- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - submission, review and evaluation of applications
- Keywords > clinical trials in humans
- Keywords > clinical trials registration
- Keywords > code of conduct
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > Research Ethics Committee (REC)
- Keywords > safety
(2008; 51 pages)
The Pharmaceutical Act (No. 14) of 2004 requires that Clinical trails intended to be conducted in Zambia meet acceptable standards of Good Clinical Practice (GCP).
These guidelines outline the information required by the Regulatory Authority from sponsors and applicants wishing to conduct clinical trials as well as to define the evaluation process for the conduct of clinical trials. These guidelines also indicate the order of the material to be submitted and the minimum requirements for conducting clinical trails.
These guidelines are not intended as a comprehensive guide on Good Clinical Practice (GCP) and should be read in conjunction with relevant international GCP guidelines. These guidelines have been prepared by the Pharmaceutical Regulatory Authority (PRA) in accordance with the WHO/SADC Guidelines.
Compliance to these guidelines in the submission of applications will facilitate the speedy processing and evaluation of the applications and subsequent approval of conduct of clinical trails...