Checklist

Checklist

CTD Assessment Workspace

Complete risk-based reviews across CTD Modules 1–5, including API and drug-product manufacture, comparative bioequivalence and dissolution.

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Applicant self screening checklist before submission of medicines
 50.01 KB
 10-18-2025

This is for self-screening of the documentation in support of the registration of Medicines. It should be signed and stamped by the Marketing Authorization Holder

Checkilst requirement for the documentation for registration of Medicinal Products
 133.42 KB
 10-18-2025

This is simplified guidance for the documentation for the registration of Medicinal products, for main content visit the compendium guidelines available at TMDA through https://www.tmda.go.tz/publications/42

Checklist requirement for the documentation for registration of Medical devices Class B, C, and D
 148.12 KB
 10-18-2025

This is summarized requirement for the documentation for registration of Class B, C, and D medical devices. 

Requirement for the documentation for the registration of Class B,C and D IVDDs
 301.91 KB
 10-18-2025

This is summarized requirement for the documentation for registration of Class B, C, and D medical IVDDs

BCS CLass Drug List
 152.89 KB
 12-13-2025

The Biopharmaceutics Classification System (BCS) classifies drug substances into four classes based on their solubility and intestinal permeability: