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
Import & Export
Consent for Specimens
Malawi
QUICK FACTS
Clinical trial application languageEnglish
Parallel regulatory and ethical review permittedNo
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredYes
Age of minorsUnder 18
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
As per the PMPA, the Pharmacy, Medicines and Poisons Board (PMPB) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Malawi. The PMPB grants permission for clinical trials to be conducted in Malawi in accordance with the PMPA. See Additional Resource (A) for information related to PMPB inspections during the trial.
 
PMPB is attached to the Ministry of Health (MOH), and is granted authority by the MOH to monitor the registration and quality of drugs in Malawi. The agency is composed of a Ministry-appointed board of eight (8) members including:
  • Chief of Health Services
  • Chief Pharmacist
  • Three additional pharmacists
  • One medical practitioner
  • One veterinary surgeon
  • One nurse or midwife
Board members must be citizens of Malawi, except for the Chief of Health Services and the Chief Pharmacist who are ex officio members. The members are permitted to hold office for three (3) years. According to Additional Resource (A), the PMPB operates through nine (9) committees that oversee the following:
  • Pharmacy
  • Medicines
  • Clinical trial review
  • Inspectorate
  • Good Manufacturing Practices evaluation
  • Education
  • Poisons
  • Illegal drug handling
  • Finance and administration
The G-CTARevVacBiol and the G-CTAProcsVacBiol specify that the PMPB must appoint a Clinical Trial Review Committee (CTRC) to review clinical trial applications and make recommendations. The committee should include, but is not limited to, the following members:
  • Medical practitioners
  • Pediatrician from the National Health Sciences Research Committee (NHSRC)
  • Public health specialist from College of Medicine Research and Ethics Committee (COMREC)
  • Internal medicine specialist
  • Biostatician
  • Experts in clinical pharmacology, epidemiology, toxicology and drug safety, biotechnology, virology and microbiology, immunology, bioethics, and veterinary science

A chairperson should also be nominated by the PMPB, and the vice chairperson should be nominated by the CTRC.

Contact Information
Pharmacy, Medicines and Poisons Board
PMPB Building
PO Box 30241
Chilambula Road
Lilongwe 3, Malawi
Phone: 011 265 01 75 5165
Fax: 011 265 01 755 204
 
ADDITIONAL RESOURCES
(A) (Document) GCP Inspection Checklist (July 2007)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
(B) (Website) Health Research Web - Malawi (Current as of September 18, 2017)
Health Research Web
 
REQUIREMENTS
(1) (Legislation) Pharmacy, Medicines and Poisons Act (PMPA) (January 15, 1991)
Ministry of Health
 
Relevant Sections: Part II (Sections 3 and 4) and Part IV (Sections 42 and 44)
 
(2) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, and 3
 
(3) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, 3, 4, 5, 6, and 7
 
Regulatory Authority > Scope of Assessment
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SUMMARY
Overview
In accordance with the PMPA and Additional Resource (A), the Pharmacy, Medicines and Poisons Board (PMPB) is responsible for reviewing and approving clinical trial applications for new drugs, generic drugs, and imported drugs to be registered in Malawi.

As per the R-HlthResCoord, parallel submissions of a clinical trial application to an ethics committee (EC) and the PMPB are prohibited. According to the R-HlthResCoord and the G-HlthResConduct, the sponsor or the principal investigator must obtain a written ethical approval from either of the two (2) government-approved ECs, the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC), prior to submitting an application to the PMBP for review and approval. Per the G-HlthResConduct, COMREC, as a subsidiary of the NHSRC, reviews proposals from the faculty and students of the College of Medicine (COM) and Kamuzu College of Nursing (KCN). The NHSRC reviews proposals from all other researchers and institutions, including those from COM and KCN with national interest.
 
Clinical Trial Review Process
As delineated in the G-CTARevVacBiol and the G-CTAProcsVacBiol, the PMPB coordinates the clinical trial application process. Upon receipt of a clinical trial application, the PMPB initially screens the application for completeness. If complete, a PMPB reference number is assigned. The application is then evaluated by three (3) PMPB-appointed expert clinical trial reviewers who will provide a written report to the designated registration office, also known as the “Focal Point” office. The Focal Point office will then collate and present the expert reviews to the PMPB Clinical Trial Review Committee (CTRC). The CTRC, in turn, reviews all the available documentation, and provides a recommendation for approval or rejection. The PMPB considers the CTRC’s recommendation and issues a written approval or rejection.

(See the Ethics Committee topic, Ethics Committee subtopic for an overview of the ECs and the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)
 
ADDITIONAL RESOURCES
(A) (Website) Health Research Web - Malawi (Current as of September 18, 2017)
Health Research Web
 
REQUIREMENTS
(1) (Legislation) Pharmacy, Medicines and Poisons Act (PMPA) (January 15, 1991)
Ministry of Health
 
Relevant Sections: Part IV (Sections 42 and 44)
 
(2) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 8.0
 
(3) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Current as of September 10, 2013)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 1
 
(4) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 2 and 3
 
(5) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, 3, 4, 5, 6, 7.1, and Appendix 11
 
Regulatory Authority > Regulatory Fees
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SUMMARY
Overview
As delineated in the PMPBFees, the sponsor is responsible for paying a fee to the Pharmacy, Medicines and Poisons Board (PMPB) to submit a clinical trial application. The PMPB currently requires a non-refundable application and registration fee of $4,000 USD for registered or unregistered products in any phase. In addition, the fee to amend the application is $200 USD, and the annual renewal fee is $1,500 USD.
 
