Apply In-Person:

1. To Request for Fast Track of Clinical Trials Application, the applicant has to visit the Tanzania Medical Devices Authority Link
2. Applicants should obtain the application form from the office and fill it up with all the necessary information in it.
3. Applicants must carry photocopies and originals of all the documents that areneeded for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under the “Required Documents” section of this page.
5. The Fee for this procedure has to be provided as per the authority’s request.
6. Once the fee is paid, the receipt for the payment will be provided by concerned authorities, the receipt has to be kept safe by the applicant for future use.
7. The processing time for this procedure will be mentioned by the concerned authorities.
8. Applicant will get a notification via SMS or E-mail regarding the availability of the document, right after receiving the notification, the applicant can visit the office and get their document.
9. If there is no information regarding the license that needs to be provided, the applicant can visit the office and know the status of their application.

Apply Online

1. Application form for requesting for fast track of clinical trials application is available in the following Link.
2. The applicant has to click on “Clinical Trial Registry System”.
3. If Applicants is a registered user, they have to Sign In by providing their “Trader No”, “Email Address” and “Password”.
4. If the Applicants is a new user, they have to Sign-Up by clicking on “Sign-Up(Create Account” tab available at the right corner of the Sign in tab.
5. For getting the Sign-up done, the Applicants must provide information that are asked in the following page – “Email Address”, “Trader Name”, “Country”, “Region/City”, “District”, “Postal Address”, “Physical Address”, “Contact Person”, “Mobile Number”, “TIN No”.
6. Finally, click on “Submit Account Registration Details” for completing the Sign-up process.
7. After signing up, the Applicant can Sign in, using their “Email Address”, “Trade No” and “Password”.
8. After signing in, Applicants must click on “Register for clinical trial license” for opening the needed application form for this procedure.
9. Once the application form opens, Applicants must provide all information that are requested in it.
10. Applicants must attach digital copies of all documents that are requested along with the application form before clicking on “Submit”.
11. Fee for this procedure can be paid online.
12. If all these procedures were completed properly, Applicants must click on “Submit” for uploading all there details and submitting their application form.
13. If all these procedures were followed properly by the Applicants, the license or permit will be provided within a stipulated period of time.

NOTE: Online applications can be tracked in the following Link

• Completed application form
• Brochure of the Investigator
• Clinical Study Reports
• Case Report Form (CRF)
• Subject Information and Informed Consent Form
• Clinical Study Protocol

TMDA HQ,
Location: Dar es Salaam
Address:
Nelson Mandela Rd,
Dar es Salaam, Tanzania
Contact No: +255 222450512
Contact Link
Location Link
Official Link

• Any medical authority that needs fast track of clinical trials is eligible.

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

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

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

Please attach sample completed documents that would help other people.

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

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'.

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

• Name of the Applicants
• Study Duration
• Number of Subjects
• Informed Consent
• Data Analysis
• Email Address
• Date
• Signature
• Postal Address
• Mobile Number
• Appendixes
• Concomitant medications

• Clinical Trial License or Permit is needed for undergoing any Clinical Trial like in Tanzania.
• Clinical trials are research projects carried out on human subjects and intended to assess a medicinal, surgical, or behavioural intervention.

• The main principles of an Informed consent are:
• The purpose of trial
• Methods of trial
• Study drugs and treatment regimens
• Available alternative treatments
• Potential risks and benefits
• Possible discomforts

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

• Tanzania Medical Devices Authority Link
• For more information link

More information which might help people.