About TMDA Laboratory

Dr. Danstan Hipolite Shewiyo. Director, Laboratory services

Legal Status

TMDA Quality Control Laboratory is established under section 14(1) of the Tanzania Medicines and Medical Devices Act, Cap. 219, to carry out analysis of regulated products.

TMDA has three laboratories in Dar es Salaam, Mwanza and Dodoma. The laboratories are located at TMDA sub Head office and Zonal offices in Dodoma and Mwanza. These laboratories are complemented by 25 medicine quality assurance centers which are equipped with minilab kits. The centers are stationed at ports of entries, zone offices and some regional referral hospitals across the country.

Test results generated enable the Authority to make evidence-based regulatory decisions.

Roles and Functions of TMDA Laboratory

The laboratory is mandated to perform the following functions:

  1. Analysis of drugs, medical devices, herbal drugs, drug adjuvant, packaging materials, systemic diagnostic agents and any other products that may be deemed to constitute a drug product;
  2. Conducts research and training; and
  3. Carry out other function as determined by the Authority.

Laboratory Quality Policy Statement

TMDA top management is committed to complying with the requirements of the ISO/IEC 17025:2017 and WHO Good Practices for Pharmaceutical Quality Control Laboratories and ensures that laboratory services rendered to its customers are always offered by competent laboratory personnel in an impartial manner.
Management provides resources for implementation and continually improves effectiveness of our Quality Management System by ensuring that personnel within the Laboratory are familiar with the quality documentation and implement consistently policies and procedures in their work.

The Laboratory is committed to:

  1. Maintain WHO Prequalification;
  2. Meet needs of customers which include the provision of timely and accurate results;
  3. Provide quality analytical results so as to assist in regulatory decision making; and
  4. Meet business objectives of the TMDA.

Prequalification Status

The laboratory is prequalified since January 2011 after assessment and compliance to WHO requirements and is therefore among the fifty-seven (57) prequalified quality control laboratories ( List of WHO prequalified laboratories by June, 2021).

  • International recognition
  • Increased customer confidence
  • Demonstration of competence
  • Produce accurate and reliable results
  • Increased revenue