Tanzania : Diagnostics
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 Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials.
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 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)
1 clinical trials approved from July 2012 to July 2014.
Product Registration Data Requirements
Registration requirements for devices are outlined in Guidance for Submission of Documentation for Registration of Medical Devices.
In Tanzania, there are four risk classes of devices: Class A (low risk, ex. tongue depressors), Class B (low-moderate risk, ex. hypodermic needles), Class C (moderate-high risk, ex. lung ventilator), Class D (high risk, ex. heart valves). Medical devices of low risk (some Class A devices) are exempted from product registration. A list of exempted medical devices is available in Annex IV of the Guidelines.
Applications to register medical devices can be made by a manufacturer, or person who wants the device to be manufactured for sale in Tanzania. If the applicant is foreign, the applicant must nominate a Local Responsible Person (LRP). Proof of nomination of a LRP should be provided by a certified copy of power of attorney, and evidence of formal agreement or any other official authorization. The LRP is responsible for:
-Monitoring the device on the market and informing TFDA if there are any problems such as manufacturing defects which can jeopardize safety.
-Facilitating communication between the applicant and TFDA.
-Managing device recalls.
-Providing technical support to users of the device.
A first time application must contain a non refundable application fee and 5 samples of the device.
Product Registration Estimated Timeline
According to the guidelines for medical device registration, processing the application will take 270 calendar days after an application has been accepted and the evaluation fees have been paid.
Product Registration Costs
Class A screening fees per dossier: 25 USD
Classes B, C, D screening fees per dossier: 50 USD
Class B evaluation fees per dossier: 500 USD
Class C evaluation fees per dossier: 750 USD
Class D evaluation fees per dossier: 1000 USD
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.