Tanzania
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language English
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required Yes
In-country sponsor presence/representation required No
Age of minors Under 18
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: December 05, 2019
Requirements
(1) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part II (a)(4, 5, 8, 9, 10, and 11) and Part IV (c)
(2) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and Second Schedule (Declaration of Investigator)
(4) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1 and 3
Summary

Overview

As per the TMMDAct, the Tanzania Medicines and Medical Devices Authority (TMDA) (formerly known as the Tanzania Food and Drugs Authority) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Tanzania. The TMDA grants permission for clinical trials to be conducted in the country in accordance with the TMMDAct and the TFDCA-CTC. (Note: Per Additional Resource (B), TMDA is in the process of amending the TMMDAct; ClinRegs is monitoring these developments.)

Per Additional Resource (A), the TMDA is an executive agency under the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC). TMDA is responsible for regulating the safety, quality, and effectiveness of medicines, medical devices, and diagnostics.

Per the TMMDAct, the agency has a Ministerial Advisory Board, which consists of:

  • The MoHCDGEC Permanent Secretary who serves as Chairman
  • Up to 12 Minister-appointed members (currently there are five (5) members per Additional Resource (D))
  • The Director General who serves as Secretary to the board

As indicated in Additional Resource (D), TMDA was recently established following the transfer of food and cosmetic product regulatory functions to a different agency—the Tanzania Bureau of Standards. TMDA is responsible for the following regulatory processes:

  • Inspection, enforcement, testing, analysis, evaluation, and registration of medicines, medical devices, and diagnostics

  • Importation, exportation, distribution, and manufacturing of medicines, medical devices, and diagnostics

  • Clinical trials control and pharmacovigilance

As stated in Additional Resource (E), TMDA is currently reorganizing its quality policy, structure, processes, and procedures. (ClinRegs will monitor these changes and update the profile as developments are announced.)

Per the G-ResearchClearance and Additional Resource (G), the Tanzania Commission for Science and Technology (COSTECH) must review, approve, and issue permits for all research in Tanzania. The G-ResearchClearance specifies that COSTECH, through its National Research Registration Committee (NRRC), receives and reviews research proposals for their scientific merit, safety, and ethics. Upon approval, NRRC issues research permits, which registers the research in the country’s research database (Additional Resource (H)).

TMDA Contact Information

Tanzania Medicines and Medical Devices Authority
P.O. Box 1253
Mwanza Avenue, Block T, Plot No. 6
Dodoma, Tanzania

Phone: 255 22 2450512 / 2450751 / 2452108
Fax: 255 22 2450793
Email: info@tfda.go.tz
Reporting Adverse Drug Reactions Email: adr@tfda.or.tz

COSTECH Contact Information

Director General
Tanzania COSTECH
P.O. Box 4302
Ali Hassan Mwinyi Road, Kijitonyama (Sayansi) COSTECH Building
Dar es Salaam, Tanzania

Phone, general: 255 22 2771358
Phone, Director General’s Office: 255 22 277 4023
Phone, Research Registry Office: 255 22 2700749
Email, Director General: dg@costech.or.tz
Email, Research Clearance: rclearance @costech.or.tz

Per the G-ResearchClearance, all applications and attachments must be submitted to the Director General of COSTECH through an online system (Additional Resource (G)) or emailed to rclearance@costech.or.tz.

Additional Resources
(A) (Website) TMDA Profile (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
Tanzania Medicines and Medical Devices Authority
Ministry of Health, Community Development, Gender, Elderly and Children
(D) (Website) Ministerial Advisory Board (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
(E) (Public Notice) TMDA Maintains Its ISO Certification (July 17, 2019)
Tanzania Medicines and Medical Devices Authority
(F) (Website) Contact Us (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
(G) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
(H) (Website) Database and Registries – Funded Projects (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
Regulatory Authority > Scope of Assessment
Last content review/update: December 05, 2019
Requirements
(1) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(2) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-5) and First and Second Schedules
(4) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4 and 1.10), and Annex 1
(5) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1.4, 2, 3, and 5
Summary

Overview

As indicated in the TMMDAct and the TFDCA-CTC, the Tanzania Medicines and Medical Devices Authority (TMDA) is responsible for reviewing, evaluating, and approving clinical trial applications in Tanzania. The scope of the TMDA’s assessment includes all clinical trials (Phases I-IV). As delineated in the TMMDAct, the TFDCA-CTC, and the G-AppConductCT, the TMDA’s approval of a clinical trial application is dependent upon obtaining proof of national ethics committee (EC) approval. According to the G-AppConductCT, the TMDA and national EC reviews may be conducted in parallel. However, the TMDA application must include a copy of the national EC's acknowledgement of receipt for the study protocol. In addition, the TMDA's approval will only be finalized once national EC approval is obtained.

Per the G-ResearchClearance, the Tanzania Commission for Science and Technology (COSTECH) must review and approve all research in Tanzania to:

  • Ensure research conduct complies with national laws and regulations
  • Document and register research
  • Secure research results and promote its use in policy and practice
  • Safeguard the dignity, rights, safety, and well-being of research participants
  • Provide research permits

The TMDA approval must accompany the COSTECH research clearance application.

Clinical Trial Review Process

As set forth in the TFDCA, the TFDCA-CTC, and G-AppConductCT, the TMDA coordinates the clinical trial application process. Upon receipt of a clinical trial application, the TMDA initially screens the application for completeness. If complete, the TMDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Annex 1 of the G-AppConductCT). The TFDCA states that the TMDA Director General must issue a Clinical Trial Certificate to authorize the trial to be conducted. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for submission requirements.)

As for COSTECH review, the G-ResearchClearance indicates that once COSTECH receives a new application, the Secretariat screens the application for completeness; registers the applications; sends an acknowledgement to the applicant within five (5) business days; submits the application for the appropriate expert, local, and National Research Registration Committee (NRRC) review; records NRRC’s final decision; and informs the applicant of the decision.

Additional Resources
No additional resources
Regulatory Authority > Regulatory Fees
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (1.9 and 1.12) and Annex 1
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 (TFDCAFees2015) (October 23, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: First Schedule
(3) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 3
Summary

Overview

As per the G-AppConductCT and the TFDCAFees2015, applicants are responsible for paying a processing fee to submit a clinical trial application. The TFDCAFees2015 indicates that the Tanzania Medicines and Medical Devices Authority (TMDA) levies the following processing fees:

  • $3,000 USD for submitting a clinical trial application
  • Double the cost of registration and analysis fee for fast-track clinical trial applications
  • $300 USD for amendments for major changes in clinical trials
  • $300 USD for amendments for minor changes in clinical trials

See TFDCAFees2015 for a complete list of TMDA fees and charges.

Instructions for Payment of Clinical Trial Application Fee

The G-AppConductCT states that the fee must be paid to the order of TMDA directly to the bank by draft electronic transfer through the following accounts:

Foreign applicants: Account Numbers 100380013 Citibank (T) and 02J1021399100 CRDB

Local applicants: Account Number 2041100069 NMB

Applicants are responsible for all bank charges when payment is made by bank transfer. In addition, applicants must include a note with payment details, including the applicant’s name, the product(s) paid for, and the amount of fees paid.

Tanzania Commission for Science and Technology (COSTECH) Registration Fee

As delineated in the G-ResearchClearance, COSTECH charges an application fee of $50 USD to review and register a research proposal through the following bank:

National Bank of Commerce Ltd
Samora Avenue Branch
P.O. Box 9002
Dar es Salaam, Tanzania

Account Number: 012105018998
Swift Number/Code: NLCBTZTX

If the application is approved, COSTECH requires the researcher to pay a research fee of $300 USD. Permits are issued for a period of one (1) year, and can be renewed for a similar period, provided that COSTECH receives satisfactory progress reports for the previous periods. After the researcher obtains his/her research permit, he/she is required to apply for a class C residence permit from the Tanzanian Immigration Department.

Additional Resources
National Institute for Medical Research
Ethics Committee > Ethics Committee
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms and 1.13
(2) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
(3) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1 and 3
(4) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 1.2.1, 1.2.7.5, and 1.2.7.6
Summary

Overview

As indicated in the G-AppConductCT, all clinical trials require national ethics committee (EC) approval for each trial site. Per the G-TMRCC and Additional Resource (A), the national EC in Tanzania is the National Health Research Ethics Committee (NatHREC), which focuses on the ethical issues surrounding submitted research proposals, and is responsible for safeguarding the dignity, rights, safety, and well-being of research participants. Per Additional Resource (A), NatHREC supports research institutions by helping them to establish their own ECs. Institutional ECs complement NatHREC’s ethical review and monitoring functions at their institutions.

The National Institute for Medical Research (NIMR) is the governmental body responsible for EC oversight, and for the promotion and coordination of research in Tanzania. As delineated in the G-TMRCC and Additional Resources (A) and (B), the Medical Research Coordination Committee (MRCC) serves as the NIMR’s national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, in turn, delegates the registration, review, approval, and monitoring of research to the NatHREC. All clinical trial protocols to be conducted in Tanzania are reviewed by a specialized nine-member subcommittee, the Clinical Trials Sub-Committee, which meets monthly and reports to the NatHREC. Per the G-AppConductCT and Additional Resources (B), (C), and (D), proposed health research in Tanzania must also get an institutional EC approval at the host institution where the research will be based. If there is no institutional EC, the approval should be sought from NatHREC. For all health research involving foreign collaborators, the applicant must get both the institutional EC and NatHREC’s ethical approval.

Per the G-ResearchClearance and Additional Resource (F), the Tanzania Commission for Science and Technology (COSTECH) must review, approve, and issue permits for all research in Tanzania. The G-ResearchClearance specifies that COSTECH, through its National Research Registration Committee (NRRC), receives and reviews research proposals for their scientific merit, safety, and ethics. Upon approval, NRRC issues research permits, which registers the research in the country’s research database (Additional Resource (G)).

See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.

NatHREC Composition

As per the G-TMRCC and Additional Resource (E), the NatHREC is composed of 15 members—scientists and non-scientists with varying backgrounds—to promote a complete and adequate review of health research proposals commonly received by NIMR. NatHREC members are appointed by their respective institutions based on knowledge, qualifications, and experience in reviewing and evaluating the scientific, medical, and ethical aspects of research protocols. The chairperson is to be non-affiliated with the NIMR, and the Secretary is to be affiliated with the NIMR. According to Additional Resource (E), committee members must include medical scientists; biomedical scientists; social scientists; legal representatives; unaffiliated community representatives (e.g., teacher or nurse); and representatives of religious/faith-based organizations.

Institutional EC Composition

As per the G-EthicsHR, the composition and qualification requirements for the institutionally based ECs vary by host institution. A committee consisting of up to 12 members is considered to be appropriate. See sections 1.2.1 for detailed information on composition requirements, and Additional Resource (H) for links to specific institutions.

Terms of Reference, Review Procedures, and Meeting Schedule

The G-TMRCC and Additional Resource (E) state that the NatHREC must operate within written standard operating procedures (SOPs), including a process to be followed for conducting reviews. The SOPs should include information on NatHREC composition, meeting schedules, frequency of reviews, requirements for initial and ongoing evaluation of the research study, and requirements for notifying the investigator and the institution of results related to the study’s initial and ongoing evaluation.

Committee members should agree to disclose their names, occupations, and affiliations, and to sign the confidentiality and conflict of interest agreements. The appointment of committee members is valid for four (4) years. The majority of committee members must be involved in the review and approval process.

Additional Resource (E) also states that, for all active study files, the NatHREC must send the closed or completed study files to an off-site storage facility and store them for at least 15 years after the study's conclusion. For all prematurely terminated studies, the relevant records must be stored and “inactivated.” The principal investigator must keep the original versions of NatHREC’s termination memorandum and the Continuing Review Application Form in the proposal file. The proposal file should be stored and archived indefinitely.

For detailed NatHREC procedures and information on other administrative processes, see Additional Resource (E).

