Notable Achievements

TMDA is one of the institutions that have registered a couple of notable achievements. Some of these are listed below:

  1. Setting up a Quality Management System (QMS) that has attained ISO 9001:2015 certification.
  2. Establishing and implementing a laboratory QMS for medicines that has attained WHO prequalification.
  3. Reaching WHO Maturity Level 3 status for setting up a robust medicines regulatory system (the first of its kind in Africa).
  4. Designated as the Center of Excellence for Registration of Medicines in Africa as part of the African Medicines Regulatory Harmonization (AMRH) initiative.
  5. Creating a Clinical Trials Registry for recording and monitoring clinical trials conducted in the country.
  6. Establishing mobile and patient reporting systems for safety monitoring of medicines.
  7. Creating a post marketing surveillance system that ensures existence of products that are of good quality, efficacious and safe for human consumption.
  8. Being one of few regulators in Africa to establish a medical devices and diagnostics control system.
  9. Establishing an IT infrastructure which is very effective including offering online services to customers such as online import application system and electronic submission system for product dossiers.
  10. Establishing 7 zone offices to serve customers residing in remote areas and improve service delivery.
  11. Building a state of the art office and laboratory in Mwanza region to serve customers in the lake zone.
  12. Obtaining clean Audit Certificates since its establishment.
  13. Consistently contributing to the treasury, 15% of gross income and 70% of excess capital generated from fees collected out of services rendered.
  14. Establishing an institution including a laboratory that offers training to many other regulators in Africa.
  15. Maintaining a good workforce, efficient organizational culture with very low attrition rate.