The Food and Drugs Authority (FDA), has approved a herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima, for clinical trials in January 2021.
The trial is being executed by researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology (KNUST).
The researchers, according to a statement released by the FDA, a National Medicine Regulatory Agency (NMRA), on Monday, February 1, 2021, submitted a clinical trial application in September 2020 to assess the safety and efficacy of Cryptolepis sanguinolenta as a potential treatment for COVID-19.
This was in search for a treatment for the ongoing COVID-19 pandemic.
This follows results from laboratory studies conducted by the KNUST research team which points in the direction of possible clinical benefits.
The FDA Ghana is listed as a World Health Organization (WHO) “Maturity Level 3” Regulatory Agency, the second country in the WHO African Region to attain this level in the four-tier WHO classification of National Medicines Regulatory Systems.
This level, the second within this classification, indicates that Ghana’s medicines regulatory system is well functioning and integrates all required elements to guarantee its stable performance, thereby, ensuring the safety, quality and efficacy of all medical products imported, exported, manufactured, or distributed in the country including the regulation of the conduct of clinical trials.
According to the FDA, after detailed assessment of the application, gave the requisite regulatory authorization for the conduct of the trial as per the mandate outlined under Part 8 (Section 150 -166) of the Public Health Act 2012 (Act 851), which gives the Authority the legal mandate to regulate clinical trials of drugs, herbal medicinal products, cosmetics or medical devices.
The trial, the FDA added, will be conducted in two sites that have adequate capacity to ensure the safety of participants as well as produce credible scientific data.
“It is hoped that the data from this study may be useful to inform policy or be used for scientific judgments and opinions in relation to COVID-19”, the statement released by the FDA in part read.