Additional Resources
National Institute for Medical Research
(B) (Website) Health Research Ethics (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
National Institute for Medical Research
Relevant Sections: Introduction, Vision, Mission and Functions, SOPs 01, 02, 03, 04, 08, 23, 24, and 27
(F) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
(G) (Website) Database and Registries – Funded Projects (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
(H) (Website) Tanzania – Regulation and Ethics Review of Research (Current as of December 5, 2019)
Health Research Web, Council on Health Research for Development
Ethics Committee > Scope of Review
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: Definitions and 1.2
(3) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4 and 1.10), and Annex 1
(4) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(5) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(6) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and First and Second Schedules
(7) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Summary

Overview

According to the G-TMRCC, the G-EthicsHR, and Additional Resources (A) and (B), the primary scope of information assessed by the National Health Research Ethics Committee (NatHREC) and the institutional ethics committees (ECs) relate to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in the health research. The NatHREC and the institutional ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these populations).

The NatHREC is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. Per the G-EthicsHR, institutional ECs provide a peer review from the institution’s perspective and ascertain the quality of the research outputs. The ECs must act in the interests of the potential research participants and the communities involved, evaluating the possible risks and expected benefits to participants, confirming the suitability of the investigator(s), facilities, and methods, and verifying the adequacy of confidentiality and privacy safeguards. See the G-EthicsHR and Additional Resources (A) and (B) for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the G-AppConductCT, the TMMDAct, the TFDCA-CTC, and Additional Resource (B), the Tanzania Medicines and Medical Devices Authority (TMDA) and the NatHREC must approve a clinical trial application prior to the sponsor, the contract research organization (CRO), or the principal investigator (PI) initiating the clinical trial. As per Additional Resource (A), institutional ECs are not allowed to approve research of a clinical trial nature or those trials conducted with foreign collaborators.

As indicated in Additional Resource (A), all ethical clearance certificates are valid for 12 months after which PIs are required to apply for renewal/extension. Three (3) copies of the clearance certificate will be issued (for the PI(s) and the Regional and District Medical Officers). The NatHREC will process research extension requests within a week of receiving completed application documents.

As delineated in Additional Resource (B), investigators must submit all documents for EC review and approval at least three (3) months prior to the study’s commencement. Moreover, per the G-ResearchClearance, researchers are required to obtain a research clearance and a research permit from the Tanzania Commission for Science and Technology (COSTECH). Additional Resource (B) also states that the NatHREC must review and approve any protocol amendments prior to those changes being implemented. See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed ethics submission requirements.

As indicated in Additional Resource (B), the EC is required to conduct a continuing review of the approved research study. However, if the NatHREC has not conducted a follow-up review and approval of the study by the expiration date provided in the initial TMDA approval letter, EC approval is deemed to have expired and all research activities should stop.

Additional Resources
National Institute for Medical Research
National Institute for Medical Research
Relevant Sections: Introduction, SOPs 01, 07, 09, 10, and 12
(C) (Website) Tanzania – Regulation and Ethics Review of Research (Current as of December 5, 2019)
Health Research Web, Council on Health Research for Development
Ethics Committee > Ethics Committee Fees
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
Summary

Overview

According to the G-TMRCC and Additional Resource (A), the National Health Research Ethics Committee (NatHREC) requires the sponsor, the contract research organization, or the principal investigator (PI) to pay a nonrefundable fee to submit a clinical trial research protocol for ethical review and approval.

Additional Resource (A) specifies the following fees per clinical trial research proposal:

  • International researchers – $2,000 USD
  • Tanzanian researchers – 2,000,000 Tanzanian Shillings (approximately $900 USD)
  • International students – $750 USD
  • Tanzanian students – 1,000,000 Tanzanian Shillings (approximately $450 USD)

Additional Resource (B) provides the following banking instructions for ethics application and registration fee payments:

Account Name: National Institute for Medical Research
Account Branch: CRDB Tower Branch
Account Number: 0150390615101
Swift Code: CORU TZTZ

The PI must always be listed on the bank deposit slip. The PI should also submit the original bank deposit slip (for receipt) and attach a copy of the slip to the proposal on submission.

Institutionally based ethics committees (ECs) may independently decide whether to charge fees for a protocol review.

Additional Resources
National Institute for Medical Research
(B) (Document) Bank Account Details for Ethics Payments (Date Unavailable)
National Institute for Medical Research
(C) (Website) Tanzania – Regulation and Ethics Review of Research (Current as of December 5, 2019)
Health Research Web, Council on Health Research for Development
Ethics Committee > Authorizing Body
Last content review/update: December 05, 2019
Requirements
(1) (Legislation) The National Institute for Medical Research Act, No. 23 of 1979 (MedRsrchAct) (1979)
Parliament
(2) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
(3) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 1.2.7.5 and 1.2.7.6
Summary

Overview

As mandated by the MedRsrchAct, the National Institute for Medical Research (NIMR) is the central body responsible for oversight, and for the promotion and coordination of research in Tanzania. The NIMR is a semi-autonomous organization under the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC). The G-TMRCC and Additional Resources (A) and (B) state that the NIMR’s Medical Research Coordination Committee (MRCC) serves as the national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, as the NIMR’s clearance body, delegates the registration, review, approval, and monitoring of research to the National Health Research Ethics Committee (NatHREC). The NatHREC focuses on the ethical issues surrounding submitted research proposals. All clinical trial protocols to be conducted in Tanzania are also reviewed by a specialized nine (9)-member Clinical Trials Sub-Committee, which meets monthly and reports to the NatHREC.

MRCC Composition

As delineated in the G-TMRCC, the MRCC is composed of eight (8) members including the following:

  • Director General NIMR, Chairman
  • Director, Research Coordination and Promotion, NIMR, Secretary
  • Medical Association of Tanzania Member
  • Muhimbili University College of Health Science (MUCHS) (now known as the Muhimbili University of Health and Allied Sciences (MUHAS)), Member
  • Director, Preventive Services (Ministry of Health and Social Welfare (MOHSW), Member; (However, according to Additional Resource (C), MOHSW has been renamed to the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC))
  • Head, Health Systems Research Unit (MoHCDGEC), Member
  • University of Dar es Salaam (UDSM), Member

For detailed information on the MRCC’s responsibilities, see the G-TMRCC.

NatHREC Composition

As delineated in the G-TMRCC and Additional Resource (A), the NatHREC is composed of 15 members–scientists and non-scientists with varying backgrounds—to promote a complete and adequate review of health research proposals commonly received by NIMR. NatHREC members are appointed by their respective institutions based on knowledge, qualifications, and experience in reviewing and evaluating the scientific, medical, and ethical aspects of research protocols. Committee members must include medical scientists; biomedical scientists; social scientists; a legal representative; unaffiliated community representatives (e.g., teacher or nurse); and representatives of religious/faith-based organizations. The NatHREC is represented by the following organizations:

  • NIMR
  • COSTECH
  • MUHAS
  • Christian Social Services Commission (CSSC)
  • The Muslim Council of Tanzania (BAKWATA)
  • Economic and Social Research Foundation (ESRF)
  • Tanzania Gender Networking Programme (TGNP)
  • Legal and Human Rights Centre (LHRC)
  • University of Dar es Salaam (UDSM)
  • MoHCDGEC
  • Ministry of Education (MoE)

For detailed information on the NatHREC responsibilities, see the G-TMRCC, the G-EthicsHR, and Additional Resource (A).

Auditing

As per Additional Resource (A), it is the responsibility of the NatHREC Secretariat, members, Chairperson, and administrative staff to perform his/her task according to the standard operating procedures (SOPs) and to be prepared and available to answer questions during evaluation, audit, or inspection visits by regulatory authorities. See SOP #26 of Additional Resource (A) for detailed inspection requirements.

Additional Resource (A) indicates that accrediting and monitoring ECs is a function of NatHREC. No additional information is available on registration and accreditation responsibilities by the NatHREC.

Additional Resources
National Institute for Medical Research
Relevant Sections: Vision, Mission and Functions, SOPs 01 and 26
National Institute for Medical Research
Ministry of Health, Community Development, Gender, Elderly and Children
(D) (Website) Tanzania – Regulation and Ethics Review of Research (Current as of December 5, 2019)
Health Research Web, Council on Health Research for Development
Clinical Trial Lifecycle > Submission Process
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Introduction, Module 1 (1.4 and 1.10), Modules 2-5, and Annex 1
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and Second Schedule (Declaration of Investigator)
(5) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1 and 3
(6) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
Summary

Overview

According to the G-AppConductCT, the TMMDAct, and the TFDCA-CTC, the Tanzania Medicines and Medical Devices Authority (TMDA) requires the sponsor, his/her designated contract research organization (CRO), or the investigator to obtain TMDA approval as well as ethics committee (EC) approval by the national EC, known as the National Health Research Ethics Committee (NatHREC). As per Additional Resource (A), institutional ECs are not allowed to approve research of a clinical trial nature or those trials conducted with foreign collaborators. As delineated in the G-AppConductCT and the TMMDAct, the TMDA’s approval of a clinical trial application is dependent upon obtaining proof of EC approval.

Per the G-ResearchClearance, researchers must also apply to the Tanzania Commission for Science and Technology (COSTECH), and obtain a research clearance and a research permit prior to initiating a study (see Additional Resource (B)). The TMDA approval must accompany the COSTECH research clearance application. After a foreign researcher obtains his/her research permit, he/she is also required to apply for a class C residence permit from the Tanzanian Immigration Department. See the G-ResearchClearance and Additional Resource (B) for additional details on the process for applying to COSTECH for research registration and clearance.

Delivery Address for Clinical Trial Application

The application may be delivered in person or by courier to TMDA:

Director General
Tanzania Medicines and Medical Devices Authority
P.O. Box 1253
Mwanza Avenue, Block T, Plot No. 6
Dodoma, Tanzania

Assembly and Number of Copies

As per the G-AppConductCT, applicants must submit both paper and electronic copies. The paper documents should be arranged in spring file folders, and the electronic documents should be in Word format, Bookman Old Style, font 11 and submitted on CD-ROM. The number of copies to be submitted is not specified in the G-AppConductCT. Annex 1 of the G-AppConductCT provides the Clinical Trial Application Form template. Applicants should submit their applications as per the Modules in the G-AppConductCT and the Common Technical Document (CTD) highlighted in the G-AppConductCT. The overall organization of the CTD format should not be modified.

The G-TMRCC specifies that the NatHREC within the National Institute of Medical Research (NIMR) requires all applicants to complete the Application Form for Ethics Approval (see Additional Resource (C)) to obtain ethics approval.

Clinical Trial Application Language Requirements

Per the G-AppConductCT, all applications and supporting documents must be in English. The informed consent documents must be in both Kiswahili and English.

Additional Resources
National Institute for Medical Research
(B) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
Clinical Trial Lifecycle > Submission Content
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Modules 1-5, and Annexes 1-13
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and First - Fourth Schedules
(5) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1-7, 13, and Appendix 1
(6) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
Summary

Overview

In accordance with the G-AppConductCT, the TMMDAct, and the TFDCA-CTC, the sponsor, the contract research organization (CRO), or the principal investigator (PI) must apply to the Tanzania Medicines and Medical Devices Authority (TMDA) and to the National Institute of Medical Research (NIMR)’s National Health Research Ethics Committee (NatHREC) to conduct a drug-related clinical trial. In addition to the above, per the G-ResearchClearance and Additional Resource (A), the Tanzania Commission for Science and Technology (COSTECH) must review and approve all research in Tanzania.