ADDITIONAL RESOURCES
(A) (Website) Health Research Web - Malawi (Current as of September 18, 2017)
Health Research Web
 
REQUIREMENTS
(1) (Guidance) Circular No. 01-FIN/2014 Fees Structure (PMPBFees) (March 10, 2014)
Pharmacy, Medicines & Poisons Board
 
Relevant Sections: 9
 
Ethics Committee > Ethics Committee
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SUMMARY
Overview
Malawi has a centralized registration process for ethics committees (ECs) and EC review. The National Commission for Science and Technology (NCST) is the governmental body responsible for EC oversight, and for the promotion and coordination of research in Malawi. As mandated by the SciTechAct, the National Research Council of Malawi (NRCM) and the Department of Science and Technology were integrated to form the NCST in 2008. The NCST is responsible to the Office of the President and Cabinet through the Department of Statutory Corporation and to the Ministry of Education, Science and Technology.

As per the R-HlthResCoord, the G-HlthResConduct, the G-NHSRC, and the G-COMREC, the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC) are the two (2) government approved ECs responsible for monitoring and evaluating human research studies. The NHSRC is authorized to review and approve proposals with a national interest, those that are multicentered, and those originating from researchers who are not faculty members or affiliates of the College of Medicine (COM) or Kamuzu College of Nursing (KCN). COMREC, as a subsidiary of NHSRC, is only permitted to review and approve studies involving or originating from COM and KCN faculty members and students.

EC Composition
As per the SciTechAct and the G-NHSRC, the NHSRC must consist of members with varying backgrounds, including the social sciences, to promote complete and adequate research proposal review. The committee should include one lay person, as well as members from the following organizations:
  • National Research Council of Malawi (1 member)
  • Ministry of Health (MOH) headquarters (2 members)
  • COMREC (2 members)
  • Community Health Sciences Unit (1 member)
  • National AIDS Commission (1 member)
  • Center for Social Research (1 member)
  • Queen Elizabeth Central Hospital (1 member)
  • Zomba Central Hospital (1 member)
  • Lilongwe Central Hospital (1 member)
  • Christian Health Association of Malawi (1 member)
  • Mzuzu University (1 member)
  • Mzuzu Central Hospital (1 member)
  • Nurses and Midwives Council of Malawi (1 member)
  • Ministry of Justice (1 member)
The chairperson and the vice chairperson are elected by the members.

The G-COMREC specifies that COMREC should be multidisciplinary, and its members must have the basic qualifications, experience, and expertise to conduct fair scientific and ethical proposal reviews. The committee must have a maximum membership of 15, and include representatives from the biomedical sciences, research methods, behavioral science, and research ethics areas. Additionally, there must also be representatives from the following:
  • NCST
  • NHSRC
  • KCN
  • Lay community
Furthermore, the committee must be diverse, have balanced gender representation, and embody community interests and concerns. Members are also required to sign a confidentiality agreement and refuse projects in which they have a conflict of interest. Members from the COM staff serving on the committee must be a minimum grade of senior lecturer, and preferably have peer reviewed publications.

Terms of Reference, Review Procedures, and Meeting Schedule
The G-NHSRC states that the MOH’s Research Unit serves as a Secretariat for the NHSRC, and is responsible for preparing materials and meeting logistics. At least half of the NHSRC must be present to conduct a review. The NHSRC members must serve on the committee for three (3) years, and are required to renew their appointments if requested by their organizations.

COMREC requires written standard operating procedures (SOPs) to be maintained, and all relevant records (e.g., SOPs, report, curriculum vitaes (CVs), meeting minutes, and correspondence) to be archived for three (3) years following the study’s completion as delineated in the G-COMREC. The majority of committee members must be involved in the review and approval process. The appointment of committee members is valid for three (3) years, and a member may be reappointed to serve another three (3) year term. The G-HlthResConduct also states that the NHSRC meets once every two (2) months and the COMREC meets every month.
 
Additional criteria for EC membership are available in the G-NHSRC and the G-COMREC.
 
ADDITIONAL RESOURCES
(A) (Website) National Commission for Science and Technology (Current as of September 18, 2017)
National Commission for Science and Technology
 
(B) (Website) NCST - National Commission for Science and Technology, Malawi (Current as of September 18, 2017)
CAAST-Net Plus, European Commission's Seventh Framework Programme
 
(C) (Website) WHO African Health Observatory - Health research (Current as of September 18, 2017)
African Health Observatory, World Health Organization
 
REQUIREMENTS
(1) (Legislation) Science and Technology Act, 2003 (No. 16 of 2003) (SciTechAct) (December 5, 2003)
Parliament
 
Relevant Sections: Part III
 
(2) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 2.0
 
(3) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 1 and 7
 
(4) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 1.0, 3.1, 3.2, 3.3, and 5.3
 
(5) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 1.0, 2.0, 3.0, 3.1, 3.2, 3.3, 4.0, 5.7, and 8.0
 
Ethics Committee > Scope of Review
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SUMMARY
Overview
According to the G-NHSRC and the G-COMREC, the primary scope of information assessed by the two (2) government-approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC), relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

Per the G-NHSRC, the G-COMREC, and the G-HlthResConduct, the NHSRC and the COMREC must 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 NHSRC and the COMREC are also responsible for ensuring an independent, timely, and competent review of all ethical and scientific aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, methods and scientific design of the study; assessing the participant recruitment process; and verifying the adequacy of confidentiality and privacy safeguards.

