DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

  • Achin Jain JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.
  • M P Venkatesh M P JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.
  • Pramod T.M. Kumar JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India

Abstract

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
 

Keywords: Tanzania, TFDA, New drug, Disposal, Import, Export and Variation.

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Author Biographies

Achin Jain, JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.

JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.

M P Venkatesh M P, JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.

JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India.

Pramod T.M. Kumar, JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India

JSS College of Pharmacy, JSS University, S.S. Nagar, Mysore-570015, Karnataka, India

References

1. Tanzania Food and Drug Authority [Internet].
Tanzania: Food and Drug Authority;2014[cited 2015
March 21]. Available from:
http://www.tfda.or.tz/function.php
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%20DG%20APPROVED%2012%2009%202012.pdf
3. Application Guidelines for Variation of Registered
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Tanzania: TFDA, 5th edition, 2008 Aug [cited 2015
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4. Guidelines for Importation and Exportation of
Pharmaceutical Products and Raw Materials, TFDA
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http://www.tfda.or.tz/index.php?option=com_phocado
wnload&view=category&id=22&Itemid=300#
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wnload&view=category&id=22&Itemid=300#
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How to Cite
Jain, A., M. P. Venkatesh M P, and P. T. Kumar. “DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 2, June 2015, pp. 1-7, doi:10.22270/ijdra.v3i2.12.