TMDA Requirements

As per the G-AppConductCT and the TFDCA-CTC, the following documentation must be submitted to the TMDA:

  • Comprehensive table of contents

  • Cover letter

  • Application form (See Annex 1 of the G-AppConductCT and First Schedule of the TFDCA-CTC)

  • General investigational plan

  • Capacity building plans (including plans for staff training and updates)

  • Overall summary of the protocol (See Annex 2 of the G-AppConductCT)

  • Protocol, signed and approved with data compiled as prescribed in Annex 3 of G-AppConductCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), including case report form copies or descriptions

  • Participant Information Leaflet, informed consent forms (ICFs), and any other information to be given to participants (See Annex 4 of the G-AppConductCT)

  • Declarations by the PI, co/sub investigators, and monitors (See Annexes 5-7 of the G-AppConductCT)

  • Joint declaration by sponsor and national PI in format prescribed in Annex 8

  • Investigator’s Brochure (IB), nonclinical overall summary (See Annex 10 of the G-AppConductCT), and prescribing information data sheet, if applicable

  • Certified copy of insurance of research participants

  • Ethics clearance certificate or a copy of protocol submission acknowledgement from the NatHREC or any approved medical research institute

  • Investigator(s) Curriculum Vitae(s) (CVs) (See Annex 9 of the G-AppConductCT)

  • Blank case report forms and serious adverse events reporting form to be used in the study

  • Certificate of good manufacturing practice (GMP) for manufacture of the trial medicine or other evidence of manufacturing quality, safety, and consistency

  • GMP certificate for manufacture of the placebo, if applicable

  • Investigational product (IP) labels and packages insert(s)

  • Mock-up labels for IPs

  • Evidence of accreditation/certifications of the designated laboratories or other evidence of good laboratory practice

  • Letters of access (if applicable) authorizing TMDA to access related files

  • Copies of key, peer-reviewed published articles supporting the application

  • Filled-in, quality overall summary – Chemical Entities Template (See Annex 11 of the G-AppConductCT)

  • Investigational medicinal product dossier

  • Application fees

  • Summaries of nonclinical, clinical, and quality data (See Module 2 of the G-AppConductCT)

  • Quality of the IP (See Module 3 of the G-AppConductCT)

  • Nonclinical study reports (See Module 4 of the G-AppConductCT)

  • Clinical study reports (See Module 5 of the G-AppConductCT)

As delineated in G-AppConductCT, an application must not cross reference the details or documentation between one (1) clinical trial and another. The applicant must include a statement indicating that all information in the application is complete and accurate. In the case of multi-center trials, a coordinating investigator must also sign the application form. If the trial is part of an international study, information must be provided regarding the other participating countries and the part of the trial that will be conducted locally.

In addition, per the G-AppConductCT, applicants can submit an application for amendment to a previously authorized clinical trial, using the required forms (Annexes 12 and 13). The following must be submitted to the TMDA by the sponsor or sponsor’s agent:

  • Amendment fees

  • Description and reasons for the proposed amendment

  • Original wording, revised wording, and the rationale for the change, including a complete protocol incorporating all amendments

  • Supporting data for the amendment: updated overall risk-benefit assessment, possible consequences for participants already in the trial and for assessment of trial results, and summaries of data

For details on when TMDA approval must be obtained for amendments, see G-AppConductCT.

NatHREC Requirements

As per the G-TMRCC and the NatHREC Checklist for Ethical Clearance Application Submission (see Additional Resource (D)), the NatHREC requires applicants to submit the following documentation for ethics approval:

  • Application Form for Ethics Approval (see Additional Resource (C))
  • Cover letter signed by PI or co-PI
  • Commitment letter from affiliated institution and/or local government officials
  • Four (4) copies of the protocol
  • ICFs/Assent Forms in English and Kiswahili
  • EC approval certificate from affiliating institution(s), where applicable
  • Data collection tools in English and Kiswahili
  • Elaborated recruitment procedure
  • Written information to be provided to participants in English and Kiswahili
  • Research team CVs
  • Evidence of payment of application and registration fees (Bank slip)
  • Completed Data Transfer Agreement (see Additional Resource (F)) and/or Material Transfer Agreement (see Additional Resource (G)), where applicable
  • IBs and Case Report Forms (CRFs)
  • Proof of insurance coverage
  • List of Data Safety Monitoring Board members (with at least one (1) Tanzanian)

Refer to Additional Resources (B), (C), and (D) for detailed submission requirements.

Clinical Protocol

As delineated in the G-TMRCC and Additional Resource (B) the clinical protocol should include the following elements:

  • Summary
  • Introduction and literature review
  • Statement of the problem
  • Rationale
  • Objectives
  • Methodology (including data collection instruments)
  • Study staff CVs and list of references
  • Budget and budget justification
  • Ethical considerations
  • Study limitations
  • Dissemination of research results
  • Approval from foreign and/or local ECs
  • ICFs/Assent Forms in English and Kiswahili
  • Research tools, questionnaires, and tables
  • IBs
  • Letter of Intent of Insurance
  • Any supporting documents

In addition, the G-AppConductCT requires the following protocol contents in the ICH-GCPs-Addendum format:

  • General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)

  • Background information

  • Objectives and purpose

  • Trial design

  • Selection, withdrawal, and treatment of participants

  • Assessment of efficacy

  • Assessment of safety

  • A description of the statistical methods to be used in the trial

  • Direct access to source data and documents

  • Quality control and quality assurance

  • Ethical considerations

  • Data handling and recordkeeping

  • Publication policy

COSTECH Requirements

In addition to the above, per the G-ResearchClearance and Additional Resource (A), COSTECH must review and approve all research in Tanzania. COSTECH, through its National Research Registration Committee (NRRC), receives and reviews research proposals for their scientific merit, safety, and ethics. Upon approval, NRRC issues research permits, which registers the research in the country’s research database (Additional Resource (H)). Applicants must complete the COSTECH’s application through its online submission system (see Additional Resource (A)). The application form is also available in Appendix 1 of the G-ResearchClearance. As per the G-ResearchClearance and Additional Resource (I), the form should be submitted along with the following:

  • A (scanned) copy of a receipt as proof of payment for the nonrefundable application fee (See the Regulatory Authority topic, Regulatory Fees subtopic for detailed fee information)

  • Completed CVs for all involved researchers (see Additional Resource (A))

  • A comprehensive research proposal

  • The sponsor’s cover letter

  • For foreign applicants, scientific and ethics approval from an appropriate institutional authority in the PI’s country of residence

  • Scientific and ethical clearance from NIMR and TMDA

  • Three (3) passport size photos

  • Copy of the first page of the PI’s passport (the G-ResearchClearance states this only applies to foreign applicants, while Additional Resource (I) indicates it’s required for local and foreign applicants)

  • For foreigners affiliated with local research and higher learning institutions, a recommendation letter from the local contact/collaborator (academic/research institution or host institution) for endorsement of the proposed research within the institution

See the G-ResearchClearance and Additional Resources (A) and (I) for detailed application requirements.

Additional Resources
(A) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
Relevant Sections: Application – Online Submission System, and Downloads - Template for CV and Clearance and Permits Requirements
National Institute for Medical Research
(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
National Institute for Medical Research
National Institute for Medical Research
(H) (Website) Database and Registries – Funded Projects (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
Tanzania Commission for Science and Technology
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4, 1.10, 1.13, 3.1, 3.2, and 4) and Annex 1
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and First and Second Schedules
(5) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 1-7 and Appendix 1
(6) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
Summary

Overview

Based on the G-AppConductCT, the TMMDAct, and the TFDCA-CTC, the Tanzania Medicines and Medical Devices Authority’s (TMDA) approval of a clinical trial application is dependent upon obtaining proof of ethical approval from the national ethics committee (EC), the National Health Research Ethics Committee (NatHREC). According to the G-AppConductCT, the TMDA and NatHREC reviews may be conducted in parallel. However, the TMDA application must include a copy of the NatHREC's acknowledgement of receipt for the study protocol. In addition, the TMDA's approval will only be finalized once NatHREC approval is obtained. As per the G-ResearchClearance, after receiving TMDA and NatHREC’s approvals, the researcher must submit an application for research clearance to the Tanzania Commission for Science and Technology (COSTECH) (see Additional Resource (E)).

TMDA Approval

According to the G-AppConductCT, the TMDA review process is conducted on a first-in, first out basis. TMDA will evaluate complete applications within 60 working days of receiving the application. The fast-track evaluation provides that a new clinical trial application may be fast tracked and assessed within 30 working days of its submission if the applicant has requested and paid twice the prescribed clinical trial application fee.

As set forth in the G-AppConductCT, the TFDCA, and the TFDCA-CTC, the TMDA coordinates the clinical trial application process. Upon receipt of a clinical trial application, the TMDA initially screens the application for completeness. If complete, the TMDA officer acknowledges receipt of the application by returning a signed copy of the cover sheet to the applicant (see Annex 1 of the G-AppConductCT or First Schedule of the TFDCA-CTC). Per the G-AppConductCT, the TMDA may request clarification, certificates, and/or samples through a query letter. Once a query has been raised and sent to the applicant, the evaluation process stops until the TMDA receives a written response to the query. The response should be submitted within six (6) months after the query letter was issued. In addition, TMDA reserves the right to request information or set conditions not specifically described in the G-AppConductCT to allow it to adequately assess the safety, efficacy, or quality of an investigational product (IP).

The TFDCA states that the TMDA Director General must issue a Clinical Trial Certificate to authorize the trial to be conducted. Per the G-AppConductCT, the TMDA’s clinical trial authorization will be valid up to the proposed duration of the study indicated in the application. However, the validity will not extend beyond five (5) years. If the trial needs more than five (5) years, the applicant must request an extension. If granted, TMDA will issue an updated certificate.

NatHREC Approval

Additional Resource (B) states that the NatHREC review and ethical clearance process takes six (6) to eight (8) weeks from the date of receiving a complete initial or revised submission. The expedited NatHREC review process is completed within four (4) weeks following receipt of the completed applications.

As set forth in the G-TMRCC and Additional Resources (A) and (B), the NatHREC meets once a month to evaluate application submissions. Additional Resources (A) and (B) state that the NatHREC Secretariat is responsible for receiving and processing new proposal submissions, and for ensuring that the Application Form (Form #03) (Additional Resource (C)) is properly completed and all of the protocol elements are included. Additional Resource (B) states that if the application is complete, the Secretariat forwards the proposal to the National Institute for Medical Research (NIMR) Registry section for registration (also called the Research Ethics Database in Additional Resource (A)). Additional Resource (A) indicates that NatHREC will send a letter or email to the principal investigator (PI) acknowledging receipt of the application within five (5) business days from the date of receipt. Registered proposals are returned to the Secretariat office again within one (1) day of receiving the documents from the NIMR Registry section. The proposal is then registered into NatHREC's Register and Electronic database and a step-by-step review process is begun. Applicants will receive acknowledgement of proposal acceptance for review with three (3) working days following the NatHREC's receipt of the proposal documents from the NIMR Registry section.

Per Additional Resources (A) and (B), the proposal is sent to three (3) reviewers for evaluation. Additional Resource (B) states that this occurs within four (4) working days after receiving the registered proposal from the NIMR Registry. Reviewers are required to provide comments within 14 days following proposal receipt. The reviewer(s) comments are discussed and decided upon in NatHREC's monthly meeting, and a decision is sent to the PI within three (3) working days following the committee meeting. The PI is required to respond to the committee's comments and resubmit the proposal, if necessary, within one (1) month for ordinary proposals, and within 12 weeks for clinical trial proposals. The PI may also request an extension to respond to the comments. After receiving the PI's comments, the committee will make a decision on ethical approval during the next monthly meeting. An approved proposal is recommended to the NIMR’s Medical Research Coordination Committee (MRCC) for ethical clearance. Investigators who fail to respond to NatHREC comments within three (3) months are removed from the register. Ethical clearance certificates are issued and signed by the MRCC Chairman (Director General, NIMR), and the Chief Medical Officer, Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC).

Institutional EC Approval

According to Additional Resource (A), the institutional EC review may occur prior to the proposal review by the NatHREC as the application to NatHREC requires an EC approval certificate from affiliating institution(s), where applicable. The ethical review and approval timeline varies by institution. See Additional Resource (B) for detailed requirements.