Role in Clinical Trial Approval Process
As per the R-HlthResCoord, the G-NHSRC, the G-COMREC, and the G-CTARevVacBiol, the Pharmacy Medicines and Poisons Board (PMPB) and the EC must approve a clinical trial application prior to the sponsor or the principal investigator (PI) initiating the clinical trial. The sponsor or the PI must obtain a written approval from either of the two (2) government-approved ECs, the NHSRC or COMREC, prior to submitting an application to the PMPB for review and approval. The R-HlthResCoord, the G-NHSRC, and the G-COMREC also state that the EC must review and approve any protocol amendments prior to those changes being implemented.
 
Moreover, for all studies originating outside Malawi, the sponsor or the PI is required to obtain approval from an EC based in his/her country prior to submitting an application to the NHSRC or the COMREC for ethical review and approval.

As delineated in the R-HlthResCoord, the NHSRC is designated and mandated to review and approve multicenter clinical trials, including those originating outside Malawi. The NHSRC will conduct a full initial review of the same protocols for a multicenter study submitted by different investigators provided that such protocols are submitted simultaneously. Protocols for the same multicenter trial to be implemented at different institutions may also be merged into one (1) protocol that the NHSRC will treat as a joint submission for review. In addition, as stated in the G-HlthResConduct, the PI is required to submit application materials to both committees at least three (3) weeks before the date of the review meeting. (See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process requirements.)

The G-NHSRC and the G-COMREC specify that the approval of a new application is valid for one (1) year. All approved studies running for more than one (1) year are subject to continuing annual review by the approving EC. The application for continuing EC review must be made three (3) months before the expiration of the previous approval.
 
Per Additional Resource (A), throughout the trial, COMREC monitors the study via annual progress reports, data safety reports, and site inspections to ensure compliance with the protocol, the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), human subjects protection guidelines (e.g., CIOMS’ International Ethical Guidelines for Biomedical Research Involving Human Subjects), the good clinical laboratory practices guidelines, and applicable regulatory requirements.
 
 
ADDITIONAL RESOURCES
(A) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 20
 
(B) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Council for International Organizations of Medical Sciences (CIOMS)
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 1.0, 2.0, 3.1, 5.1.4, 5.1.5, 6.2, and 9.2
 
(2) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 1.0, 3.2, 3.3.4, 5.1, 5.5, and 5.4
 
(3) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 7 and 9
 
(4) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.0, 7.2.5, 7.2.12, 7.2.13, 8.1, 8.2, 8.3, and 8.6
 
(5) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Current as of September 5, 2013)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, 3, 4, 5, and 6
 
Ethics Committee > Ethics Committee Fees
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SUMMARY
Overview
According to the G-NHSRC, the G-COMREC, the R-HlthResCoord, and the G-HlthResConduct, the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC) require the sponsor or the principal investigator (PI) to pay a nonrefundable fee to submit a protocol for ethical review and approval.

NHSRC Fees
The G-NHSRC, the R-HlthResCoord, and the G-HlthResConduct specify that non-Malawian researchers must pay $150 USD and Malawian researchers must pay 500 Malawian Kwacha. Following the protocol’s approval, the sponsor or the PI must also pay the Ministry of Health (MOH) a fee of 10% of the total budget indicated in the proposal to cover NHSRC institutional capacity strengthening and administrative operating expenses.
 
COMREC Fees
As per the G-COMREC and Additional Resource (A), COMREC charges the sponsor or the PI a fee of $100 USD or 500 Malawian Kwacha for each new protocol submission and for the resubmission of a protocol to be reviewed for the fourth time. Additional Resource (B), on the other hand, states that the fee is $150.COMREC permits eligible investigators to apply to management for exemption from paying this processing fee. The R-HlthResCoord and Additional Resource (A) state that the COMREC is also mandated to charge the MOH capacity building and administrative overhead fee of 10% of the total budget for each research protocol that it reviews.
 
 
ADDITIONAL RESOURCES
(A) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 11, 12, 13, and 14
 
College of Medicine Research and Ethics Committee
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 8.0
 
(2) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 3.3.10
 
(3) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.2.10, 7.2.11, and 7.2.12
 
(4) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 8
 
Ethics Committee > Authorizing Body
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SUMMARY
Overview
As mandated by the Science and Technology Act No. 16 of 2003, the National Commission for Science and Technology (NCST) is the central statutory body responsible for coordinating and regulating all research, science, and technology related activities in Malawi. In 2008, the National Research Council of Malawi (NRCM) and the Department of Science and Technology were integrated to form the NCST, which is responsible to the Office of the President and Cabinet through the Department of Statutory Corporation and to the Ministry of Education, Science and Technology.

The R-HlthResCoord states that the NCST provides oversight to the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC). The NCST’s core responsibilities in this capacity include:
  • Participating as an ex-officio member on NHSRC and COMREC by having a voting representative from the NCST sit on both committees
  • Reviewing and approving the ethics committees’ (ECs’) guidelines and standard operating procedures
  • Monitoring the ECs’ performance and adherence to relevant national policies, laws, regulations, and guidelines
NCST Composition
As delineated in Additional Resources (B) and (C), the NCST is governed by a board of 15 commissioners consisting of the following:
  • One (1) Chairman
  • The Secretariat
  • Nine (9) Ministry of Health (MOH) appointed members with at least six (6) members selected from industry, academic, research and development institutions, as well as one (1) community representative, and one (1) gender expert
  • Four (4) to five (5) permanent secretaries who are ex-officio members, and represent ministries relevant to science and technology
The Secretariat serves as the NCST’s chief executive, and is responsible for program implementation. The NCST’s mandates and functions are implemented by directorates covering the following areas:
  • Research and Technology Transfer
  • Planning, Monitoring, and Evaluation Services
  • Documentation and Information Services
  • Finance and Administration
For detailed information on the NCST composition and responsibilities, see Additional Resources (B) and (C).

