These Guidelines pertain to applications for conducting clinical trials of a medicine in human participants in Zimbabwe in line with the Medicines and Allied Substances Control Act (Chapter 15:03). They contain guidance on pre-submission enquiries, documentation such as study protocol, investigator’s brochure, pharmacy plan, insurance, data and safety monitoring and other relevant documents and information. It explains the application review and authorization process and post authorization monitoring requirements including Good Clinical Practice inspections.
زيمبابوي · 2021-07-01