DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE
In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,
safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuring
safety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.
The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to the
fulfilment of the needs of the less privileged rural population.
Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at an
annual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market is
highly dependent on imports, which account for around 75% of the total pharmaceutical market.
The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up by
the TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally
Tanzania: Food and Drug Authority;2014[cited 2015
March 21]. Available from:
2. Guidelines on Submission of Documentation for
Registration of Human Medicinal Products, TFDA
th edition, 2012 Aug [cited 2015 March
23]. Available from:
3. Application Guidelines for Variation of Registered
Human Medicinal Products, TFDA [Internet].
Tanzania: TFDA, 5th edition, 2008 Aug [cited 2015
March 27]. Available from:
4. Guidelines for Importation and Exportation of
Pharmaceutical Products and Raw Materials, TFDA
[Internet]. Tanzania: TFDA, 2th edition, 2011 [cited
2015 March 28]. Available from:
5. Guidelines for safe disposal of unfit medicines and
cosmetic products, TFDA [Internet]. Tanzania: TFDA,
st edition, 2009 April [cited 2015 March 28].
6. New Fees and Charges for Medicines, Cosmetics and
Medical Devices [Internet]. Tanzania: TFDA, 2010
Oct [cited 2015 March 30]. Available from:
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