TMDA Guidelines

  • Guidelines on Variations of Registered Vaccines Download
  • Guidelines for Reporting of Safety Data in Clinical Trials Download
  • Guidelines for Application to Conduct Clinical Trials in Tanzania Download
  • Guidelines for Surveillance of Adverse Events Following Immunization Download
  • Guidelines for Application to Conduct Clinical Trials in Tanzania Download
  • Compendium of Medicines Evaluation and Registration for Medicines Regulation Harmonization for EAC, September 2014. Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products, March 2020. Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutics Products, March 2020. Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Human Vaccines, March 2020. Download
  • Guidelines on Variations on Registered Medicinal Products Download
  • Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania Download
  • Guidelines for conducting GCP and GCLP Inspection Download
  • GMP Guidelines for VET Medicinal Products Download
  • GMP EAC Compendium Download