COSTECH Approval

As per the G-ResearchClearance and Additional Resource (E), all research in Tanzania must be cleared by COSTECH. Further, per the G-ResearchClearance, COSTECH, through its National Research Registration Committee (NRRC), receives and reviews research proposals for their scientific merit, safety, and ethics. Upon approval, NRRC issues research permits, which registers the research in the country’s research database. The TMDA and EC approval must accompany the COSTECH research clearance application. The G-ResearchClearance indicates that once COSTECH receives a new application, the Secretariat screens the application for completeness; registers the application; sends an acknowledgement to the applicant within five (5) business days; submits the application for the appropriate expert, local, and NRRC review; records NRRC’s final decision; and informs the applicant of the decision. The PI is then required to collect the research permit certificate from COSTECH. A proof of payment of the research permit fee ($300 USD) must be presented to the COSTECH registration desk at the time of certificate collection.

As delineated in the G-ResearchClearance, the COSTECH research permit is valid for 12 months. For research lasting more than a year, the researcher must request a renewal of the research clearance, which shall be reviewed to ensure compliance with the research proposal. See the G-ResearchClearance, for additional renewal procedures.

Additional Resources
National Institute for Medical Research
Relevant Sections: SOPs 01, 05, 07, and 09
National Institute for Medical Research
(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
(D) (Website) Tanzania – Regulation and Ethics Review of Research (Current as of December 5, 2019)
Health Research Web, Council on Health Research for Development
(E) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
Tanzania Commission for Science and Technology
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Introduction, and Module 1 (1.4, 1.9, 1.10, 1.13, 7.1, 7.3-7.7, 8.2), and Annex 1
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4), Part III, Part VI, and Second Schedule
(5) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 4
(6) (Regulation) The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 (TFDCA-ImptExpt) (July 31, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: 24
(7) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: 4.5
(8) (Guidance) Guidelines for Reporting of Safety Data in Clinical Trials (G-ReptSafetyData) (1st Edition) (May 2011)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms and 1.0
Summary

Overview

In accordance with the G-AppConductCT, the TMMDAct, and the TFDCA-CTC, a clinical trial can only commence after an applicant receives permission from the Tanzania Medicines and Medical Devices Authority (TMDA) and approval from the national ethics committee (EC), which is the National Institute of Medical Research (NIMR)’s National Health Research Ethics Committee (NatHREC). Per the G-ResearchClearance, following the TMDA and NatHREC approvals, the applicant must also apply to the Tanzania Commission for Science and Technology (COSTECH), for review, registration, and to obtain a research permit prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals.

In addition, as per the G-AppConductCT, the TMMDAct, the TFDCA-CTC, and the TFDCA-ImptExpt, the sponsor or the principal investigator (PI) is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As delineated in the G-ResearchClearance, all researchers granted COSTECH research permits that involve the collection of human data intended to be exported outside Tanzania must submit to COSTECH a signed Material Transfer Agreement (MTA) and a Data Transfer Agreement (DTA) between the Tanzanian institution and its foreign counterpart (See Additional Resources (C) and (D)). The MTA and DTA will specify the terms for collecting, storing, managing, transporting, and disposing or returning the materials and data to Tanzania.

Clinical Trial Agreement

Prior to the trial’s commencement, the G-AppConductCT specifies that the protocol must be dated and signed by the investigator, the host institution, and the sponsor, and can function as a contract. In addition, as per the G-CTInsurance, a clinical trial agreement must be signed by the Chief Executive of the host institution, the sponsor, and the PI.

EC Confirmation of Review and Approval

The G-AppConductCT, the TMMDAct, and the TFDCA-CTC, mandate that the sponsor, the contract research organization (CRO), or the PI receive written confirmation of the NatHREC’s review and approval of the protocol prior to the trial’s commencement.

As delineated in Additional Resource (F), investigators must submit all documents for EC review and approval at least three (3) months prior to the study’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Tanzania Clinical Trials Registry

As per the TFDCA-CTC, all clinical trials taking place in Tanzania must be registered with the Tanzania Clinical Trials Registry (TzCTR) (Additional Resource (H)). An applicant must submit detailed clinical trial information to the TzCTR not later than 21 days after the first participant is enrolled in the trial. See the TFDCA-CTC for complete registry submission requirements. The G-AppConductCT further stipulates that applicants have the option to register their clinical trials in the Pan African Clinical Trial Registry (PACTR) or any other publicly accessible registries accepting international clinical trial information and recognized by the World Health Organization. The registration number should be made available to TMDA.

Data and Safety Monitoring Board (DSMB)

As delineated in Additional Resource (F), the NatHREC may require a Data and Safety Monitoring Board (DSMB) for studies intended to save lives, prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly important where interim data analysis is required to ensure the safety of research participants. The primary responsibility of a DSMB is to safeguard participants by analyzing accumulating data relevant to the risks and benefits on a regular basis, especially in long-term trials. The DSMB also decides whether adverse events are serious enough to warrant termination of the study. See Additional Resource (F) for examples of the kinds of studies that may require a DSMB.

For clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country clinical trials, the DSMB should include regional representation, preferably Tanzanian, on its roster. DSMBs should submit reports to the NatHREC. Per Additional Resource (G), for clinical trials that involve a DSMB, the principal investigator must submit a list of DSMB members, including at least one (1) Tanzanian, to the NIMR.

The G-AppConductCT also specifies that a DSMB/Data Monitoring Committee (DMC) is required in situations where safety concerns may be unusually high. A DMC is recommended for any controlled trial of any size that will compare rates of mortality of major morbidity. It also indicates that a DSMB/DMC shall be considered in the following situations:

  • The study endpoint is such that a highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion

  • There are a priori reasons for a particular safety concern (e.g., if the procedure for administering the treatment is particularly invasive)

  • There is prior information suggesting the possibility of serious toxicity with the study treatment

  • The study is being performed in a potentially fragile population such as children, pregnant women or the very elderly, or other vulnerable populations, or those who are terminally ill or of diminished mental capacity

  • The study is being performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint

  • The study is large, of long duration, and multi-center

Additional details on the procedures and composition of the DSMB/DMC are provided in the G-AppConductCT.

In addition, per the G-ReptSafetyData, the sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the TMDA.

Additional Resources
(A) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
National Institute for Medical Research
National Institute for Medical Research
National Institute for Medical Research
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
National Institute for Medical Research
Relevant Sections: SOPs #7, 12 and 13
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
(H) (Website) Tanzania Clinical Trials Registry (TzCTR) (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
(I) (Website) Reporting and Monitoring of Adverse Drug Reactions (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Reporting of Safety Data in Clinical Trials (G-ReptSafetyData) (1st Edition) (May 2011)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Foreword, Responsibility, Definition of Terms, 1.0, 2.0, 3.0, and Appendix 1
(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (7.7 and 8.3) and Annex 15
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Parts I, V, and VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Pharmacovigilance) Regulations, 2018 (TFDCA-PV) (April 22, 2018)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: 47
Summary

Overview

In accordance with the G-ReptSafetyData, the G-AppConductCT, and the TFDCA-CTC, the following definitions provide a basis for a common understanding of Tanzania’s safety reporting requirements:

  • Adverse Event (AE) – Any adverse medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Suspected Unexpected Serious Adverse Reaction (SUSAR) (also referred to as Unexpected ADR) – A serious adverse reaction where the nature and severity of the event is not consistent with the medicinal product

The TFDCA-PV reaffirms that the reporting of SAEs and SUSARs occurring during clinical trials should comply with the requirements in the TFDCA-CTC.

Reporting Requirements for AEs/ADRs and SUSARs

Investigator Responsibilities

As stated in the G-ReptSafetyData and the G-AppConductCT, the investigator is responsible for reporting all AEs/ADRs, SAEs/SADRs, and SUSARs to the sponsor using the case report form (CRF)/reporting form and the SAE/SADR Reporting Form approved in the protocol, or, the CIOMS Form I. See section 3.0 of the G-ReptSafetyData for key data elements to include on the form.

The TFDCA-CTC states that the principal investigator (PI) must immediately report to the Tanzania Medicines and Medical Devices Authority (TMDA) any SAE/SADR that occurs to a participant at a trial site where he/she is responsible for the conduct of the trial. The report may be made orally or in writing, and must be followed up with a written report in 14 days. Also, the PI must report AEs that the protocol identifies as critical to safety evaluations. The reports must identify each participant by a number assigned to that participant in accordance with the protocol.

The TFDCA-CTC further states the PI or sponsor must record and report SUSARs that are fatal or life-threatening to the TMDA within seven (7) days and other SUSARS within 15 days.

Sponsor Responsibilities

The G-ReptSafetyData states that the investigator must document and report safety information to the sponsor, who, in turn, is responsible for the assessment and timely reporting of SAEs/SADRs and SUSARs to the TMDA. The sponsor must retain detailed records of safety information reported by the investigator(s), and ensure that all reports required by the TMDA are submitted on time. In addition, the sponsor must report all SAEs and SUSARs occurring from trial sites outside the country to the TMDA.

The G-ReptSafetyData requires that fatal or life-threatening SAEs/SADRs or SUSARs must be immediately reported to the TMDA by telephone, fax, or email followed by a complete report within seven (7) additional calendar days. The G-AppConductCT specifies that the immediate reporting period is within 24 hours. Further, the report should include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar products. All deaths during the study, including the post treatment follow-up period, and deaths that resulted from a process that began during the study, should be reported.

Per the G-ReptSafetyData and the G-AppConductCT, all other SAEs and SUSARs that are not fatal or life-threatening must be filed as soon as possible but no later than 14 calendar days after first knowledge by the sponsor. Please note that the TFDCA-CTC states that non-life-threatening SUSARs should be reported in 15 days.

See the G-ReptSafetyData and the TFDCA-CTC for detailed reporting requirements.

Form Completion & Delivery Requirements

As per the G-ReptSafetyData and the G-AppConductCT, all SAEs/SADRs and SUSARs must be reported on the protocol approved case report form (CRF)/reporting form, or, the CIOMS Form I, and should include trial specific details such as participants ID number and/or protocol number. The form must be submitted to the TMDA office by courier, mail, or email (as an attachment) to info@tfda.or.tz or by fax. See Annex 15 of the G-AppConductCT and Appendix 1 of the G-ReptSafetyData for the reporting forms.

Data and Safety Monitoring Board (DSMB)

As delineated in Additional Resource (D), the National Health Research Ethics Committee (NatHREC) may require that a Data and Safety Monitoring Board (DSMB) be formed to keep the committee up-to-date on the balance between risks and benefits in a clinical trial. As delineated in Additional Resource (D), the NatHREC may require a DSMB for studies intended to save lives, prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly important where interim data analysis is required to ensure the safety of research participants. The primary responsibility of a DSMB is to safeguard participants by analyzing accumulating data relevant to the risks and benefits on a regular basis, especially in long-term trials. The DSMB also decides whether adverse events are serious enough to warrant termination of the study. See Additional Resource (D) for examples of the kinds of studies that may require a DSMB.

The TFDCA-CTC states that the DSMB requirement may depend on trial design and scientific background, risk and benefit assessment, or, any other reasons determined by NatHREC. The sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the TMDA.

The G-AppConductCT also specifies that a DSMB/Data Monitoring Committee (DMC) is required in situations where safety concerns may be unusually high. A DMC is recommended for any controlled trial of any size that will compare rates of mortality of major morbidity. It also indicates that a DSMB/DMC shall be considered in the following situations:

  • The study endpoint is such that a highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion

  • There are a priori reasons for a particular safety concern (e.g., if the procedure for administering the treatment is particularly invasive)

  • There is prior information suggesting the possibility of serious toxicity with the study treatment

  • The study is being performed in a potentially fragile population such as children, pregnant women or the very elderly, or other vulnerable populations, such as those who are terminally ill or of diminished mental capacity

  • The study is being performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint

  • The study is large, of long duration, and multi-center

Additional details on the procedures and composition of the DSMB or DMC or provided in the G-AppConductCT.

