TMDA is one of the institutions that have registered a couple of notable achievements. Some of these are listed below:
- Setting up a Quality Management System (QMS) that has attained ISO 9001:2015 certification.
- Establishing and implementing a laboratory QMS for medicines that has attained WHO prequalification.
- Reaching WHO Maturity Level 3 status for setting up a robust medicines regulatory system (the first of its kind in Africa).
- Designated as the Center of Excellence for Registration of Medicines in Africa as part of the African Medicines Regulatory Harmonization (AMRH) initiative.
- Creating a Clinical Trials Registry for recording and monitoring clinical trials conducted in the country.
- Establishing mobile and patient reporting systems for safety monitoring of medicines.
- Creating a post marketing surveillance system that ensures existence of products that are of good quality, efficacious and safe for human consumption.
- Being one of few regulators in Africa to establish a medical devices and diagnostics control system.
- 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.
- Establishing eight (8) zone offices to serve customers residing in remote areas and improve service delivery.
- Building a state of the art office and laboratory in Mwanza and Dodoma regions to serve customers in the lake and central zones.
- Obtaining clean Audit Certificates since its establishment.
- Consistently contributing to the treasury, 15% of gross income and 70% of excess capital generated from fees collected out of services rendered.
- Establishing an institution including a laboratory that offers training to many other regulators in Africa.
- Maintaining a good workforce, efficient organizational culture with very low attrition rate.