Notable Achievements
2003: Establishment of TFDA
TFDA was established after the enactment by Parliament of the Tanzania Food, Drugs and Cosmetics Act (Chapter 219).
2004: Expansion of TFDA Laboratory in Dar es Salaam
The TFDA expanded its Quality Control Laboratory building in Dar es Salaam including equipping the same with state-of-the-art analytical instruments, machines and equipment.
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2005: Innovation and Successful implementation of Accredited Drug Dispensing Outlet (ADDO) Programme
In protecting public health, the Authority innovated a regulatory system to mitigate the mushrooming of informal markets with unlicensed drug outlets and therefore approved the establishment of accredited drug outlets for selling medical products, a lesson that has been learnt by other National Regulatory Agencies (NRAs) in Africa.
2006: Launching and Operationalisation of Zone Office in Mwanza
The first Mwanza Zone Office was established with the overall aim of bringing regulatory services closer to the people. With this necessity, since 2006, eight (8) zone offices have been established to carry out among other functions effective inspection and enforcement roles.
2007: Completion of the TFDA Headquarters’ Office building in Dar es Salaam
The construction of the headquarters building in Dar es Salaam was completed and commissioned to start operations.
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2007: TMDA SACCOS
TMDA SACCOS was established.
2008: The TFDA Headquarters’ Office building in Dar es Salaam launched
The TFDA Head Office building was officially launched by Hon. Amani Abeid Karume – President of the Revolutionary Republic of Zanzibar.
2009: Attaining ISO certification
The Authority attained ISO 9001: 2008 certification for setting up an effective QMS that responds to customer satisfaction. The standard was later on updated to ISO:9001: 2015 in 2015.
2010: Awarded Best Managed Institution in Tanzania
The Authority was ranked to be the best-managed institution in Tanzania amongst Ministries, Departments and Agencies for the years 2010 and 2011 consecutively.
2011: Attaining WHO Prequalification for the TFDA Laboratory
The TFDA medicines laboratory attained WHO prequalification after a successful inspection conducted by WHO. After becoming WHO-prequalified, the laboratory provides reliable analytical testing services to customers dealing with medical products. Test results generated enable the Authority to make evidence-based regulatory decisions and are reliable internationally.
2012: Designation as the Centre of Excellence for Registration of Medicines in Africa
The Authority was designated as the Centre of Excellence for Registration of Medicines in Africa as part of the African Medicines Regulatory Harmonisation (AMRH) initiative. While embracing a broad spectrum of expertise and specialities, TMDA is in a unique position to address some of the most challenging and pressing issues in the regulatory landscape in Africa.
2013: Establishment of Centre of Excellence for Laboratory Training to other NRAs in Africa
TFDA had been constantly providing scientific and analytical on job training to other NRAs in Africa. It strives to be a valued partner that forges strategic linkages with international agencies that share its commitment to public health protection.
2014: Launching of an Integrated Management Information System (IMIS)
IMIS was officially launched and commissioned to allow for introduction of online services.
2015: Automation of Regulatory Services
The Authority established an IT infrastructure which is very effective, including offering online services to customers such as an online import application gateway and electronic submission system for product dossiers. The system has attracted other NRAs within Africa to visit and learn on how to improve their e-commerce in regulatory services.
2016: Completion of Lake Zone Office and Laboratory in Mwanza
The construction of the Lake Zone office and Laboratory was completed including procurement of modern analytical equipment and instruments. This expanded the scope of laboratory services provided by the Authority, thereby boosting its capacity to analyse samples
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2018: Attainment of WHO Maturity Level 3; the first of its kind in Africa
The Authority was the first NRA in Africa to attain Maturity Level (ML) 3 for setting up a robust medicines regulatory system in 2018. This status made Tanzania to become the first WHO member state in Africa to reach this advanced stage in medicines regulation.
2018: Quality Control Laboratory Attains WHO ML4
The Dar es Salaam Quality Control Laboratory attained Maturity Level 4 (ML4) after a successful WHO inspection. It was the first Quality Control Laboratory to attain WHO ML4 for testing pharmaceutical products in Africa.
2019: Change of name from TFDA to TMDA
The name of Tanzania Food and Drugs Authority (TFDA) was changed to Tanzania Medicines and Medical Devices Authority (TMDA) after amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 and the Standards Act, Cap 130. Following the amendments, the regulation of food products and cosmetics was shifted from TFDA to the Tanzania Bureau of Standards (TBS). The amendment was done through the Finance Act of 2019
2020: Completion of TMDA Zone Office and Laboratory in Dodoma
The construction of the Central Zone Office and Laboratory was completed including procuring modern analytical equipment and instruments to allow for effective laboratory services.