No information is available on registration, auditing, and accreditation responsibilities by the NCST.
 
ADDITIONAL RESOURCES
(A) (Website) National Commission for Science and Technology (Current as of September 18, 2017)
National Commission for Science and Technology
 
(B) (Website) National Commission for Science and Technology - About NCST (Current as of September 18, 2017)
National Commission for Science and Technology
 
(C) (Website) NCST - National Commission for Science and Technology, Malawi (Current as of September 18, 2017)
CAAST-Net Plus, European Commission's Seventh Framework Programme
 
REQUIREMENTS
(1) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 2.0 and 2.2
 
Clinical Trial Lifecycle > Submission Process
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SUMMARY
Overview
According to the G-CTARevVacBiol and the R-HlthResCoord, the Pharmacy, Medicines and Poisons Board (PMPB) requires the sponsor or the principal investigator (PI) to obtain PMPB approval and ethics committee (EC) approval of a clinical trial application.

As stated in the R-HlthResCoord, the sponsor or the PI must obtain written ethics approval from either of the two (2) government approved ECs, the National Health Sciences Research Committee (NHSRC), or the College of Medicine Research and Ethics Committee (COMREC) prior to submitting an application to the PMPB for review and approval. (Please refer to the Ethics Committee topic, Ethics Committee subtopic for additional information on the EC process).

Moreover, as specified in the G-CTARevVacBiol and the R-HlthResCoord, for all studies originating outside Malawi, the sponsor or the PI is required to obtain approval from an EC based in his/her country prior to submitting an application to the NHSRC or the COMREC for ethics review and approval. Additional Resource (D) also indicates that the COMREC prefers the investigator apply for ethics approval first from an external/overseas EC.
 
In the case of multicenter studies, per the R-HlthResCoord and Additional Resource (D), the NHSRC will conduct a full initial review of the same protocols for a multicenter study submitted by different investigators provided that the protocols are submitted simultaneously. The NHSRC will also treat a protocol containing several merged protocols for the same multicenter trial to be implemented at different institutions as a joint submission for review.

The G-NHSRC and the G-COMREC delineate the core documentation requirements required to submit a protocol to the NHSRC and the COMREC. Checklists (see Additional Resources (C) and (E)) must be completed and submitted to the NHSRC or COMREC along with the protocols. Also refer to Additional Resource (D) for detailed COMREC submission requirements.
 
Delivery Address for Research Protocol
Per the G-HlthResConduct, research protocols and relevant materials should be submitted to the NHSRC and COMREC should be sent to:
 
The Chairperson
National Health Sciences Research Committee
Ministry of Health
P.O. Box 30377
Lilongwe 3, Malawi
 
Tel: +265 1 789 400/414
Fax: +235 1 789 527/536
Email: doccentre@malawi.net

Delivery Address for Clinical Trial Application
Application submission address information is not available from the PMPB website because the site is not currently active. However, Additional Resource (A) states that clinical trial applications and correspondence should be mailed to:

Pharmacy, Medicines and Poisons Board
PMPB Building
PO Box 30241
Chilambula Road
Lilongwe 3, Malawi

Assembly and Number of Copies
As per the G-CTARevVacBiol and Additional Resource (B), applicants must submit three(3) copies of the clinical trial application form to the PMPB.

Clinical Trial Application Language Requirements
The PMPA requires all application forms to be completed in English.
 
ADDITIONAL RESOURCES
(A) (Website) Health Research Web - Malawi (Current as of September 18, 2017)
Health Research Web
 
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
College of Medicine Research and Ethics Committee
 
(D) (Website) COMREC FAQs (Current as of June 15, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 1-10
 
(E) (Checklist) NHSRC Checklist (Date Unavailable)
National Health Sciences Research Committee
 
National Health Sciences Research Committee
 
REQUIREMENTS
(1) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1
 
(2) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.0, 7.2.5, 7.2.12, 7.2.13, and 8.0
 
(3) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.1
 
(4) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.0
 
(5) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 8
 
(6) (Legislation) Pharmacy, Medicines and Poisons Act (PMPA) (January 15, 1991)
Ministry of Health
 
Relevant Sections: Pharmacy, Medicines and Poisons Regulations (Part II (3))
 
Clinical Trial Lifecycle > Submission Content
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SUMMARY
Overview
Requirements related to content of Clinical Trial Authorization are determined by the specific ethics committee (EC) from whom EC approval must be obtained and the specific requirements of the regulatory authority.

In accordance with the G-CTARevVacBiol, the R-HlthResCoord, and Additional Resource (D), the sponsor or the principal investigator (PI) must apply to the Pharmacy, Medicines and Poisons Board (PMPB) and to either of the two (2) government approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC), to conduct a drug-related clinical trial. The PMPB’s review and approval of a clinical trial application is dependent upon obtaining written proof of the EC’s approval. For international application submissions, foreign sponsors or PIs are required to obtain approval from an EC in their own country prior to submitting an application to the NHSRC. Furthermore, according to the G-NHSRC, foreign researchers must be affiliated to a local institution and provide a supporting letter from the institution as evidence. Additionally they must have a local collaborator.

