Clinical research according to ICH-GCP is defined as, “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.”
South Africa stands in 10th position in contributing to clinical trials globally. Clinical trials as best method for testing and evaluating new drugs and treatment techniques are well recognized in South Africa. Availability of modern health care facilities, large and diverse patient pool, well qualified scientific personnel and low capital investment per study, in South African research community are a few factors that attract hundreds of trial sponsors to conduct cost-effective, high quality clinical studies in South Africa.
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In ancient South Africa, the National Health laboratory services failed to provide discounts for research tests, and the Medical Research Council has been chronically underfunded despite its important mandate for maintaining the development of country’s clinical research capacity. The reinvigoration of clinical research in South Africa by Academy of Science of South Africa (ASSAf) and the government’s 10 year science and technology plan on development of new medicines and other biologically useful agents opened new doors to drug development process in the country.
Dramatic changes have occurred throughout South Africa in recent years in spite of the misconceptions of clinical research in the past. South Africa today is the richest and most economically developed country in the continent. Most of the South Africans concentrated in urban regions provides a large number of patient pool for clinical studies. The presence of large size treatment naïve subjects is a key factor for the clinical development process in South Africa.
As already mentioned, South Africa is the most economically developed country, conducting clinical trials is more cost effective than in any other western countries. This forms a basis for the frequent conduct of bioavailability and bioequivalence studies in South Africa. The availability of expertise in bioequivalence testing and other related services makes the generic drug manufactures to perform such studies in South Africa at low cost per trial. Also the availability of large number of healthy volunteers to participate in such trials is an added advantage for saving the time and resources for clinical trial conduct.
South Africa has stringent regulations to get approval for conducting a clinical study. The Ministry’s Medicine Control Council (MCC) is the regulatory agency that approves the code and conduct of a clinical trial in South Africa. It also enforces the national Good Clinical Practice regulations in clinical trial conduct. The time required for the regulatory approval is the limiting step to start new clinical trials in South Africa; however the fact is that South Africa has a well-established regulatory process based on ICH GCP guidelines.
In addition, the study has to get approved by accredited ethics committee which takes an average of two weeks for the approval process. As the South African regulations are very stringent, sponsors approach the local CRO’s, SMO’s for the clinical trial regulatory approval process and its conduct in the country.
James Lind Institute (JLI) provides multiple clinical research, medical writing, pharmacovigilance, quality assurance and business development related courses in South Africa to students who wish to make a career in this industry. JLI, an educational division of Clinexa Life Sciences offers online training in clinical research and allied areas to South African candidates with access to highly experienced and trained mentors and faculty from India and abroad. To know more about how programs from JLI can help your career, please visit the main page of our website HERE
