Why You Should be Conducting Clinical Trials in South Africa?
- Large numbers of healthy and sick reliable patients to participate in various phases of clinical trials
- Genetically diverse populations
- Easy access to patients
- High-quality and well-trained medical professionals, often internationally trained
- Modern health care facilities and private clinics supplying the latest technology combined with highly experienced and trained staff
- Potential for cost savings
Regulatory Applications in South Africa
The review and approval process currently averages between 12 to 16 weeks from the time an application is submitted to the Ministry’s Medicines Control Council (MCC) – the regulatory agency that oversees clinical trials in South Africa – until an approval is rendered.
Clinical Trial Insurance must be obtained from a company located in South Africa. If global insurance the company providing the cover must have representation (offices) in South Africa.
Depending on trial indication the MCC may enforce post trial drug access. This is reviewed on a case by case basis.
Export permits per investigator site are required for shipping biological samples to central laboratories outside South Africa. A separate application is submitted to the Department of Health after Ethics Approval has been obtained. This usually takes 4-8 weeks from date of submission.
All trials must be registered in the national registry and a trial number called DOH issued prior to trial commencement.
Data from studies conducted in South Africa have been widely accepted by both the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMA).
The country’s Ministry of Health requires adherence to ICH GCP guidelines for the conduct of clinical trials, and the MCC enforces national GCP regulations.
All clinical trials for nonregistered biopharmaceutical products or new indications for registered products must be reviewed and approved by the MCC.
A comprehensive application form must be accompanied by the investigator’s brochure, study protocol, Informed Consent Form, together with other documents such as proof of GCP training for the investigators and personnel involved in the study, Investigators and site personnel CV, time allocation, MCC declaration form and insurance.
In addition to MCC approval, all clinical trials must be approved by an accredited Ethical Committee (EC ). The application must be sumitted to a local central EC for review and approval. The review process is faster (4 to 8 weeks) and a conditional approval may be granted until MCC approves the study. In some instances, additional applications to institutional EC s (universities, hospital or clinic) may be required.
An approval letter from the MCC allows the study to commence and also permits the importation of the investigational product.
To date, over 2389 trials are registered on clinicaltrials.gov including 302 active studies. These studies are conducted across a wide spectrum of therapeutic areas.
Quick facts about South Africa
Situated at the southern tip of Africa, South Africa is 1 233 404km² in size and is edged on three sides by nearly 3000 km of coastline, with the Indian Ocean to the east and the Atlantic Ocean to the west. The country is bordered in the north by Namibia, Botswana, Zimbabwe and Mozambique, and also encloses two independent countries, the kingdoms of Lesotho and Swaziland.
South Africa is a nation of about 55 million (2016) people of diverse origins, cultures, languages, and religions. Statistics South Africa asks people to describe themselves in the census in terms of five racial population groups. The 2011 census figures for these groups were Black African at 79.2%, White at 8.9%, Colored at 8.9% (a term used in South Africa to describe people of mixed race), Asian at 2.5%, and Other/Unspecified at 0.5%. Just over half the population is female.
South Africa is a multilingual country and there are 11 official languages, namely: English, Afrikaans, isiNdebele, isiXhosa, isiZulu, Sepedi, Sesotho, Setswana, Siswati, Tshivenda and Xitsonga. Although only about 10% of the population has English as its mother tongue, English is the language most widely understood, and is the second language of the majority of South Africans.
South Africa has been well known for its medical skill since Professor Christiaan Barnard performed the first successful human heart transplant in the country in 1967. The standard of healthcare in South Africa is considered the best on the continent of Africa.
There are 4 200 public health facilities in South Africa and over 500 private hospitals. There are many world-class private hospitals and medical centers around the country, especially in the urban areas, while many state hospitals also offer excellent care, among them Groote Schuur Hospital in Cape Town. The hospital facilities in major cities such as Johannesburg are clearly impressive attracting patients from all over the world.
The National Health Laboratory Service is the largest pathology service in South Africa. It has 265 laboratories, serving 80% of South Africans. The laboratories provide diagnostic services as well as health-related research.
South Africa has a mixed economy, the second largest in Africa after Nigeria. In August 2013, South Africa was ranked as the top African Country of the Future by FDi magazine based on the country’s economic potential, labor environment, cost-effectiveness, infrastructure, business friendliness, and foreign direct investment Strategy.
We are responsible, responsive, committed and flexible
ARIANNE has a strong international regulatory understanding, and a corporate commitment to partnership development and long-term relationships with a strong team approach.
ARIANNE is fully compliant with ICH, GCP and regional guidelines and provides a global reach as well as cost-effective solutions.
ARIANNE in South Africa
ARIANNE has built strong relationships with experienced investigators and qualified academic and private medical sites. We maintain strong relationships with local hospitals and medical centers.
Locally, we are closely involved in training and managing all site personnel involved in our studies.
Worldwide, all of our offices follow the established quality assurance systems, standard operating procedures to maintain quality and ensure compliance with all regulations and study requirements as our North American Offices as well as adhering to international guidelines.
Our foreign staff is fluent in the native languages and English and maintains the appropriate infrastructure to support the studies we conduct, including concise communications and information technology systems.