PMPB Requirements
As per the G-CTAProcsVacBiol and the G-CTARevVacBiol, the following documentation must be submitted to the PMPB:
  • Cover letter
  • Clinical Trial Application (Form CT 8) (See Additional Resource (A))
  • Protocol
  • Investigator’s Brochure (IB)
  • Proof of payment and financial declaration
  • Report summaries of prior clinical trials with this medicine
  • Participant Information Leaflet and Informed Consent Form (ICF)
  • Certificate of Good Manufacturing Practice (GMP) for the manufacture of the trial medicine and the placebo, if applicable
  • Batch release certificate
  • Package insert(s) for other trial medicines
  • Evidence of accreditation of the designated laboratories
  • Insurance certificate specific for this trial (Please refer to Sponsorship topic, Insurance subtopic for additional information about insurance requirements.)
  • Authorization of the clinical trial from the country of origin, if applicable
  • Signed and completed declarations by investigators
  • Documented EC approval
  • Investigator(s) Curriculum Vitae(s) (CVs)
  • Full, legible copies of key, peer-reviewed published articles supporting the application
See G-CTAProcsVacBiol and the G-CTARevVacBiol for detailed PMPB application submission requirements.

NHSRC Requirements
  • Cover letter from the PI
  • 20 copies of the proposal (see Additional Resource (E) for proposal details
  • Data collection instruments in both English and Chichewa (or other appropriate language)
  • Informed consent in both English and Chichewa (or other appropriate language)
  • Letter of approval from foreign EC (for all students studying in foreign universities)
  • Application fee (U$ 150)
  • CVs for all the investigators
  • Approval certificate from the PMPB where the research involves products such as new pharmaceutical products
If any of the above items are not included in the submission to the NHSRC, an explanation must be provided.  Please note that while the NHSRC checklist (Additional Resource (E)) indicates that the PMPB approval must be provided, the R-HlthResCoord indicates that EC approval must be obtained prior to submitting clinical trial application to the PMPB.

COMREC Requirements
  • Cover letter from the PI
  • Signed and dated COMREC application form
  • Protocol
  • Data collection tools (e.g., participant case report forms, questionnaires, etc.)
  • Investigator(s) CV(s)
  • Material to be used (including advertisements) to recruit potential research participants
  • ICF including both English and the local language(s)
  • Itemized budget
  • IB or package insert(s)
  • Letter of support from department head
See the G-NHSRC, the G-COMREC, and Additional Resources (D), (E), and (F) for detailed EC application requirements.

Clinical Protocol
As delineated in the G-CTAProcsVacBiol and the G-HlthResConduct the clinical protocol should comply with the format provided in the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs). The following elements should be included:
  • Cover page
  • Protocol summary/abstract
  • Background and justification
  • Sponsor or authorized representative name and contact information
  • Investigator(s) CV(s) and contact information
  • Investigational Product description (See Investigational Products topic for detailed coverage of this subject)
  • Form, dosage, route, method, and frequency of administration and treatment period
  • Summary of potential risks and known benefits to research participants
  • Hypothesis
  • Trial objectives and purpose
  • Trial design, random selection method, and blinding level
  • Work plan/Gantt chart
  • Participant selection/withdrawal
  • Participant treatment
  • Safety and efficacy assessments
  • Literature review
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Statistics and methods to track trial data
  • Sponsor specifications for direct access to source data/documents
  • Quality control/quality assurance procedures and practices
  • Ethical considerations
  • Data management and recordkeeping
  • Dissemination of findings
  • Financing and insurance details
  • Publication policy
  • Consent form
For more detailed protocol requirements, refer to the ICH-GCPs and the G-HlthResConduct.
 
Also, the G-NHSRC and the G-COMREC delineate the core documentation requirements required to submit a protocol to the NHSRC and the COMREC. Checklists (see Additional Resources (E) and (F)) must be completed and submitted to the NHSRC or COMREC along with the protocols. Also refer to Additional Resource (D) for detailed COMREC submission requirements.
 
ADDITIONAL RESOURCES
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
National Health Sciences Research Committee
 
(C) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: Chapter 6
 
(D) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 1-10
 
(E) (Checklist) NHSRC Checklist (Date Unavailable)
National Health Sciences Research Committee
 
College of Medicine Research and Ethics Committee
 
National Health Sciences Research Committee
 
REQUIREMENTS
(1) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, 3.2, and Screening Form
 
(2) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.0, 7.2.5, 7.2.12, 7.2.13, and 8.0
 
(3) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: Checklist of Required Documents
 
(4) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.1
 
(5) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.0
 
(6) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 5
 
Clinical Trial Lifecycle > Timeline of Review
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
The timeline for review involves two (2) distinct approval cycles, one (1) from the appropriate ethics committee (EC), and one from the regulatory authority.

As stated in the R-HlthResCoord, one (1) of the two (2) government approved ECs, the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC), must review and approve a clinical trial application prior to the Pharmacy, Medicines and Poisons Board (PMPB) initiating its review and approval process. Parallel submissions of a clinical trial application to an EC and the PMPB are prohibited.

Moreover, as specified in the G-CTARevVacBiol and the R-HlthResCoord, for all studies originating outside Malawi, the sponsor or the principal investigator (PI) is required to obtain approval from an EC based in his/her country prior to submitting an application to the NHSRC or the COMREC for ethics review and approval. Additional Resource (A) also indicates that the COMREC prefers the investigator apply for ethics approval first from an external/overseas EC. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

PMPB Approval
According to the G-CTARevVacBiol, the PMPB review process takes approximately six (6) weeks.

