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