The TFDA regulates and ensures the quality, safety and efficacy of food, drugs, medical devices and cosmetics in Tanzania. Regarding East Coast Fever (ECF), the TFDA's role includes pre-market evaluation and registration of ECF vaccines to ensure their quality, safety and efficacy. It also conducts post-market monitoring and regulates the import and export of ECF vaccines. Currently, the only ECF vaccine registered in Tanzania is the Muguga cocktail vaccine manufactured in Kenya, though a new vaccine application is under review.

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The Role of TFDA In The Control Of East Coast Fever
Oceanic Bay Hotel, Bagamoyo.
September 29, 2015
Dr. Rukia Saidi
Drug registration Officer
Tanzania Food and Drugs Authority

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Outline of Presentation
• Introduction
• Role of TFDA in General
• Role of TFDA in control of ECF
• ECF vaccines registered by TFDA

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IntroductionIntroduction
• TFDA is a Statutory organization under the
MoHSW
• It has been established under sect. 4 of the Food,
Drugs and Cosmetics Act, 2003
• Mission: Protection and promotion of public
health by ensuring quality, safety and effectiveness
of medicines , food, cosmetics and medical devices
• Vision: To be the leading African regulatory
Authority in ensuring safe, quality and effective
food, medicines, cosmetics and medical devices for
all.

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Roles of TFDA
►TFDA is responsible for regulating and ensuring
quality, safety & efficacy of food, drugs (human,
veterinary, herbal and vaccines), medical
devices & cosmetic products through:
►Evaluation & registration of such products
 Applicant need to submit a dossier which contains
information on how the product has been manufactured
 TFDA will go through this document to see if the
information provided have established the quality, safety
and efficacy of the product
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Roles of TFDA…………..
►Registration & licensing of premises
 The premise which store drug should be registered by
TFDA in order to make sure that they comply with
requirement for storage of medicinal product
►GMP inspection of drug and vaccine
manufacturers
 To verify if the manufacturing site follow the GMP rules
►Import and export control
►Monitoring of adverse drug reactions
(ADRs) 5

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Role of TFDA in control of ECF
• Pre-market evaluation of ECF Vaccine. This
is intended to determine whether the
vaccine's:
– Quality is adequately controlled to ensure batch
to batch consistence
– Adequately tested for safety and efficacy
– Properly labelled and accompanied by correct
and adequate directions for use and handling of
the product to minimize medication errors
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Role of TFDA in control of ECF…………
• Post marketing analysis of vaccine
• Import and export control of vaccine
• Premise registration and licensing
In general TFDA aimed to facilitate access
of quality ECF vaccine.
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ECF vaccine registered by TFDA
• Currently there is only one vaccine for ECF
which have been approved by TFDA which
is Muguga cocktail-ECF vaccine (Trivalent –
ECF vaccine). Manufactured by
International Livestock Research Institute
(ILRI), Nairobi-Kenya
• We have also received new application for
registration ECF vaccine. It is currently
under assessment
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Conclusion
All veterinary products must be registered by
TFDA before being sold/ distributed in
Tanzania.
Therefore TFDA is protecting the health of
animals by ensuring that the drugs/vaccine
which will be used to treat/vaccinate the
animal are of good quality, safety and
efficacy
This is a legal requirement
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Thank you