As per the G-CTARevVacBiol and the G-CTAProcsVacBiol, once the dossier is submitted to the PMPB, the evaluation process is divided into two (2) phases. The first phase is administrative or quantitative, and requires the PMPB’s Registration Office, known as the “Focal Point” Office, to screen the applications for completeness. The second phase is technical or qualitative, and requires three (3) PMPB appointed expert clinical trial reviewers to conduct a scientific assessment of the applications. The reviewers prepare a written report within 14 days and submit it to the Focal Point office for collation and presentation to the PMPB Clinical Trial Review Committee (CTRC). The CTRC then reviews the report and all of the available documentation to provide a recommendation for approval or rejection. The CTRC’s recommendation is then forwarded to the PMPB, which is responsible for making the final decision regarding the trial.

Ethics Committee Approval
NHSRC Approval
The G-NHSRC and the R-HlthResCoord do not specify an official timeline for the NHSRC ethical review and approval process. However, as per the G-NHSRC and the G-HlthResConduct, the NHSRC meets for business once every two (2) months to evaluate application submissions, and the members receive the research proposals two (2) weeks prior to the scheduled meetings to review the submissions. The Research Unit of the Ministry of Health (MOH), which serves as the NHSRC’s secretariat, performs an initial screening of all applications for completeness, and makes a preliminary determination of the type of review to be conducted. The chairperson or the vice-chairperson makes the final determination as to the type of review, which may include:
  • All high risk studies
  • Studies involving vulnerable populations (including pregnant women, prisoners, mentally incompetent patients, etc.)
  • Any clinical interventional study that randomly assigns research participants to alternative experimental or placebo groups
  • Studies involving sensitive information connected to personal identifiers
  • Studies previously reviewed but require major issues to be addressed
COMREC Approval
As per the G-COMREC and the G-HlthResConduct, the COMREC review and approval process generally takes one (1) month. A written decision is provided to the applicant within two (2) weeks of the meeting at which the decision was made.
 
In addition, as stated in the G-HlthResConduct, for both COMREC and NHSRC, the PI is required to submit application materials at least three (3) weeks before the date of the review meeting.
 
ADDITIONAL RESOURCES
(A) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 6
 
REQUIREMENTS
(1) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.0, 7.2.5, 7.2.12, 7.2.13, and 8.0
 
(2) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Current as of September 5, 2013)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, and 3
 
(3) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 2, 3, 4, 5, and 6
 
(4) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 3.3, 4.1, 4.4, 5.1, and 5.2
 
(5) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 7
 
(6) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.0, 5.1, and 5.9
 
Clinical Trial Lifecycle > Trial Initiation
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with the G-CTARevVacBiol and the R-HlthResCoord, a clinical trial can only commence after an applicant receives permission from the Pharmacy, Medicines and Poisons Board (PMPB) and approval from either of the two (2) government approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC). Moreover, as specified in the R-HlthResCoord, for all studies originating outside Malawi, the sponsor or the principal investigator (PI) is required to obtain approval from an EC based in his/her country prior to submitting an application to the NHSRC or the COMREC for ethical review and approval. No waiting period is required following the applicant’s receipt of these approvals.

In addition, as per the PMPA and the D-ImprtRelIMPs, the sponsor is required to obtain an import license for the shipment of the investigational product (IP) to be used in the trial (See Additional Resource (A) for the World Health Organization guidance and template used by Malawi). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information.

As stated in the G-CTAProcsVacBiol, all investigators must also possess appropriate qualifications, training, and experience. The trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs). All clinical trials must also be conducted in a laboratory that can provide evidence of accreditation with a recognized control authority to conduct the specified test. In the absence of an accreditation authority, proof of Good Laboratory Practice compliance and validation of assay methods should be provided.

The G-CTAProcsVacBiol requires the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins. In addition, the investigators and the sponsor or his/her contract research organization must sign an agreement specific to the clinical trial.
 
Clinical Trial Agreement
The G-CTAProcsVacBiol requires the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins. In addition, the investigators and the sponsor or his/her contract research organization must sign an agreement specific to the clinical trial.

EC Confirmation of Review and Approval
The G-CTAProcsVacBiol, the G-CTARevVacBiol, and the R-HlthResCoord mandate that the sponsor or the PI obtain written confirmation of EC review and approval from the NHSRC or the COMREC prior to the trial’s commencement. The sponsor should also obtain from the investigator documentation and dates relating to any EC re-evaluations, re-approvals, withdrawals, or suspensions of approval. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).
 
Clinical Trials Registry
No clinical trials registry exists at this time and there is no stated requirement to register in an international registry.
 
Data Safety Monitoring Board
As per the G-CTAProcsVacBiol, a Data Safety Monitoring Board (DSMB) or a similar body must be established and empowered to regularly assess the trial and to recommend a pause or termination of the trial for safety reasons. In addition, per Additional Resource (C), COMREC requires DSMBs to be instituted for all clinical studies involving humans where:
  • The investigation of a research question has direct implications for clinical care or public health, including all Phase III trials
  • The population is classified as highly vulnerable
  • The trials involve high risk intervention for large multicenter clinical trials
 
ADDITIONAL RESOURCES
World Health Organization
 
(B) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
(C) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 16
 
Council for International Organizations of Medical Sciences (CIOMS)
 
REQUIREMENTS
(1) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 3.2, and Screening Form
 
(2) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 7.0, 7.2.5, 7.2.12, 7.2.13, 7.3, and 8.0
 
