Clinical Research

Clinical Trials / Clinical Research in Tanzania

In Tanzania, Health Research was started in 1897 by the incident of opening a laboratory by Dr. Koch, a German scientist. In 50 years of the country’s Independence, a lot has been done in health research, as reported by an official Newspaper.

In 1912, epidemiological studies were conducted by seven Germans, following an outbreak of sleeping sickness in the Northwest Tanganyika. A human Trypanosomiasis Research Laboratory was established at Tinde after the First World War. This led to the training of many medical assistants in many medical schools which were started after the laboratory. A Newspaper report states, “Prof. Lyamuya says that soon after independence, three enemies including ill health, ignorance and poverty were identified as key impediments to development in Tanzania.”

After independence, there has been a revolution in medical research and an increase in the number of English speaking medical professionals. This has lead to a significant development of clinical research industry in the country. Off-late Tanzania is becoming a hub for clinical trials especially in the therapeutic areas like HIV, Oncology, Diabetes, Infectious diseases etc.

The Tanzania Food and Drugs Authority (TFDA) is a regulatory body under the Ministry of Health and Social Welfare which is responsible for regulating the quality and safety of food, drugs, cosmetics and medical devices in Tanzania. The TFDA laid very stringent rules and regulations and developed guidelines for the conduct of clinical research in the country. The stringent regulations laid down by TFDA ensure that the data generated is highly reliable and globally acceptable.

The TFDA is about to start online protocol registration through the Tanzania Clinical Trial Registry (TzCTR) system. TFDA has setup a set of guidelines for application to conduct clinical trials in Tanzania which were made under Section 63(1) of the Tanzania Food, Drugs and Cosmetics Act, 2003 and guidelines for reporting of safety data in clinical trials which were made under Section 70(2) of the Tanzania Food, Drugs and Cosmetics Act, 2003.

The TFDA is responsible for ensuring that all the clinical trials obtain a written authorization for the conduct of clinical trials in Tanzania. The authority had also adopted the use of ICH-GCP in addition to the TFDA guidelines when generating the clinical trial data. These guidelines provide guidance on the required current standards for the clinical trial conduct involving drugs, medical devices or herbal drugs in Tanzania.

The Tanzania Food, Drugs and Cosmetics Act 2003, provides for the regulation and control of clinical trials in the country. Section 62 of the Act prohibits any person to conduct a clinical trial on any drug, medical device or herbal drug without the written authorization of the Director General. Section 63 (1) requires any person wishing to conduct a clinical trial of a drug, medical device or herbal drug to submit to the Authority an application in prescribed form signed by him and accompanied with prescribed fee, an Ethical Clearance Certificate issued by any approved institute for medical research and any relevant information as prescribed by TFDA.

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