TFDA Guidelines

  • Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutics Products Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Human Vaccines 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
  • Guidelines on Therapeutic Equivalence Requirements Download
  • Guidelines on Submission of Documentation for Registration of Medicines Download
  • Guidelines on Stability Testing Requirements for APIs and FPPs Download
  • Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products Download
  • Guidelines on Procedural Aspects for Application for Marketing Authorization for Human Medicinal Products Download
  • Guidelines on List of Standard Terms for Medicinal Dosage Forms and Routes of Administration Download