(3) (Legislation) Pharmacy, Medicines and Poisons Act (PMPA) (January 15, 1991)
Ministry of Health
 
Relevant Sections: Part IV (Sections 34 and 35) and Pharmacy, Medicines and Poisons Regulations (Part IV (Sections 11 and 12))
 
(4) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 3, 5, and 6
 
(5) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 4 Sites & Investigators (Sections 4.5, 4.6, and 8) and Checklist of Required Documents (Appendices 1, 8, 10, and 11)
 
Clinical Trial Lifecycle > Safety Reporting
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
In accordance with the G-SAEs, the following definitions provide a basis for a common understanding of Malawi’s safety reporting requirements:
  • Adverse Event (AE) – Any AE associated with the use of a medicine in humans, and which does not necessarily bear a causal relationship to the treatment. This may include an AE occurring in the following  circumstances: during use in professional practice; from an overdose, whether accidental or intentional; from drug abuse; from drug withdrawal; and as a result of any failure of expected pharmacological action
  • Adverse Drug Reaction (ADR) – A reaction characterized by the suspicion of a causal relationship between the drug and the occurrence
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – An adverse experience occurring at any dose that results in death, is life-threatening, requires or extends patient hospitalization, results in persistent or significant disability, is a birth defect or congenital anomaly; or is an important medical event that, based upon appropriate medical judgment, may jeopardize the participant, and may require intervention to prevent one of the listed outcomes.
Reporting Requirements for AEs/ADRs
As stated in the G-SAEs, the sponsor or the investigator(s) is required to report all SAEs/SADRs that meet the Pharmacy, Medicines and Poisons Board’s (PMPB) reporting requirements within 24-48 hours of site awareness, and submit the SAE form within three (3) working days. All deaths that are assessed as definitely, probably, or possibly related, must be reported to the PMPB within 24 hours of site awareness, and the SAE form must be submitted within three (3) working days of site awareness. Additionally, per Additional Resource (B), for studies conducted under the College of Medicine Research and Ethics Committee (COMREC)’s jurisdiction, the sponsor or investigator is responsible for reporting all SAEs within 24 hours of occurrence. Electronic copies can be submitted to the Secretariat at comrec@medcol.mw followed by hard copies.

Form Completion & Delivery Requirements
As per the G-SAEs, all SAEs/SADRs must be reported on an SAE Form (See Additional Resource (A)) and be submitted to the PMPB office by fax or be hand delivered to the offices at the following address:

The Registrar
Pharmacy, Medicines and Poisons Board
P.O. Box 30241
Lilongwe 3, Malawi

Tel: 265-1755166/165
Fax: 265-1755204

A sample SAE form is available in Additional Resource (A).

Data and Safety Monitoring Board
As per the G-CTAProcsVacBiol, a Data Safety Monitoring Board (DSMB) or a similar body must be established and empowered to regularly assess the trial and to recommend a pause or termination of the trial for safety reasons.
 
Per Additional Resource (B), COMREC requires DSMBs to be instituted for all clinical studies involving humans where:
  • The investigation of a research question has direct implications for clinical care or public health, including all Phase III trials
  • The population is classified as highly vulnerable
  • The trials involve high risk intervention for large multicenter clinical trials
ADDITIONAL RESOURCES
(A) (Form) Serious Adverse Event Form (Form CT 11) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 16 and 21
 
REQUIREMENTS
(1) (Guidance) Serious Adverse Events (SAEs) Reporting Manual for Clinical Trials in Malawi (G-SAEs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 62, and 2
 
(2) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 8 Trial Conduct Monitoring and Reports
 
Clinical Trial Lifecycle > Progress Reporting
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Last content review/update: October 24, 2017. Submit updates or comments.
SUMMARY
Overview
As delineated in the G-NHSRC and the G-COMREC, the investigator(s) is responsible for submitting progress and final reports on the status of a clinical trial to either one of the two government authorized ethics committee(s) (EC), the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC).

Interim/Progress Reports
According to the G-NHSRC, the NHSRC requires an initial submission of a progress report within three (3) months of approval of the study.
 
The G-NHSRC and the G-COMREC state that all approved studies continuing for more than one year are subject to an EC continuing review. As part of this review, investigator(s) are required to submit a progress report describing the number of participants enrolled, any problems that occurred during the prior approval period, any new knowledge regarding the study, and any procedural changes. 
 
According to the G-NHSRC, G-COMREC, and Additional Resource (B), if an annual progress report is not submitted within one (1) month following the expiration date, then annual ethics approval will lapse, rendering the study unethical if research continues, and the EC will order the investigator to stop the study unless it is necessary for the welfare of the participants. Per the G-NHSRC, if the investigator wants to continue a study that has lapsed for two (2) months, he or she must submit a new application for review by NHSRC and wait for approval before resuming research under the protocol.
 
Final Report
As stated in Additional Resource (B), and as required by the G-NHSRC and the G-COMREC, the investigator is required to submit a final report to the EC when a study is completed.
 
According to the G-NHSRC, the investigator must submit three (3) copies of the final technical report when submitting written notice of the completion of the study.

Furthermore, the G-NHSRC states that all data originating from a research study conducted in Malawi are the property of the Malawi Government irrespective of the source of funds for carrying out the study. Therefore, investigators are required to submit copies of their reports to the NHSRC for review prior to submitting for publishing within or outside of Malawi. Investigators are expected to have plans for disseminating research findings in Malawi.
 
