Herbal Medicine For COVID-19: FDA Approves Herbal Medicine For Clinical Trial
Herbal Medicine For COVID-19
The Food and Drugs Authority (FDA), the National Medicine Regulatory Agency (NMRA) in Ghana, has approved a herbal medicine, ‘Cryptolepis sanguinolenta‘, locally known as Nibima for clinical trials in January 2021.
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 pandemic.
The submission follows results from laboratory studies conducted by the KNUST research team which points in the direction of possible clinical benefit.
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 indicates Ghana’s medicine 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 and exported, manufactured or distributed in the country including the regulation of the conduct of clinical trials.
The Authority has therefore given 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 herbal medicine for Covid-19 trial of the locally known medicine will be conducted at two sites.
The team of researchers for the past years involved in FDA’s stakeholder engagements and capacity building activities and has an in-depth experience as well as the knowledge in the international and national regulatory requirements requisite for the effective conduct of clinical trials.
The sites have adequate capacity to ensure the safety of participants as well as produce credible scientific data.
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