2021: TMDA Assigned to Regulate Tobacco Products
Under Section 18 of the Tobacco Products (Regulations) Act (Chapter 121), the Minister for Health designated the TMDA as the Regulator of tobacco products.
2022: TMDA Establishes Mobile and Patient Reporting Systems for Safety Monitoring of Medicines
The Authority launched the patient safety reporting system to allow for effective monitoring of safety of medicines circulating on the market.
2023: Ratification of AMA Treaty
The treaty for establishment of the African Medicines Agency was ratified by the Parliament of the United Republic of Tanzania.
2023: Construction of Incinerator
The construction of incinerator for disposal of unfit products started.
2003 - 2023: Obtaining Clean Audit Certificates
The Authority obtained Clean Audit Certificates issued by the Controller and Auditor General (CAG) for optimal and effective financial and institutional management.
2003 - 2023: Registration of Products
Number of registered medicines increased from 591 in 2013 to 891 in 2023 Number of registered medical devices and diagnostics increased from 265 in 2013 to 2,804 in 2023
2003 - 2023: Registration of Premises
Number of registered pharmaceutical premises increased from189 in 2013 to 4,428 in 2023 Number of registered medical device premises increased from 0 in 2013 to 2,443 in 2023
2003 - 2023: Import and Export Permits Issued
Number of import permits issued per-annum increased from 3,952 in 2013 to 10,257 in 2023 Number of export permits issued per-annum increased from 82 in 2013 to 824 in 2023
2003 - 2023: Authorization of Clinical Trials
Number of authorized clinical trials increased from 63 in 2013 to 208 in 2023
2003 - 2023: GMP Inspection and Quality Audit
Number of pharmaceutical manufacturing facilities inspected for GMP compliance increased from 72 in 2013 to 116 in 2023 Number of medical devices and diagnostics manufacturing facilities audited increased from 0 in 2013 to 65 in 2023.
2003 - 2023: GCP Inspection
Number of clinical trials inspected for GCP compliance increased from 72 in 2003 to 116 in 2023
2003 - 2023: ADR and AEFI Reporting
Number of ADRs reported increased from 2,263 in 2013 to 10,921 in 2023 Number of AEFIs reported increased from 2004 in 2013 to 16,963 in 2023
2003 - 2023: Laboratory Analysis
Number of samples analyzed in the laboratory per-annum increased from 1,305 in 2013 to 1,553 in 2023.
2003 - 2023: Human Resources Capacity
Number of permanent and pensionable employees increased from 62 in 2003 to 349 in 2023
2003 - 2023: Customer Satisfaction Level
External customer satisfaction level increased from 74 in 2014 to 75 in 2020 Internal customer satisfaction level increased from 68 in 2014 to 80 in 2020
2003 - 2023: Communication Platforms
TMDA Website launched ¾ Social media accounts (facebook, twitter (now X) and instagram) launched ¾ TMDA TV online launched ¾ TMDA Toll free number launched ¾ TMDA na Jamii Programme launched
2003 - 2023: Financial Stability
The financial position of the Authority has been improved yearly due to collection arised from the fees and charges obtained through services rendered hence contributing 15% of its gross income and 70% of excess capital as required by the office of the Treasurer Registrar.
2003 - 2023: Land Acquisition
Plot located in Arusha Plot located in Mbeya Plot located in Mwanza Plot located in Dodoma Plot located in Pwani Plot located in Tabora Plot located Mtwara Plot located in Geita Plot located in Morogoro
2003 - 2023: Performance Appraisal Systems
The open performance appraisal system (OPRAS) was launched. The TFDA/TMDA Annual Staff Appraisal (TASA) system was launched.
2003 - 2023: Promotion of Domestic Manufacturers
TMDA contributed in increasing the number of domestic manufacturers from 2013 to 2023 by creating enabling business environment as hereunder: ¾ Pharmaceutical manufacturers from 9 to 17 ¾ Medical Device and Diagnostics manufacturers 0 to 41
2003 - 2023: TMDA Staff Recruited in International Organizations
TMDA staff who have been recruited or seconded to work in international organizations: S/N Name Organization Dr. Margareth Ndomondo Sigonda NEPAD Mr. Hiiti B. Sillo WHO Ms. Agnes S. Kijo WHO Mr. Akida Khea WHO Dr. Alex Nkayamba WHO Ms. Alambo Msussa WHO Mr. Sunday Kisoma WHO Mr. Alex Juma NEPAD Ms. Jeniva Jasson WHO Mr. Augustine Massawe ECSA Dr. Henry Irunde EAC Dr. Shani Maboko Rwanda -