Additional Resources
(A) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
National Institute for Medical Research
National Institute for Medical Research
Relevant Sections: SOP 13
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (8.4)
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV
(3) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 4 and 9
Summary

Overview

In accordance with the G-AppConductCT and the TFDCA-CTC, the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on the status of a clinical trial and for submitting a final study report.

Interim/Progress Reports

As delineated in the G-AppConductCT, the sponsor or the PI must submit progress reports to the Tanzania Medicines and Medical Devices Authority (TMDA) on a six (6)-month basis from the date of the clinical trial’s commencement. The content should be as prescribed in Additional Resource (A). The TFDCA-CTC states that progress reports should be submitted annually, or more frequently, as required by the TMDA.

According to Additional Resources (B) and (C), the investigator must submit written progress reports every six (6) months to the National Health Research Ethics Committee (NatHREC) for all ongoing approved health research activities in Tanzania.

In addition, per the G-ResearchClearance, the PI is required to submit quarterly progress reports to the Tanzania Commission for Science and Technology (COSTECH).

Final Report

The G-AppConductCT requires the sponsor or the PI to submit a closing report to the TMDA within 60 days of the trial’s completion. This report should be followed by a final study report within six (6) months after trial closure unless otherwise justified. The structure and content of the final report should comply with Additional Resource (A).

In addition, per Additional Resource (B), the PI is required to submit a final report to the NatHREC once the last participant has completed all visits and all adverse experiences have been brought to appropriate resolution. Final reports must be submitted to NatHREC on a Close-out Form (Form 08) and processed as an expedited review. The Secretariat will review the Close-out Form. The expedited reviewer will request additional information from the researcher, as needed. Written documentation acknowledging the close-out will be provided to the investigator and a copy retained in the proposal file.

The G-ResearchClearance requires the researcher to submit to COSTECH a final report, followed by a soft copy and two (2) hard copies of the research report or thesis upon completion of the research.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
National Institute for Medical Research
Relevant Sections: SOPs 12 and 18
National Institute for Medical Research
Sponsorship > Definition of Sponsor
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part I (2)
Summary

Overview

As per the G-AppConductCT and the TFDCA-CTC, a sponsor is defined as an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with the G-AppConductCT and the TFDCA-CTC, the Tanzanian government also permits a sponsor to authorize a contract research organization (CRO) to perform one (1) or more of a sponsor’s trial-related duties and functions.

Additional Resources
No additional resources
Sponsorship > Trial Authorization
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Introduction, Modules 1-5, and Annexes 1-13
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and First - Fourth Schedules
(3) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(4) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
Summary

Overview

In accordance with the G-AppConductCT, the TFDCA-CTC, and the TMMDAct, the sponsor, the contract research organization (CRO), or the principal investigator (PI) is responsible for submitting a clinical trial application to the Tanzania Medicines and Medical Devices Authority (TMDA) to obtain approval to conduct a study.

To complete the clinical trial application package, the sponsor, the CRO, or the PI must use the TMDA’s clinical trial application form provided in Annex 1 of the G-AppConductCT and the First Schedule of the TFDCA-CTC. In addition to the completed application, the sponsor, the CRO, or the PI must also provide the following:

  • Clinical protocol
  • Ethics clearance or a copy of acknowledgement of protocol submission from the National Health Research Ethics Committee (NatHREC) or any approved medical research institute
  • Informed consent form
  • Investigator’s brochure
  • Sponsor, investigator(s), and monitor(s) declarations
  • Sponsor and PI financial declaration
  • Certified copy of insurance for research participants
  • Investigational medicinal product dossier

Per the G-ResearchClearance, researchers must also apply to the Tanzania Commission for Science and Technology (COSTECH), and obtain research clearance and a research permit prior to initiating a study (see Additional Resource (A)). Further, per the G-ResearchClearance, COSTECH must review and approve all research in Tanzania. COSTECH, through its National Research Registration Committee (NRRC), receives and reviews research proposals for their scientific merit, safety, and ethics. The TMDA approval must accompany the COSTECH research clearance application. After a foreign researcher obtains his/her research permit, he/she is also required to apply for a class C residence permit from the Tanzanian Immigration Department. Upon approval, NRRC issues research permits, which registers the research in the country’s research database (Additional Resource (B)).

See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.

Additional Resources
(A) (Website) Registration (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
(B) (Website) Database and Registries – Funded Projects (Current as of December 5, 2019)
Tanzania Commission for Science and Technology
Sponsorship > Insurance
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4), and Annexes 1 and 3
(2) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Introduction and Background, 1, 2, and Appendix 1
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (4), Part IV (11-12), Part IX and First Schedule
Summary

Overview

As set forth in the G-AppConductCT, the G-CTInsurance, and the TFDCA-CTC, the sponsor or his/her designated contract research organization (CRO) is responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance and indemnify the investigator and the institution against claims arising from malpractice or negligence, and provide a copy of a valid insurance certificate from a recognized insurer in the clinical trial application submission. Additionally, per the TFDCA-CTC, the insurance policy should be obtained from an insurance company registered in Tanzania. The G-CTInsurance and the G-AppConductCT states that details and proof of insurance must be provided in the ethics review submission. Furthermore, per the TFDCA-CTC, for investigator-initiated trials, proof of current malpractice insurance that covers clinical trials must be provided to the Tanzania Medicines and Medical Devices Authority (TMDA). (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional submission requirements.)

Indemnity Agreement and Clinical Trial Insurance Policy

As per G-CTInsurance and the TFDCA-CTC, the sponsor or his/her designated CRO must sign an indemnity agreement with the host institution and the investigator(s) to cover any risks related to a research participant being injured by an investigational product, or from any procedure necessary as part of the protocol. The indemnity must be signed by the sponsor and the institution’s chief executive officer. See Appendix 1 of the G-CTInsurance for a sample agreement. Per the TFDCA-CTC, the sponsor must also indemnify the investigator against claims arising from the trial, except for claims that arise from malpractice or negligence.

The G-CTInsurance states that the insurance policy must meet the following requirements:

  • Cover the conduct of the relevant clinical trial in Tanzania
  • Contain insurance coverage for an amount sufficient to meet the indemnification requirements applicable to the EC-specified level of risk
  • Cover claims made by research participants during the trial as well as those made after the trial is completed

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Introduction and Background, 1, Appendix II
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: First Schedule (Part 6)
(3) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms and Annex 1
Summary

Overview

As specified in the G-CTInsurance, the sponsor or his/her designated contract research organization (CRO) is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. The sponsor must also ensure that participants who suffer any trial-related injuries are provided with free medical treatment for such injuries.

As per the TFDCA-CTC and the G-AppConductCT, participants may also be compensated for travel and incidental expenses incurred while participating in the trial. (See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights that must be described during the informed consent process). Per the G-AppConductCT, the clinical trial application must indicate the compensation to be received by participants, including a breakdown of costs.

Payment Procedures and Requirements

The G-CTInsurance indicates that the sponsor should provide financial compensation and medical treatment as per the recommendations of the ethics committee (EC) and ultimately the Tanzania Medicines and Medical Devices Authority (TMDA).

As per the G-CTInsurance, the amount of compensation paid should be appropriate to the nature, severity, and persistence of the injury. Compensation should be abated, or in certain circumstances excluded, in light of the following factors (which will depend on the risk level the participant can reasonably be expected to accept):

  • The seriousness of the disease being treated
  • The degree of probability that adverse reactions will occur and any warning given
  • The risks and benefits of the established treatments relative to those known or suspected of the trial medicines
Additional Resources
No additional resources
Sponsorship > Quality, Data & Records Management
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Foreword, Definition of Terms, Module 1 (1.4, 7.3, and 8.5), and Annexes 1 and 3
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV (8, 10, 11, 15, and 16)
(3) (Guidance) Guidelines for Conducting Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP) Inspection (G-GCPInspections) (1st Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Forward, Introduction, Glossary, Sections 1-7, and Appendices I, III, and IV
Summary

Overview

As stated in the G-AppConductCT and the TFDCA-CTC, the Tanzanian government complies with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) requirement that the sponsor implement and maintain quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol.

Per the ICH-GCPs-Addendum, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

  • During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results

  • Identify risks to critical trial processes and data

  • Evaluate the identified risks, against existing risk controls

  • Decide which risks to reduce and/or which risks to accept

  • Document quality management activities and communicate to those involved in or affected by these activities

  • Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant

  • In the clinical study report, describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and the investigator or any other parties involved with the clinical trial, verifying that both parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

The sponsor must also obtain the investigator(s)’ and the institution(s)’ agreement to:

  • Conduct the trial in compliance with the ICH-GCPs-Addendum, applicable regulatory requirement(s), and the protocol agreed to by the sponsor and approved by the ethics committee (EC)

  • Comply with data recording and reporting procedures

  • Permit monitoring, auditing, and inspection

  • Retain essential documents until the sponsor informs them that they are no longer needed

Also, per the TFDCA-CTC, the sponsor must ensure that all agreements made with the principal investigator (PI) and any other parties involved in a clinical trial are in writing, as part of the protocol or in a separate agreement.

As described in the G-AppConductCT, study design, statistical considerations, choice of control groups, reporting of data, and conduct of the trial should also comply with the International Council for Harmonisation’s Efficacy Guidelines (E3-E16), provided in Additional Resource (B).

Electronic Data Processing System

As per ICH-GCPs-Addendum, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per the ICH-GCPs-Addendum, the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain SOPs for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to the ICH-GCPs-Addendum for additional information.

Record Management

As set forth in the TFDCA-CTC and the ICH-GCPs-Addendum, all sponsor-specific essential documents used in the trial should be retained for at least two (2) years after formal discontinuation of the trial or the last approval of a marketing application. The TFDCA-CTC states that the investigator and the sponsor must retain all trial-related records, documents and information at the trial site for a period not less than 20 years following the trial’s completion. See the TFDCA-CTC for detailed record retention requirements. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, the ICH-GCPs-Addendum states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Audit Requirements

As part of its QA system, the G-AppConductCT and the ICH-GCPs-Addendum note that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, ICH-GCPs-Addendum, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial, ensure that the auditors are qualified by training and experience, and document their qualifications. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs, the auditor observations are documented, and data are available as needed for the Tanzania Medicines and Medical Devices Authority (TMDA).

No specific timeframe is provided for the audit process. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

The G-GCPInspections provides guidance on clinical trial inspections to ensure the trial is conducted in accordance with the study protocol, procedures, ICH-GCPs-Addendum, and regulatory requirements, and that the data is accurate and valid. Inspectees (i.e., sponsor, investigator site, and contract research organization) should follow the G-GCPInspections requirements to ensure consistent conduct of trial inspections, including uniform reporting.

Premature Study Termination/Suspension

The TFDCA-CTC and the G-AppConductCT state that if a trial is prematurely terminated or suspended, the PI or the sponsor must inform the TMDA no later than 15 days after the date of the termination, and explain the reason(s) for the termination and its impact on the proposed or ongoing clinical trials. The sponsor or PI must also inform all co-investigators of the termination, the reasons for the termination, and advise them in writing of potential health risks to research participants. For each discontinued clinical trial site, the sponsor must stop the use or importation of the investigational product (IP) from the date of the trial’s discontinuation and take all reasonable measures to ensure the recovery of all unused quantities of the IP.

