Nigeria, with its large patient pool, well trained medical professionals and many research institutions, is an attractive location to conduct clinical trials.
The Nigerian government is supportive of clinical trials and provides financial assistance to various research sites including the National Institute for Medical Research (NIMR). In August 2021, the government announced an increase in investments into research and healthcare development as efforts to boost the health sector.
The National Agency for Food and Drug Administration and Control (NAFDAC) is the regulatory body that oversees clinical trials in the country. It is responsible for protocol review and authorisation of a clinical study before it is conducted in Nigeria. The Agency is also responsible for carrying out inspection of sites to ensure the safety and well-being of trial participants are protected.
The regulations governing clinical trials in Nigeria are in alignment with internationally recognised guidelines. Example, the Good Clinical Practice Guidelines 2020, is adapted from the International Conference Harmonisation-Good Clinical Practice (ICH GCP). Furthermore, the NAFDAC’s Clinical Trial Regulations, 2021, sets out the standards required to conduct clinical trials are broadly similar to those in Sub-Saharan Africa, including South Africa and Tanzania.
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