The regulation of food and medicines began prior to the establishment of TFDA in July 2003.
During that period, food and medicinal products were regulated through different laws enforced by departments and divisions under different Ministries. The regulation of such products was later done under Professional Boards.
Due to rapid growth and advancements in science and technology as well as free market forces, the Government through The President’s Office - Public Service Management (PO-PSM), decided to establish executive agencies. This move was geared towards improving public services to meet customer needs and expectations. In this respect, a number of executive agencies were established including TFDA in accordance with the Executive Agencies Act, Cap 345 of 1997 and its amendments of 2009.
TFDA is mandated to regulate the quality, safety and efficacy of food, medicines, cosmetics and medical devices. Such functions are also provided under the Tanzania Food, Drugs and Cosmetics Act, Cap 219. TFDA began its operations on 1st July 2003. Since its inception, TFDA has attained notable achievements in regulating the quality, safety and efficacy of food, medicines, cosmetics and medical devices. Amongst its achievements, TFDA has developed robust systems and put in place guidelines for registration of products, inspection and surveillance as well as laboratory analysis of product samples prior to market authorization.
TFDA has also set up systems for pharmacovigilance and food borne diseases surveillance as well as a clinical trials control system for medicines and medical devices. The main objective is to protect the health of consumers by ensuring that only products that meet quality, safety and efficacious specifications circulate in Tanzania market.
Furthermore, TFDA has managed to develop and implement Quality Management System (QMS) in order to deliver quality and consistent services to its customers. In view of implementing QMS, TFDA attained ISO 9001: 2008 certified since 2008/09 in areas of food, medicines, cosmetics and medical devices regulatory systems. The certification was done by ACM Limited of UK.
In 2006, TFDA developed and implementing a Client’s Service Charter which was reviewed in 2012 in consultation of stakeholders with the aim of improving efficiency and effectiveness in service delivery and meeting customer needs and expectations without compromising quality, safety and efficacy of regulated products.
In addition, TFDA has also managed to construct a new building at its headquarters in Dar es Salaam along Mandela Road, Mabibo External. Seven Zone Offices have also been opened up in Arusha, Mwanza, Mbeya, Dar es Salaam, Dodoma, Mtwara and Tabora regions in order to bring TFDA services in close proximity to customers.
Conversely, TFDA has also managed to expand its laboratory building including procurement of state of the art analytical equipment and instruments. Above all, much needed training had been conducted to all laboratory staff. Such improvement has enabled the laboratory to be prequalified by the World Health Organization (WHO) in January, 2011. The Microbiology and Food laboratories have been accredited by the Southern African Development Cooperation Accreditation System (SADCAS) to ISO/IEC 17025:2005 standards. This implies that analytical results obtained from the TFDA laboratory are internationally recognized and accepted.
The Authority has created a robust financial management system which has facilitated effective collection of fees and charges as a result, TFDA’s financial statements and accounts had been audited by the Controller and Auditor General (CAG) and obtained a clean audit report for 11 consecutive years.
Despite the successes attained, TFDA is still facing challenges in executing its functions ranging from existence of substandard and counterfeit products in the market which pilferage through unauthorized borders to lack of harmonized regulatory systems in the East African Community (EAC) and Southern Africa Development Community (SADC) regions.
Nevertheless, TFDA is responsible for improving inspection activities and public education to all Stakeholders in order to achieve its vision of becoming a leading African regulatory Authority in ensuring safe, quality and effective food, medicines, cosmetics and medical devices for all.
It is my expectation TFDA will significantly strengthen regulatory systems by addressing the existing and envisaged challenges in order to meet its mission of protecting and promoting public health by ensuring the quality and safety of food, medicines, cosmetics and medical devices.
‘Let’s join hands to combat counterfeit food, medicines, cosmetics and medical devices to protect our health’
Hiiti B. Sillo