Tanzania : Vaccines
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.
Clinical trial study protocol requirements are also outlined in the Guidelines for Application to Conduct Clinical Trials. 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 Trial Import Authorization
After receiving a clinical trial certificate, an investigator can apply for an import/export permit from TFDA. Full requirements are outlined in the 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)
3 clinical trials approved from July 2012 to July 2014.
Product Registration Data Requirements
Registration requirements for vaccines are outlined in Guidelines for Application for Registration of Biologicals.
-Complete documentation as stipulated in the guidelines, supported by independent expert reports.
-Certificate of Pharmaceutical Product.
-Application fee 500 USD per product to be imported or 100 USD for products produced locally.
-GMP fee 3000 USD per site for overseas facilities or 100 USD for local manufacturers.
-5 samples of product in an amount sufficient to carry quality control tests. The samples must be in the same form as the what they will be marketed in.
-Table of contents.
-Current Site Master File.
Product Registration Estimated Timeline
According to the guidelines for registering biologics, it takes 180 days for for application processing.
Product Registration Costs
Registration of locally manufactured product: 100 USD
Registration of imported product: 500 USD
GMP fee for local manufacturers: 100 USD
GMP fee for overseas facilities: 3000 USD
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.