- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > clinical pharmacology and research
- Palabras clave > clinical research
- Palabras clave > clinical trials
- Palabras clave > clinical trials - submission, review and evaluation of applications
- Palabras clave > clinical trials in humans
- Palabras clave > ethical practices and standards
- Palabras clave > GCP for trials on pharmaceutical products
- Palabras clave > Good Clinical Practice (GCP)
- Palabras clave > safety testing
(2009; 50 pages)
Clinical trials are systematic research studies conducted on human participants aimed at determining the safety and effectiveness of new or unproven therapies. They are specifically designed to find better ways to prevent, detect, diagnose or treat diseases and/or conditions and to answer scientific questions.
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.
These guidelines have therefore been developed so as to provide guidance on current minimum standards that are required for authorization of clinical trials involving drugs, medical devices or herbal drugs in Tanzania. It articulates among other things, application procedures, good clinical practice (GCP) requirements and ethical principles for medical research involving human participants.
The current edition has been improved to incorporate new requirements which include clinical trial application form (CTA) which replaces PBF 19 Form required in the previous edition. It has also added requirements for qualifications & responsibilities of investigators and monitors, requirements concerning informed consent and procedures for trial amendments.
Others include reporting of serious adverse events (SAEs)/suspected unexpected serious adverse drug reactions (SUSARs), requirements concerning data safety monitoring board (DSMB) or alternatively known as data monitoring committee (DMC), submission of progress reports, procedures for termination of clinical trials and a snapshot on inspection of trial sites.
Various forms and tools have also been attached as appendices to aid in the application process. These should be filled in and submitted together with the documentation as specified in the guidelines.