According to the ICH-GCPs-Addendum, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

Multicenter Studies

As delineated in the ICH-GCPs-Addendum, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the TMDA, and given ethics committee approval

  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites

  • Investigator responsibilities are documented prior to the start of the trial

  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs

  • Communication between investigators is facilitated

The TFDCA-CTC and the G-AppConductCT also states that in the case of multicenter studies where the PI is foreign, the appointed national PI must be a resident and assume full responsibilities for all local clinical trial sites.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
(B) (Website) ICH Efficacy Guidelines (Current as of December 5, 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: E3-E16
Sponsorship > Site/Investigator Selection
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Foreword, Definition of Terms, and Module 1 (1.4 and 7)
(2) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 4
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part VIII
(4) (Guidance) Guidelines for Reporting of Safety Data in Clinical Trials (G-ReptSafetyData) (1st Edition) (May 2011)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms and 1.0
Summary

Overview

The Tanzanian government complies with the requirements delineated in the G-AppConductCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) for conducting clinical trials. As set forth in the ICH-GCPs-Addendum, the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, and for ensuring that the investigator(s) are qualified by training and experience. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. As delineated in the ICH-GCPs-Addendum and the G-AppConductCT, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s).

The G-AppConductCT delineates that the principal investigator (PI) must have the following minimum qualifications and experience:

  • University degree in medicine, pharmacy, pharmacology, toxicology, or biochemistry and related fields

  • Practical experience within the relevant professional area

  • Previous experience as a co-investigator in at least two (2) trials in the relevant professional area

  • Shall be responsible for the conduct of the clinical trial at a clinical trial site

  • Tanzanian resident

  • In good standing with a professional organization

  • For multicenter studies where the PI is not a resident of Tanzania, the appointed national PI must be a resident and should assume full responsibilities for all local clinical trial sites

  • Ensure that he or she has sufficient time to conduct and complete the trial, and those other commitments or trials do not divert essential subjects, resources, or facilities away from the trial in hand

  • The maximum number of clinical trials that a PI shall be allowed to supervise at the same time is five (5)

All investigators in a clinical trial, as well as the trial monitor, must have had formal training in Good Clinical Practices (GCP) within the last three (3) years. Evidence of attending the GCP course should be submitted.

Per the G-ResearchClearance, the Tanzania Commission for Science and Technology (COSTECH) states that if a new researcher plans to join an ongoing, permitted research project, the PI must submit to COSTECH a request for a research permit for the new member at least two (2) months prior to his/her joining the research team. The submittal should include a curriculum vitae and justification for the additional researcher. In addition, if a PI needs to be changed, the institution must notify COSTECH within one (1) month of departure of the outgoing PI. The notification should be in writing with an explanation for the change and the suitability of the new PI.

Per the G-AppConductCT, clinical trials must be carried out under conditions that ensure adequate safety for the participants. The site selected should be appropriate to the stage of development of the product and the potential risks involved. The trial site must have adequate facilities, including laboratories, equipment and sufficient medical, paramedical, and clerical staff to support the trial and to deal with all reasonable foreseeable emergencies. All laboratory assays must be validated, and principles of Good Laboratory Practice (GLP) should be observed.

Data and Safety Monitoring Board (DSMB)

As delineated in Additional Resource (C), the National Health Research Ethics Committee (NatHREC) may require a Data and Safety Monitoring Board (DSMB) for studies intended to save lives, prevent serious disease progression, or reduce the risk of a major adverse health outcome. DSMBs are particularly important where interim data analysis is required to ensure the safety of research participants. The primary responsibility of a DSMB is to safeguard participants by analyzing accumulating data relevant to the risks and benefits on a regular basis, especially in long-term trials. The DSMB also decides whether adverse events are serious enough to warrant termination of the study. See Additional Resource (C) for examples of the kinds of studies that may require a DSMB.

The TFDCA-CTC states that the DSMB requirement may depend on trial design and scientific background, risk and benefit assessment, or any other reasons determined by NatHREC.

Additional Resource (C) states that for clinical trials conducted only in Tanzania, the DSMB must include representation from Tanzania. For multi-country clinical trials, the DSMB should include regional representation, preferably Tanzanian, on its roster. DSMBs should submit reports to the NatHREC. In contrast, per Additional Resource (B), for clinical trials that require a DSMB, the PI must submit a list of DSMB members, including at least one (1) Tanzanian, to the National Institute for Medical Research (NIMR). Additionally, the TFDCA-CTC requires the following information:

  • Trial objectives and terms of reference

  • Member composition, qualifications, specific roles, and relationship to the investigators and study

  • How meetings will be organized

The G-AppConductCT also specifies that a DSMB/Data Monitoring Committee (DMC) is required in situations where safety concerns may be unusually high. A DMC is recommended for any controlled trial of any size that will compare rates of mortality of major morbidity. It also indicates that a DSMB or DMC shall be considered in the following situations:

  • The study endpoint is such that a highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion

  • There are a priori reasons for a particular safety concern (e.g., if the procedure for administering the treatment is particularly invasive)

  • There is prior information suggesting the possibility of serious toxicity with the study treatment

  • The study is being performed in a potentially fragile population such as children, pregnant women, the very elderly, other vulnerable populations, or those who are terminally ill or of diminished mental capacity

  • The study is being performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint

  • The study is large, of long duration, and multi-center

Additional details on the procedures and composition of the DSMB or DMC are provided in the G-AppConductCT and Part VIII of the TFDCA-CTC. In addition, per the G-ReptSafetyData, the sponsor must also ensure that the DSMB’s interim safety data analyses are submitted to the Tanzania Medicines and Medical Devices Authority (TMDA).

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.6
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research
National Institute for Medical Research
Relevant Sections: Introduction and SOPs 01 and 13
Informed Consent > Documentation Requirements
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4), Annex 3 (3.12), and Annex 4
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 3.1, 3.2, and 3.3
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV (8)
Summary

Overview

In all Tanzanian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the G-AppConductCT, the G-EthicsHR, and the TFDCA-CTC. As per the G-AppConductCT and the G-EthicsHR, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the national ethics committee, which is the National Health Research Ethics Committee (NatHREC), and provided to the Tanzania Medicines and Medical Devices Authority (TMDA) for approval with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The G-AppConductCT and the G-EthicsHR state that the investigator, or his/her designated representative, must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-AppConductCT and the G-EthicsHR also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Re-Consent

According to G-AppConductCT, any change in the ICF due to a protocol modification or an alteration in treatment modality, procedures, or site visits, should be approved by the NatHREC and the TMDA prior to implementing any changes. The participant and/or his/her legal representative(s) or guardian(s) should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented.

Language Requirements

As stated in the G-AppConductCT, the ICF content should be presented in Kiswahili, and all information to be given to participants, both oral and written, must be in Kiswahili. The consent form and the accompanying information must be in Kiswahili.

Documentation Copies

The G-AppConductCT states that the participant and/or the participant’s legal representative(s) or guardian(s), and the person who conducted the informed consent discussion must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant and/or his legal representative(s) or guardian(s) should also receive a copy of any updates to the signed and dated ICF, and copies of any amendments to the written information originally provided.

Additional Resources
No additional resources
Informed Consent > Required Elements
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1 (1.4), Annex 1, Annex 2, Annex 3 (3.12), and Annex 4
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Guidance) The Medical Research Coordinating Committee’s (TMRCC) Ethical Guidelines (G-TMRCC) (Date Unavailable)
Medical Research Coordinating Committee, National Institute for Medical Research
(5) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part II (3-4) and First and Second Schedules
(6) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 3.4 and 3.5
Summary

Overview

As delineated in the G-AppConductCT, the TMMDAct, the G-TMRCC, the TFDCA-CTC, the G-EthicsHR, and Additional Resource (A), prior to beginning a clinical trial, the sponsor or the principal investigator (PI) is required to obtain ethics committee (EC) approval from the National Institute for Medical Research (NIMR)’s National Health Research Ethics Committee (NatHREC) for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

The G-AppConductCT and the G-EthicsHR state that information about the research study should be clearly presented in both written and oral form.

No Coercion

As per the G-AppConductCT, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements

Based on the G-AppConductCT and the G-EthicsHR, the ICF should include the following statements or descriptions, as applicable:

  • The study purpose, procedures, and duration
  • Approximate number of participants involved in the trial
  • Experimental aspects of the study
  • The participant’s responsibilities in participating in the trial
  • Expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Disclosure of alternate procedures or treatments available to participants
  • Clinical trial treatment schedule(s) and the probability for random assignment to each treatment
  • Benefits or prorated payment to the participant or others reasonably expected from the research; if no benefit is expected, the participant should be made aware of this
  • Compensation and/or treatment available for the participant in the case of trial-related injury
  • Participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • The participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
  • Individuals to contact for further information regarding the trial, the rights of trial participants, and whom to contact in the event of trial-related injury
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • Consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
  • The participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
  • Additional costs to the participant that may result from participation in the research

See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic and the Specimens topic, Consent for Specimens subtopic for further information.

Additional Resources
National Institute for Medical Research
Relevant Sections: Introduction, SOPs 01 and 09
Informed Consent > Compensation Disclosure
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (1.4) and Annexes 1, 3, and 4
(2) (Guidance) Guidelines for Insurance and Indemnity of Clinical Trials in Tanzania (G-CTInsurance) (1st Edition) (December 2010)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Foreword, Introduction and Background, 1, 3, and 4
(3) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 7.3
(4) (Legislation) The Insurance Act, 2009 (InsuranceAct) (2009)
Tanzanian Insurance Regulatory Authority
Relevant Sections: Part A (IV)
Summary

Overview

In accordance with the G-AppConductCT, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements.)

Compensation for Participation in Research

As stated in the G-AppConductCT, the ICF should contain a statement with a description of the nature, form, and extent of compensation for study participation. The ICF should also inform the participants if they will need to pay for any expenses in order to participate in the trial.

Compensation for Injury

As per the G-AppConductCT and the G-CTInsurance, the ICF should include a statement detailing the compensation and medical treatment available in the event of any trial-related injury. The G-CTInsurance states that compensation shall be paid to a child who is injured in utero through the participation of the child's mother in a clinical trial as if the child were a participant.

In addition, the G-EthicsHR states that according to the Tanzanian InsuranceAct, insurance coverage should be provided to protect participants who may develop an illness due to participating in a trial. The Tanzanian InsuranceAct requires the following:

  • All clinical trial proposals must provide statements on how participants will be compensated in the event of adverse effects
  • The name(s) of insurance companies or brokers must be provided in the proposal
  • The terms and mode of compensation must be clearly stated in the proposal

(See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and see the Sponsorship topic, Compensation subtopic for participant compensation rights).

Additional Resources
No additional resources
Informed Consent > Participant Rights
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Annexes 4, 16, and 17
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 1.1, 3.1, 3.4, 3.5, 4, and Appendix One (1 (f))
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV (8)
Summary

Overview

As stated in the G-AppConductCT and the G-EthicsHR, the Tanzanian government complies with the ethical principles set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) and the Declaration of Helsinki which promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw

As set forth in the G-AppConductCT and the G-EthicsHR, the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As delineated in the G-AppConductCT and the G-EthicsHR, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

As per the G-AppConductCT and the G-EthicsHR, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The G-AppConductCT states that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare

As specified in the G-AppConductCT and the TFDCA-CTC, the Tanzanian government complies with the ICH-GCPs-Addendum principles that state a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(B) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
Informed Consent > Special Circumstances/Emergencies
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Annex 4 (16)
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 3.9, 3.15, 3.16, and 3.17
Summary

Overview

The G-AppConductCT and the G-EthicsHR make provisions to protect the rights of a research participant during the informed consent (IC) process when the procedure is complicated by special circumstances. Special circumstances may include medical emergencies or when a participant is mentally incapacitated.

Medical Emergencies

As per the G-AppConductCT, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If prior consent from the participant or his/her legal representative(s) or guardian(s) cannot be obtained, participant enrollment should require measures described in the protocol and/or elsewhere. Tanzania Medicines and Medical Devices Authority (TMDA) approval should also be obtained in order to protect the participant’s rights, safety, and well-being and to ensure compliance with the National Health Research Ethics Committee (NatHREC) and TMDA requirements. The participant or his/her legal representative(s) or guardian(s) should provide consent as soon as possible.

