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Tanzania Food and Drugs Authority (TFDA) is a regulatory body under the Ministry of Health and Social Welfare which is responsible for regulating the quality and safety of food, drugs, cosmetics and medical devices. more about TFDA
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Now you can register your Clinical Trial ( i.e. Protocol Registration ) online through the Tanzania Clinical Trial Registry (TzCTR) system.
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Have you suffered an adverse drug reaction? If so please consult your healthcare provider to fill the ADR form on-line. or  download the form, have it filled by your healthcare provider and send it to us.
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The authority provides education to the public about food, drugs, cosmetics and medical devices. For more information   Click here  
 

Tanzania Food and Drugs Authority Regulations
THE FOOD, DRUGS AND COSMETICS (FEES AND CHARGES) REGULATIONS.
  1. 2005 is gazetted on 30 December 2005. These Regulations may be cited as the Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2005; These Regulations shall apply in all areas to which the Act applies and shall have effect on the date of publication in the Gazette.
  2. TFDA is responsible for 'National-wide compliance and enforcement activities' enabling consistency of approach across the spectrum of regulated products. The Authority's core functions are compliance monitoring, and compliance verification, supported by establishment licensing of food manufacturing premises, drugs, herbal drugs, medical devices, and laboratory analysis. Click Here to get Enforcement Compliance Policy
  3. REGULATION OF ADDO AND PHARMACY BUSINESSES
    Tanzania Food and Drugs Authority (TFDA) is reviewing Accredited Drugs Dispensing Outlets (ADDO) regulations of 2004 and Pharmaceuticals and Poisons regulations of 1990. The objective of this review is to improve the regulation of pharmaceutical premises in the country with ultimate outcome of improve the quality of pharmaceutical care. The reviewed regulations will be known as (Tanzania Food, Drugs and Cosmetics (Pharmaceutical Business Standards) Regulations.

In view of this, TFDA conducted pharmaceutical personnel meeting on 21 December 2006 at Ubungo Plaza, Dar es Salaam whereby more than 200 participants attended and discussed various issues related to ADDO Program and regulations of Pharmaceutical Businesses. It was agreed during that meeting that a 6-weeks duration should be given for stakeholders to provide their comments.

Dear stakeholder, you are hereby requested to read the document and submit your comments to TFDA as soon as possible so that they can be consideration during finalization of the document. Please submit your comments, quoting the above heading, to:

Director General
TFDA
P.O. Box 77150
Dar es salaam
Tanzania
Fax 022 2450793
Email info@tfda.or.tz
GUIDELINES
  1. Guidance on the Conduct of Clinical Trials in Paediatric Population in Tanzania.
    (Posted: 30th December, 2011)

  2. Guidelines for Assuring Safety of Preventive Chemotherapy.
    (Posted: 30th December, 2011)

  3. Guidelines for Reporting of Safety Data in Clinical Trials.
    (Posted: 25th October, 2011)

  4. Guidelines for Insurance and Indemity of Clinical Trials in Tanzania.
    (Posted: 25th October, 2011)

  5. Tangazo la Viwango Vipya vya Ada na Tozo 2011/2012.
    (Imetolewa: 23 Septemba, 2011)

  6. Fomu ya uambuzi wa dawa za mitishamba zilizosindikwa.

  7. Guideline for Application of Permit to Deal with Medical Devices Business.

  8. Guidelines for Good Distribution Practice.

  9. Application for registration of food.

  10. Application for registration drugs.

  11. Application for registration of herbal drugs.

  12. Application for registration of cosmetics.

  13. Application for registration biologicals.

  14. Food Importation guidelines.

  15. Dealing with part 1 poison shop(Pharmacy).

  16. Donation Guidelines.

  17. Monitoring and reporting adverse drugs reactions.

  18. Dealing in Controlled drugs.

  19. Food borne disease surveilance.

  20. Importation Pharmaceutical.

  21. registration of verternary medical products.

  22. Good manufacturings practise.
 
 
 
 
  1. Launch of Medicines Registration Harmonization (MRH) in EAC.
    (Posted: 23rd March, 2012)

  2. Taarifa Kuhusu Uwepo wa Dawa Bandia ya Kutibu Ugonjwa wa Malaria iitwayo ELOQUINE (Quinine Sulphate 300mg USP).
    (Imetolewa: 24 February, 2012)

  3. Mkutano wa Wamiliki wa Maduka ya Dawa Baridi Mkoani Dar es Salaam, tarehe 17 January 2012.
    (Posted: 16th January, 2012)

  4. Announcement to all Parties Conducting Clinical Trials and those Providing Preventive Chemotherapy in Tanzania.
    (Posted: 30th December, 2011)

  5. Clarification on Inspection of Overseas Pharmaceutical Manufacturing Facilities by TFDA.
    (Posted: 21st December, 2011)

  6. Announcement to All Parties Involved or Conducting Clinical Trials in Tanzania.
    (Posted: 25th October, 2011)

  7. a) Utaratibu Mpya wa Kulipia Huduma za TFDA Kufanyika Kupitia Benki.
    (Imetolewa: 07 Oktoba, 2011)

    b) New Payment Systems for TFDA Services Through Bank Account.
    (Posted: 7th October, 2011)

  8. Tahadhari ya Uwepo wa Dawa Bandia kwenye Soko.
    (Imetolewa: 27 Septemba, 2011)

  9. Tangazo la Viwango Vipya vya Ada na Tozo 2011/2012.
    (Imetolewa: 23 Septemba, 2011)

  10. Taarifa kwa Umma Kuhusu Usalama wa Samaki Walioingizwa Nchini kutoka Japan, Tarehe 24, July 2011.
    (Imetolewa: 13 Septemba, 2011)


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