Posted On:: Apr, 03 2019
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TMDA achieved a stable and well functioning system for medical products, the first to be confirmed to reach WHO Maturity Level Three (ML-3) in Africa.

Tanzania Medicines and Medical Devices Authority becomes the first to reach level 3 of the WHO benchmarking programme

The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products. In order to strengthen their regulatory functions, the benchmarking of the Tanzania Medicines and Medical Devices Authority (TMDA) which has been established following the transfer of functions on regulation of food and cosmetic products from the then TFDA to Tanzania Bureau of Standards (TBS) and the Zanzibar Food and Drug Agency (ZFDA) was done in May by a team of Technical officers from WHO HQ and Country Offices and experts from some countries in Africa and Europe.

Benchmarking is done to identify strengths as well as areas for improvement. At the same time, development of an Institutional Development Plan (IDP) to build on strengths and address areas for improvement is done. Afterwards, the WHO will provide technical support in the implementation of the IDP followed by continued monitoring of progress and outcome/impact.

From the benchmark results, TMDA has been classified into maturity level 3 according to its ability to perform the required regulatory functions as follows:

Maturity level 1: The agency has some elements of regulatory system existing

Maturity level 2: Evolving national regulatory system that partially performs essential regulatory functions

Maturity level 3: Stable, well-functioning and integrated regulatory system

Maturity level 4: Regulatory system operating at advanced level of performance and continuous improvement

TMDA was previously benchmarked in 2011 and 2016 by a WHO team of experts for its regulatory functions and in the implementation of recommended activities in the medicines and vaccines regulation as part of the IDP. The benchmarking this time was part of the continuous monitoring and follow-up to evaluate the level of IDP implementation by 2018 and to determine the current level of its maturity.

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