In addition, per the G-EthicsHR, in rare cases, such as an emergency, exception from IC requirements may be considered by an institutional ethics committee (EC). In this case, the institutional EC may approve a trial without requiring participant IC be obtained provided that:

  • The participant(s) are in a life-threatening situation, available treatments are unproven or unsatisfactory, and collecting valid scientific evidence is necessary to determine the safety and effectiveness of the particular intervention
  • The participant will not be able to give IC as a result of a medical condition, the intervention under investigation must be administered before consent from the legal representative(s) or guardian(s) is feasible, and, there is no reasonable way to identify prospectively the participant likely to become eligible to participate in the trial
  • Participation in the trial holds direct benefits for the participant
  • The trial could not be reasonably carried out without the waiver
  • The proposed trial activity plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator is committed to attempting to contact a legal representative(s) or guardian(s) for consent within this prescribed window rather than proceeding without consent
  • The institutional EC has reviewed and approved the IC procedures and approved the use of these procedures/documents for use with participant(s) or their legal representative(s) or guardian(s) where feasible, and, for use when providing an opportunity for a family member to object to the participant’s involvement in the trial

Please refer to section 3.17 of the G-EthicsHR for detailed requirements to be complied with during emergency situations.

Waiver of Consent

As delineated by the G-EthicsHR, although voluntary IC is always a requirement for every research proposal, this obligation can be waived by the NatHREC and an institutional EC. These general requirements may be lifted in circumstances where before the use of the investigational product (IP), both the investigator and the practicing physician, who is not otherwise participating in the trial, certify in writing the following:

  • The participant is facing a life-threatening situation necessitating the use of the IP
  • IC cannot be obtained from the participant due to an inability to communicate with or obtain legally effective consent from the participant
  • Time is insufficient to obtain consent from the legal representative(s) or guardian(s)
  • No available approved alternative or generally recognized therapy exists that provides an equal or greater likelihood of saving the participant’s life

If the investigator determines that immediate use of the IP is required to preserve the participant’s life, and he/she does not have the time to obtain an independent determination by the NatHREC or the institutional EC, the investigator must submit written documentation within five (5) working days to both an independent physician, who is not participating in the trial for review and evaluation, and to the institutional EC for review.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (7.8)
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: Definitions, 3.7, 3.10, 3.13, 3.14, 6.7, and 6.8
Summary

Overview

As per the G-AppConductCT and the G-EthicsHR, in all Tanzanian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The G-AppConductCT characterizes vulnerable populations as those who are incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes, and have an increased likelihood of being wronged or of incurring additional harm during clinical trials. For example, this includes persons who are illiterate, marginalized by their social status or behavior, or living in an authoritarian environment. Vulnerable groups include individuals in hierarchical relationships, institutionalized persons, poor people and the unemployed, some ethnic and racial minorities, homeless persons, nomads, refugees or displaced persons, people living with disabilities, people with incurable or stigmatized conditions or diseases, and people faced with physical frailty.

As per the G-EthicsHR, trials involving vulnerable persons must meet the following requirements:

  • Critical review by an ethics committee
  • Expose the participants to no or minimal risk
  • Is not contradictory to the participant’s interests
  • Must be impossible to carry out research in participants with the capacity to consent
  • Must be designed to have maximum benefit to others in this category of participants

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these vulnerable populations.

Information on the other vulnerable populations specified in the G-EthicsHR is provided below.

The Elderly

As per the G-EthicsHR, it is important to exercise special care when involving the elderly who have been in the hospital or in a residential home for a long time because they may be more dependent on others for their care. Independent but caring observer(s) for the elderly must be fully informed about the study, and must ensure that the elderly participant understands the intended research activities prior to consent.

As per the G-AppConductCT, Additional Resource (A) should be followed for clinical trials that involve:

  • New investigational products that are likely to have significant use in the elderly

  • New formulations and new combinations of established medicinal products when there is specific reason to expect that conditions common in the elderly are likely to be encountered and are not already dealt with in current labeling

  • New formulation or new combination is likely to alter the geriatric patient’s response in a way different from previous formulations

  • New uses that have significant potential applicability to the elderly

Students

The G-EthicsHR states that students involved with research studies are a vulnerable group, especially when the institution where they attend is conducting the research. Students should be permitted to withdraw from the study at any time without undue consequences. Students should also not be subject to any form of coercion, pressure, or financial inducement other than that proposed as a fee for participation.

Research Involving the Community

The G-EthicsHR specifies that in circumstances where it is unfeasible to obtain individual participant informed consent, a community may choose to have a representative who will provide consent where a study is planned to take place. The representative should be selected in a manner that conforms to the community’s traditions and culture. The authenticity of the community approval may also need to be established. An individual’s refusal to participate in a trial must be respected regardless of the community’s consent.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Informed Consent > Children/Minors
Last content review/update: December 05, 2019
Requirements
(1) (Legislation) The Law of the Child Act, 2009 (ChildAct) (2009)
Parliament
Relevant Sections: Part II (Section 4 (1))
(2) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (7.8.3) and Annex 17
(3) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: Definitions, 1.2.6, 3.8, and Appendix One (1 (k))
Summary

Overview

The ChildAct states that a person less than 18 years of age should be known as a child. As per the G-AppConductCT and the G-EthicsHR, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) and/or guardian(s). However, according to the G-EthicsHR, all pediatric participants, should be informed to the fullest extent possible about the study in language and terms that they are able to understand easily.

The G-AppConductCT delineates that data on the appropriate use of investigational products (IP) in the pediatric population should be generated unless its use in pediatric patients is clearly inappropriate. The pediatric development program should not delay completion of adult studies and availability of IPs for adults. The decision to proceed with a pediatric development program for an IP and the nature of that program should follow the requirements of Additional Resource (A).

The G-EthicsHR state that a study may only be conducted on children with a legal representative and/or guardian if the following conditions are fulfilled:

  • The trial objectives cannot be met by selecting other participants who can give informed consent personally
  • The foreseeable risks to the participants are low, or if the risk is greater than minimal, the trial presents the prospect of direct benefit to pediatric participants, or will yield generalizable knowledge about a pediatric disorder or condition
  • The negative impact on the participants’ well-being is minimal
  • The procedures should be first tested on consenting adults prior to being carried out in children
  • The trial is not prohibited by law

Assent Requirements

Per the G-EthicsHR, when the NatHREC determines that the child is capable of providing assent, the committee must verify that adequate provisions are made for soliciting the assent of the child based on his/her age, maturity, and psychological state.

The NatHREC may determine that a child’s assent is unnecessary based on the following:

  • His/her limited capacity to comprehend is so limited that he/she cannot be reasonably consulted
  • The procedure will have a direct benefit to his/her health and well-being, and is available only by participating in the trial

Even if the NatHREC determines that a child is capable of assent, the committee may still waive the assent requirement if:

  • The trial involves no more than minimal risk
  • The waiver will not adversely affect the research participant’s rights and welfare
  • The trial could not be conducted without the waiver

All pediatric participants, however, should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand. In addition, when appropriate, the pediatric participants will be provided with additional information after participating in the trial.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Module 1 (7.8.2) and Annexes 14 and 17
(2) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 3.11
Summary

Overview

The G-AppConductCT recommends that women of child-bearing potential be included at the earliest possible stages of clinical trial research so that potential sex-related differences are identified and taken into consideration when planning Phase III trials. The timing of including women of childbearing potential or pregnant women in clinical trials should comply with guidance in Additional Resource (A). Any research involving pregnant women should be individualized and based on a careful risk/benefit assessment, considering:

  • The nature and severity of the disease

  • The availability and results of previous nonclinical and clinical data

  • The availability of alternative therapy and knowledge about their risks

  • The stage of pregnancy in relation to the overall development of the fetus, especially regarding fetal brain development

  • The potential for harm to the woman, the fetus, or child

  • The long-term follow up of the pregnancy, fetus, and child, when possible

Additional considerations for including pregnant women in clinical trials are provided in the G-AppConductCT.

The G-AppConductCT identifies the following considerations for deciding whether to include breastfeeding women in clinical trials:

  • A new indication is being sought for an approved therapeutic product and there is evidence of use or anticipated use by breastfeeding women

  • After market authorization, use of a therapeutic product in breastfeeding women becomes evident

  • There is concern that the consequences of uninformed dosages for use while breastfeeding are potentially serious and/or severe

  • A therapeutic product is under review for market authorization and is expected to be used by women of reproductive age

  • The trial involves marketed medications that are commonly used by women of reproductive age

  • The risk to the infant or mother is not greater than that from established procedures routinely used during breastfeeding, is comparable to those being studied, and the purpose of the research is the development of biomedical knowledge which cannot be obtained by any other means

As per the G-EthicsHR, any research studies involving pregnant, women who may become pregnant, or fetuses, requires additional safeguards to ensure the research conforms to appropriate ethical standards and upholds societal values. The following conditions are required for the research to take place:

  • Should only be carried out if the pregnancy plays an essential role in the propose of the research
  • Appropriate studies on animals and non-pregnant women have been completed
  • The risk to the fetus is primarily due to interventions or procedures that have the greatest potential to directly benefit the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal, and the purpose of the research is to develop important biomedical knowledge which cannot be obtained by any other means
  • Any risk is the least possible for achieving the research objectives
  • Each individual providing consent is fully informed about the reasonably foreseeable impact of the research on the fetus or neonate
  • No inducements, monetary or otherwise, should be offered to terminate a pregnancy
  • Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy
  • Individuals engaged in the research will have part in determining the viability of a neonate

For all studies involving pregnant women, fetuses in utero, and fetuses ex utero, the mother and father must be both legally competent and have been fully informed of the possible impact on the fetus, and have given their informed consent to proceed. However, the father’s consent will not be required if the purpose of the study is primarily to meet the mother’s health needs, the father’s identity or whereabouts are unknown, the father is not reasonably available, or the pregnancy resulted from rape or incest.

See section 3.11 of the G-EthicsHR for additional details on pregnant women and fetuses.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Informed Consent > Prisoners
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: Definitions and 3.12
Summary

Overview

According to the G-EthicsHR, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that:

  • The research results will benefit the study population in the same category
  • The prisoners must be assured that they will not be subject to undue pressure or coercion in their decision to participate, and that their willingness or refusal to participate will not impact any decisions regarding their release or further detention
Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines of Ethics for Health Research in Tanzania (G-EthicsHR) (2nd Edition) (2009)
Tanzania National Health Research Forum, National Health Research Ethics Committee, National Institute for Medical Research
Relevant Sections: 3.9
Summary

Overview

According to the G-EthicsHR, the ethics committee must approve the participation of research participants who are incompetent, or mentally incapable of giving consent, and sufficient justification must be provided for involving this population in a study.

A research study may involve mentally impaired persons or those with learning disabilities under the following conditions:

  • The study carries no or minimal risk
  • The research may potentially benefit this category of participants and is in their best interests
  • The research may potentially benefit others in the same category
Additional Resources
No additional resources
Investigational Products > Definition of Investigational Product
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms
Summary

Overview

As delineated in the G-AppConductCT, an investigational medicinal product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes:

  • A product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form

  • When used for an unapproved indication

  • When used to gain further information about an approved use

Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: 1 and Module 1 (8.2)
(2) (Legislation) The Tanzania Medicines and Medical Devices Act, 2003 (TMMDAct) (2003) (as amended by Part VIII of the FinanceAct of 2019)
Parliament
Relevant Sections: Part IV (c)
(3) (Legislation) The Finance Act, 2019 (FinanceAct) (Adopted: June 30, 2019; Effective: July 1, 2019)
Parliament
Relevant Sections: Part VIII
(4) (Regulation) The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 (TFDCA-ImptExpt) (July 31, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: 3, 14-16-17, 24, First Schedule (Forms IV and VI), and Second Schedule
(5) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV
(6) (Regulation) The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 (TFDCAFees2015) (October 23, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: First Schedule
Summary

Overview

According to the G-AppConductCT, the TMMDAct and the TFDCA-CTC, the Tanzania Medicines and Medical Devices Authority (TMDA) is responsible for authorizing the manufacture of investigational products (IPs) in Tanzania. The TMDA will approve the manufacture of an IP after the clinical trial application has been approved.

