TMDA Guidelines

  • Guidelines on Good Review Practices, April, 2023 Download
  • Guidelines on Processing of Applications for Registration of Medicinal Products through Non-Routine Procedure, April, 2023 Download
  • Guidelines for Emergency Use Authorization of Medicinal Products, April, 2023 Download
  • Guidelines for Surveillance of Adverse Events Following Immunization, Second Edition, December 2022 Download
  • Guidelines for Emergency Use Authorization of Medicinal Products, September, 2022 Download
  • Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, January 2021 Download
  • National Guidelines for Monitoring Medicines, Third Edition, June 2018 Download
  • Guidelines for Application to Conduct Clinical Trials in Tanzania,Third Edition, June 2017 Download
  • Guidelines for Reporting Safety Data in Clinical Trials,First Edition, May 2011 Download
  • Guidelines for Conducting Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) Inspection, First Edition June 2017 Download
  • Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania, First Edition, December 2010 Download
  • Guidelines on Variations of Registered Vaccines Download
  • Quality Information Summary (QIS) Download
  • Compendium Guidelines for Marketing Authorization of Medicinal Products Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Herbal Medicinal Products Download
  • Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptics and Disinfectants) Products, August 2020. Download
  • Guidance for Production of Alcohol-Based Hand Sanitizers Under Public Health Emergency Preparedness, April 2020. Download
  • Guidelines on Submission of Documentation for Registration of Immunological Veterinary Products, March 2020 Download
  • Guidelines on Submission of Documentation for Registration of Veterinary Medicinal Products, March 2020. Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products, March 2020. Download