The Food and Drugs Authority (FDA) and the National Medicine Regulatory Agency (NMRA) in Ghana, have approved a herbal medicine, Cryptolepis Sanguinoleta, locally known as Nibima for clinical trials in January 2021.
According to the FDA, in search of a treatment for the ongoing covid-19 pandemic, researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology (KNUST), submitted a clinical trial application in September 2020 to assess the safety and efficacy of Cryptolepis Sanguinolenta as a potential treatment for covid-19.
In a statement sighted by ThinkNews Online, it said “The FDA Ghana is listed as a World Health Organisation (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 disturbed in the country including of the conduct of clinical trials”
The statement also added that after a detailed assessment of the application gave the requisite regulatory authority for the conduct of the trial as per the mandate outlined under part 8 (Sections 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.
FDA says the trial will be conducted at two sites.
Below is a copy of the release:
Story by: Joshua Kwabena Smith