration Division. Currently a holder of a BSc (Hons) Applied Chemistry, a Diploma in Environmental Health and Safety Management and studying towards a Master in Biotechnology Innovation and Regulatory Science, I have been assessing applications for the registration of medicines since August 2015 and evaluation of post – registration amendments since January 2019 amongst other duties. In addition, I also take part in the evaluation of dossiers at regional level through the Zazibona Collaborative Registration Procedure. Besides actively participating in assessment of medicine applications nationally and regionally, I am also part of the organization’s Public Relations Committee mainly responsible for increasing public health awareness with respect to medicines use and abuse through conducting MCAZ publication relations activities such as outreach campaigns.
An overview of applications for registration of medicines submissions in Zimbabwe – a case of the Medicines Control of Authority of Zimbabwe
The MCAZ registers applications submitted for the registration of medicines through various pathways such as the normal route, expedited, Zazibona and the WHO – PQ CRP. However there has not been priority of medicines application in reviews at MCAZ in terms of therapeutic area and need as an indicator of access. Affordable access to quality medicines and medical devices is critical for functioning health systems and fundamental for obtaining universal health coverage. Availability of generic medicines is important in improving access to medicines. As such, evidence suggests that availability of 3-4 generics of the same product creates sufficient health and comparative market that lowers prices to improve not only availability but affordability. The WHO considers equitable access to safe and affordable medicines as vital to the attainment of the highest possible standard of health by all.
Although the authority prioritizes review of key medicines where there is need, there is no documented policy sufficiently driven by actual evidence. Therefore the aim of this research is to evaluate the multiplicity of generic versions registered by MCAZ based on the national treatment guidelines.
What do you hope to gain from the fellowship?
Firstly, I am looking forward to gaining skills as a researcher leading to the publication of academic research papers suitable for publication in my area of interest. Furthermore, through the methodical – based training offered in the duration of the fellowship, I hope to gain technical skills which will assist me professionally as a national and regional regulator in bettering the health of a society through ensuring that quality, safe and efficacious medicines are available in our market.
Secondly, through the fellowship, I anticipate growth in regional and international exposure in regulatory science. This will also assist me in achieving the fully - effective competency zone (from an effective zone) as an assessor.
Over and above I am looking forward to developing relationships beneficial in my career as a regulator at our national medicines regulatory authority.