Per the G-AppConductCT, the TMMDAct, the TFDCA-CTC, and the TFDCA-ImptExpt, the TMDA is also responsible for authorizing the import of IPs. As per the TMMDAct and the TFDCA-ImptExpt, the sponsor or the principal investigator (PI) may apply for an import license once the clinical trial application has been approved by the TMDA. The TFDCA-ImptExpt specifies that in order to be granted an import license, the applicant must:

  • Have a pharmacist registered by the Pharmacy Council who must be a Superintendent of the business

  • Have premises registered by the TMDA

  • Hold a valid business permit

Importation of raw or packaging materials is be restricted to pharmaceutical manufacturers.

The import license application should be accompanied by the clinical trial approval letter issued by the TMDA. The applicant must fill out the Application for Importation of Pharmaceutical Products provided in the First Schedule of the TFDCA-ImptExpt and pay the fee pursuant to the TFDCAFees2015. In addition, the application should be accompanied by the three (3) copies of the proforma invoice numbered and dated, and signed by the superintendent of the business. (A proforma invoice is an abridged or estimated invoice sent in advance of a shipment or delivery of goods.) The proforma invoice should include the following:

  • Name and address of the supplier

  • Name and address of the manufacturer of each product

  • Trade or proprietary name of each product

  • The international nonproprietary name (generic name) of the drug and its strength of each product

  • In the case of the product containing more than one (1) active ingredient, the name and strength of each product

  • The pharmacopoeia specification of the ingredient of each product

  • Product registration number issued by the authority for each product

  • The quantity, pack size, unit value, and total value in convertible currency

  • Batch or lot number where applicable for each product

  • Manufacturing and expiration date, where applicable, for each product

  • Mode of shipment (sea, air, or road)

  • Authorized port of entry

  • Signature and stamp of the supplier

Per Additional Resource (A), the import license application can be submitted on the TMDA Self-Service Portal. To use this portal, the applicant must submit the registration form in Additional Resource (B) to TMDA at P.O Box 77150, Dar es Salaam, Tanzania or Email: info@tfda.go.tz.

As delineated in the TFDCA-ImptExpt, the import permit is valid for six (6) months, not transferable, and issued to cover only one (1) shipment. In the case of partial shipments, three (3) shipments may be allowed based on the initial import permit. See the TFDCA-ImptExpt for detailed import application requirements.

The TFDCA-ImptExpt identifies the authorized ports of entry for pharmaceutical products imported into Tanzania. An importer must provide all necessary documents as may, from time to time, be requested by the inspector. When it is deemed necessary to collect samples or where the inspector suspects that any product may contravene any regulation or law, he/she may take samples for further investigation.

Additional Resources
(A) (Website) TMDA Self Service Portal (Current as of December 5, 2019)
Tanzania Medicines and Medical Devices Authority
(B) (Form) Customer Online Access Registration Form (Date Unavailable)
Tanzania Medicines and Medical Devices Authority
Investigational Products > IMP/IND Quality Requirements
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: 1
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV (8 and 11) and First and Second Schedules
Summary

Overview

In accordance with the G-AppConductCT and the TFDCA-CTC, the Tanzanian government follows the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), and requires the sponsor or his/her designated contract research organization (CRO) to provide investigators with an Investigator’s Brochure (IB). The G-AppConductCT and the ICH-GCPs-Addendum specify that the IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. Per the TFDCA-CTC, the sponsor should also update the IB as significant new information becomes available and maintain records of each change.

IB Content Requirements

The ICH-GCPs-Addendum require the IB to provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters

  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)

  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)

  • Summary of data and guidance for the investigator(s)

  • Bibliography

See Section 7 of the ICH-GCPs-Addendum for detailed content guidelines.

The sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable. As specified in the TFDCA-CTC, the sponsor must ensure that the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP). (See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Certificate of Analysis and Drug Manufacturing Certificate Requirements

As stated in the Manufacturing & Import subtopic, the Tanzania Medicines and Medical Devices Authority (TMDA) requires the importer to provide documentation and/or samples as requested by the customs inspector.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12, 5.13, 7.3, and 8.2
Investigational Products > Labeling & Packaging
Last content review/update: December 05, 2019
Requirements
(1) (Regulation) The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 (TFDCA-ImptExpt) (July 31, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: 26
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part VII
Summary

Overview

Investigational product (IP) labeling in Tanzania must comply with the requirements set forth in the TFDCA-ImptExpt and the TFDCA-CTC. The TFDCA-ImptExpt and the TFDCA-CTC state that for an IP to be used in a clinical trial, it must be properly labeled in English or Kiswahili (also known as Swahili) language or both, and the information printed on the labels must be indelible, engraved, or embossed on a primary and secondary container.

As set forth in the TFDCA-ImptExpt and the TFDCA-CTC, the following information must be included on the label:

  • Statement indicating that the product is for “clinical trial purpose only”
  • Name, number, or identifying mark
  • Recommended storage conditions
  • Sponsor name and address
  • Protocol code or identification
  • Trade or brand name where appropriate
  • International Non-Proprietary Name (INN, Generic name)
  • Active ingredient quantities listed in the formulation
  • Manufacture and expiration dates
  • Batch or lot number
  • Storage conditions
  • Manufacturer name and address
  • Product registration number issued by the TMDA included in the outer and inner packaging, where applicable
  • Immediate outer packaging and the enclosed and accompanying literature must be in English or Kiswahili
  • Active pharmaceutical ingredient specification (BP, USP, etc.)

According to the TFDCA-CTC, where applicable, investigational medicinal products shall be labeled in the manner that protects the blinding. Also, re-labelling of any remaining investigational medicinal product from previously manufactured batches shall be performed in accordance with established written procedures and Good Manufacturing Practice principles.

Additional Resources
No additional resources
Investigational Products > Product Management
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Definition of Terms, Module 1, Annexes 1 and 16
(2) (Regulation) The Tanzania Food, Drugs and Cosmetics (Clinical Trials Control) Regulations, 2013 (TFDCA-CTC) (March 15, 2013)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: Part IV and First and Second Schedules
(3) (Regulation) The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 (TFDCA-ImptExpt) (July 31, 2015)
Ministry of Health, Community Development, Gender, Elderly and Children
Relevant Sections: 26
Summary

Overview

In accordance with the G-AppConductCT and the TFDCA-CTC, the sponsor or his/her designated contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The G-AppConductCT also states that the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) provides more detailed information, and may be followed when preparing the IB. As per the TFDCA-CTC, the sponsor or his/her CRO should also update the IB as significant new information becomes available and maintain records of each change.

Investigational Product Supply, Storage, and Handling Requirements

As defined in the G-AppConductCT, the sponsor, his/her designated CRO, or the PI must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor, his/her designated CRO, or the principal investigator (PI) should not supply either party with the IP(s) until he/she obtains approval from the Tanzania Medicines and Medical Devices Authority (TMDA) and the National Institute for Medical Research (NIMR)’s National Health Research Ethics Committee (NatHREC).

The G-AppConductCT and the TFDCA-CTC, specify that the sponsor, his/her designated CRO, or the PI must ensure the following:

  • IP product quality and stability over the period of use
  • IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Records maintained for document shipment of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

The TFDCA-ImptExpt requires that every importer or exporter of a pharmaceutical product must, in respect to his premises, make available the following information to the TMDA: an appropriate inventory control system; inspection reports file; complaints handling procedures; and unfit medicines, controlled drugs, recall, and customer registers. Further, an importer should maintain the following documents on the premises for a period of not less than one (1) year after the expiration date of the pharmaceutical product: final invoices with corresponding import permits; copies of delivery notes; and sales invoices.

Refer to the G-AppConductCT, the TFDCA-ImptExpt, and the TFDCA-CTC, for detailed sponsor-related IP requirements.

Record Requirements

As set forth in the G-AppConductCT, which complies with the IP recordkeeping requirements delineated in the ICH-GCPs-Addendum, the sponsor must ensure maintenance of the following:

  • Records documenting IP(s) handling, storage, shipment, receipt, disposition, return, and destruction
  • A system for retrieving IPs and documenting this retrieval
  • A system to dispose of unused IP(s) and corresponding documentation
  • Sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and maintenance of records of batch samples analyses and characteristics

As per the TFDCA-CTC and the ICH-GCPs-Addendum, the sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed. All sponsor-specific essential documents used in the trial should be retained for at least two (2) years after formal discontinuation of the trial, or the last approval of a marketing application. The TFDCA-CTC states that the investigator and the sponsor must retain all trial-related records, documents and information at the trial site for a period not less than 20 years following the trial’s completion. See the TFDCA-CTC for detailed record retention requirements.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: December 05, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

In Tanzania, specimens are biological materials for medical research to be transferred between researchers/organizations for research use only (see Additional Resources (A) and (B)).

Additional Resources
National Institute for Medical Research
Relevant Sections: Article I (1.1)
(B) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
Specimens > Specimen Import & Export
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2018)
Tanzania Commission for Science and Technology
Relevant Sections: 4
Summary

Overview

As delineated in Additional Resource (A), the principal investigator (PI) is required to obtain approval for material transfers from the National Institute for Medical Research (NIMR)’s Medical Research Coordination Committee (MRCC). The National Health Research Ethics Committee (NatHREC) is responsible for the review and approval of all issues pertaining to the transfer of biological research materials on the MRCC’s behalf.

NatHREC Material Transfer Requirements

According to Additional Resource (A), for Material Transfer Agreements (MTAs), the NatHREC requires that the source provider be a Tanzanian. The provider must present an MTA that is signed and stamped by the source and recipient institutions/authorities, and that provides the specific details surrounding the materials to be transferred (see Additional Resource (B) for MTA form to be completed). The NatHREC will receive and review the MTA request and approve it within five (5) working days. Per Additional Resource (B), although the NatHREC reviews and approves the MTA request, the MRCC Chairman must ultimately authorize the form.

In addition to completing the MTA form, the PI must also complete the MRCC’s Application Form for Ethics Approval (Additional Resource (C)). The form requires the PI to state whether blood and/or any other biological materials will be involved in the study, and, if the study involves the shipment of biological samples outside Tanzania. If applicable, procedures to be used to process, store and test the biological samples (e.g., blood, genital swabs, urine, etc.) must also be described.

COSTECH Material Transfer Requirements

As delineated in the G-ResearchClearance, all researchers granted Tanzania Commission for Science and Technology (COSTECH) research permits that involve the collection of human data intended to be exported outside Tanzania must submit to COSTECH a signed MTA and a Data Transfer Agreement (DTA) between the Tanzania institution and its foreign counterpart. The MTA and DTA will specify the terms for collecting, storing, managing, transporting, and disposing or returning the materials and data to Tanzania.

Material Transfer Import Requirements

At this time no information is available on requirements to import materials to Tanzania from clinical trials being conducted outside of the country.

Additional Resources
National Institute for Medical Research
National Institute for Medical Research
Relevant Sections: Article I (1.1)
(C) (Form) Application Form for Ethics Approval (Version 1) (2010)
National Health Research Ethics Committee, Medical Research Coordinating Committee, National Institute for Medical Research, Ministry of Health, Community Development, Gender, Elderly and Children
Specimens > Consent for Specimen
Last content review/update: December 05, 2019
Requirements
(1) (Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (3rd Edition) (June 2017)
Tanzania Medicines and Medical Devices Authority
Relevant Sections: Annex 3 (3.12)
Summary

Overview

In accordance with the G-AppConductCT, prior to collecting, storing, or using a research participant’s biological specimen(s), informed consent must be obtained, including for any proposed archiving of specimens for future research.

(See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

Additional Resources
No additional resources
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