Tanzania : Drugs
Clinical Trial Data Requirements
Requirements to conduct clinical trials are outlined in Guidelines for Application to Conduct Clinical Trials in Tanzania. The application should include:
-Application form signed and stamped.
-General investigational plan.
-Plans for capacity building (training and updating staff involved in the trial).
-Protocol (study protocol, ethics committee authorization, informed consent forms for participants).
-Data sheet with prescribing information.
-Declarations by sponsor, investigators, and monitors in the format specified in guidelines (Appendices 2-4).
-Financial declaration by sponsor and or principal investigator in the format specified in guidelines (Appendix 5).
-Certified copy of study participants insurance.
-Ethical clearance or copy of acknowledge of study protocol submission from the National Ethics Committee.
-CV of investigators (Appendix 6 for format).
-Investigational medicinal product dossier.
Requirements of the clinical trial study protocol are also outlined in the Guidelines for Application to Conduct Clinical Trials handbook. Specific requirements on general information, background information, trial objectives and purpose, trial design, study participants selection, treatment of study participants, assessment of efficacy, assessment of safety, statistical analysis, access to data, quality control/assurance, ethics, data handling, and publication policy are located in the Guidelines.
Clinical Trials Import Authorization
After receiving a clinical trial certificate, an investigator can apply for an import/export permit from TFDA. Full requirements are outlined in Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials.
Clinical Trial Timelines
According to the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), it takes 7-10 days for the application to be reviewed.
Clinical Trial Costs
For an application to conduct clinical trials: 3000 USD.
For a fast track clinical trial application: Double the cost of registration and analysis fee.
Full list of fees available here.
Clinical trial sponsors and host institutions are required to have appropriate and sufficient insurance before starting a clinical trial.
In-Country Manufacturing Requirements
Clinical trial products must be manufactured according to Good Manufacturing Practices (GMP).
Legal responsibilities of clinical trial investigators are outlined in Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania. Clinical trial sponsors and host institutions are required to have appropriate and sufficient insurance before starting a clinical trial. Chapter 3 of the guidelines discuss compensation that injured participants are entitled to.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
17 clinical trials approved from July 2012 to July 2014.
Product Registration Data Requirements
Registration requirements are outlined in Guidelines on Submission of Documentation for Registration of Human Medicinal Products.
An application to register a new product requires the following:
-Application forms (Quality Information Summary and Bioequivalent Information Summary-annexes 1 and 2 of the Guidelines).
-Table of contents.
-Medicinal product dossier including copies of referenced literature.
-Certificate of Pharmaceutical Product.
-5 samples of product from one batch with batch certificates of analysis. Total amount of the sample cannot be less than 200 capsules/tablets, 400ml if liquid, or 250g for creams/ointments.
-Site master file if the product is manufactured at a facility inspected and approved by the TFDA.
-Application fee for registration and GMP inspection fee if facilities have not yet been inspected and approved by the TFDA.
Product Registration Estimated Timeline
According to the guidelines for medicines registration, complete applications are evaluated within 180 working days of submission. An application can be fast-tracked and evaluated within 6 months if:
-Interest is expressed in fast-track evaluation.
-Payment of double the normal evaluation fees.
-Product is life saving, or indicated for diseases which have no registered alternative therapeutics at the time of application, or evidence is presented to show a significant advantage over existing products intended for treatment or prevention of a life threatening disease.
Product Registration Costs
Registration of locally manufactured medicinal products: 600,000 TZS
Registration of old and new foreign medicinal products: 1250 USD
Fast-track for medicinal product registration: double the cost of regular registration.
Post Registration Labeling Requirements
Outlined in Guidelines on Submission on Documentation for Registration of Human Medicinal Products Section 4.12. The guidelines are available here.
The outer label should have the following:
-Method of administration
-List of active phamaceutical ingredients used, showing the amount in each dosage unit
-List of excipients
-Indications and dosage
-Manufacturing and expiration date
-Storage and handling conditions
-Directions for use
-Manufacturer name and address
-Name and address of person/company responsible for product licensure, if different from manufacturer
-Tanzania marketing authorization number
Post-Registration Pharmacovigilance Requirements
Information on Tanzania's pharmacovigilance policy is available here.
Adverse Drug Reaction (ADR) monitoring is managed by the TFDA. All suspected ADRs are supposed to be reported regardless if the ADRs are minor or serious. The ADR reporting form requires the following information:
-Patient identifier, age/date of birth, sex, weight, medical history.
-Description of the adverse reaction including date of onset.
-Suspected drug name, dosage, route, start and stop dates, reasons for use.
-Treatment given for the reaction.
-Pre-existing medical conditions.
-Outcome of reactions.
-Name, date, signature and address of the reporting party.
There is an online ADR reporting form, but it is currently unavailable.
September 23, 2014.