Abstract

DRUG REGISTRATION PROCESS FOLLOWED IN TANZANIA

J. Manoj Krishna*, D. Nagarjuna Reddy, M. V. Nagabhushanam, Brahmaiah Bonthagarala and G. Ramakrishna

Abstract

The Tanzania Food and Drugs Authority (TFDA) was established under the Tanzania Food, Drugs and Cosmetics Act, 2003 with the mission of protecting and promoting public health by ensuring quality, safety and effectiveness of food, drugs, cosmetics and medical devices. In view of unique nature of pharmaceutical products and its raw materials, the Tanzania Food, Drugs and Cosmetics Act, 2003 provides for control of importation and exportation of pharmaceutical products or any substance used for the manufacture of pharmaceuticals. The law requires that any person dealing with importation of the products must be registered by TFDA and the imported pharmaceutical products must also be registered or approved by the Authority. These are the fundamental requirements for authorizing importation of pharmaceutical products and raw materials into the Tanzanian market. The guidelines are therefore reviewed in order to cope with the new developments in terms of requirements for importing or exporting pharmaceutical products and raw materials. The reviewed guidelines currently entitled as “Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials, 2011” provides for guidance on the information and documentation required in an application submitted to TFDA by an importer or exporter of pharmaceutical products and raw materials.

Keywords: Tanzania Food and Drugs Authority (TFDA), Drug Registration Process, Pharmaceutical Products.