Tanzania - Application to Conduct Clinical Trials

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Procedure

Apply In-Person:

1. To apply for conducting clinical trials in Tanzania, the applicant has to approach the Tanzania Medicines & Medical Devices Authority (TMDA) contact link
2. The applicant has to get the form from the respective officer to get the trial.
3. Applicant must provide all information that is requested in the application form.
4. Applicant should make sure to carry both photocopies and originals of all documents that are needed for completing this procedure.
5. Documents that are needed for completing this procedure are mentioned under the “Required Documents” section of this page.
6. Applicant must attach photocopies of all documents (whichever is necessary) along with the application form before submitting the application form.
7. The Fee for this procedure has to be paid as per the authority’s request.
8. If all these procedures were followed properly by the applicant, the license will be provided within a stipulated period of time.
9. If there is no information regarding the license is provided within a stipulated period of time, the applicant can visit the office to know the status of their application.

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Required Documents

• Completed Application Form
• Covering Letter of the Authority
• General Investigational Plan
• Capacity Building Plans including training and updating of staff involved in the trial
• Current version of the study protocol signed and dated by sponsor and investigator
• Investigator’s Brochure or prescribing information data sheet
• Informed consent information or forms

Office Locations & Contacts

Tanzania Medicines and Medical Devices Authority,
Physical Address P.O. Box 1253, Dodoma or
P.O. Box 77150, Dar es Salaam, Tanzania
Hotline: +255 222 450 512 / 245 0 751 / 245 2108
Fax: +255 222 450 793
Email Address: [email protected]
Contact link

Eligibility

• They are the main method used by researchers to determine whether a new therapy, such as a new medication, diet, or medical gadget (such as a pacemaker), is safe and effective in humans. A clinical trial is frequently performed to determine whether a novel treatment is more efficient than the current treatment and/or has fewer negative side effects.

Fees

• The Fee for this procedure has to be paid as per the authority’s request.

Validity

• This procedure is valid for the period mentioned in it.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure will be mentioned by the concerned authorities.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.

Required Information

• Name of the Applicant
• Age
• Mobile Number
• Physical Address
• Postal Address
• Date of Birth
• Email Address

Need for the Document

• It is common practice to conduct a clinical study to ascertain whether a novel treatment is more effective than the standard of care and/or has less unfavorable side effects.

Information which might help

Enter other information that might help.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• Tanzania Medicines and Medical Devices Authority link

Others

More information which might help people.