Per Additional Resource (B), the requirement for the investigator to provide research results to COMREC can be fulfilled in the form of a journal article. Additionally, an investigator should complete and submit a COMREC close-out form which can be accessed from the COMREC secretariat.
 
ADDITIONAL RESOURCES
(A) (Form) COMREC Progress Report Form (Date Unavailable)
College of Medicine Research and Ethics Committee
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 19 and 22
 
REQUIREMENTS
(1) Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.1.2, 5.1.5, 5.6, and 11
 
(2) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.5 and 6.0
 
Sponsorship > Definition of Sponsor
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Last content review/update: October 09, 2017. Submit updates or comments.
SUMMARY
Overview
As per the D-ImprtRelIMPs, a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with G-COMREC, the Malawi government, which complies with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs)’s definition of sponsor, also permits a sponsor to transfer any or all of his/her trial-related duties and functions to a contract research organization (CRO). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities to be transferred and assumed by a CRO should be specified in a written agreement or contract.

A sponsor may be domestic or foreign. As specified in the R-HlthResCoord, a sponsor that is a foreign company, organization, or individual(s), must first be affiliated with a local Malawian institution that is recognized by the National Commission for Science and Technology (NCST) prior to commencing any operations in the country.
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.53 and 5.2
 
REQUIREMENTS
(1) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 7
 
(2) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 9.0
 
(3) (Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 10.0
Sponsorship > Trial Authorization
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SUMMARY
Overview
In accordance with the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the R-HlthResCoord, the sponsor or the principal investigator (PI) is responsible for submitting a clinical trial application to the Pharmacy, Medicines and Poisons Board (PMPB) to obtain approval to conduct a study.

To complete the clinical trial application package, the sponsor or the PI must use the PMPB’s clinical trial application form listed in Additional Resource (A). In addition to the completed application, the sponsor or the PI must also provide the ethics committee approval letter, clinical protocol, the participant information leaflet and informed consent form, a signed declaration by the investigators, a certificate of good manufacturing practice for the manufacture of the trial medicine, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.
 
ADDITIONAL RESOURCES
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 2 Basic Administrative Data on the Application and Checklist of Required Documents
 
(2) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, and 3.2
 
(Regulation) National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (R-HlthResCoord) (Revised Edition) (November 2012)
National Commission for Science and Technology
 
Relevant Sections: 8.0
 
Sponsorship > Insurance
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
As set forth in the G-CTInsurance, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and Additional Resource (D), the sponsor or the investigator(s) are responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance or indemnify the investigator and the institution against claims arising from malpractice or negligence. See the G-CTInsurance, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and Additional Resource (D) for detailed information when insurance is required.

As per the G-CTInsurance, the sponsor or the investigator(s) must provide the participants with a no-fault insurance policy and certificate for the duration of the trial, and for five (5) years following the trial’s completion. “No-fault” is defined as insurance for which proof of negligence or other wrongful conduct need not be established. However, the causal connection between the trial and harm, bodily injury, or death must be proven to trigger the obligation to make a compensation payment. The National Health Sciences Research Committee (NHSRC), the College of Medicine Research and Ethics Committee (COMREC), or the Pharmacy, Medicines and Poisons Board’s (PMPB) Clinical Trial Review Committee are responsible for determining which clinical trials fall within the scope of this requirement.
 
Per the G-CTInsurance, obtaining and submitting insurance is a requirement and a prerequisite to obtaining clinical trial ethics and regulatory approval. The insurance documentation must be included as part of the application package submitted to either the NHSRC or the COMREC, and the PMPB. As specified in the G-CTAProcsVacBiol, the sponsor or the investigator(s) must also comply with the insurance and compensation requirements delineated in the Association of the British Pharmaceutical Industry’s guidelines (Additional Resources (B) and (C)).

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.
 
ADDITIONAL RESOURCES
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Association of the British Pharmaceutical Industry, United Kingdom
 
Association of the British Pharmaceutical Industry, BioIndustry Association, and Clinical Contract Research Association, United Kingdom
 
Relevant Sections: 3 and 4
 
(D) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 15
 
REQUIREMENTS
(1) (Guidance) National Policy Requirement and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi (G-CTInsurance) (Revised 2nd Edition) (December 2012)
National Commission for Science and Technology
 
Relevant Sections: 1.0, 2.0, and 3.0
 
(2) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 9 Insurance, Checklist of Required Documents (Appendix 9), and Check of Appended Documents (Appendix 9)
 
(3) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 2, 3.2, and Screening Form
 
(4) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 9.0
 
Sponsorship > Compensation
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SUMMARY
Overview
As specified in the G-CTInsurance, the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the G-COMREC, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death.

As per the G-CTAProcsVacBiol, the sponsor must follow the principles set forth in the Association of the British Pharmaceutical Industry’s guidelines (Additional Resources (A) and (B)) to comply with Malawi’s participant compensation and treatment requirements due to trial-related injuries.

The guidelines state that the sponsor should furnish written assurance to the investigator that he/she will agree to pay compensation to participants and/or his/her legal heirs in the event of trial-related injuries or death. The investigator, in turn, communicates this information to the relevant ethics committees (ECs).

Compensation Principles
Additional Resource (A) provides several basic principles to guide sponsors in fulfilling their compensation obligations. Compensation should be paid as follows:
  • When it can be demonstrated that a causal relationship exists between a participant’s injury and his/her participation in a trial
  • When a child is injured in utero through his/her mother’s participation in a clinical trial
  • When the injury results in permanent injury or disability to the participant
  • When there is an adverse reaction to a medicinal product under trial, and injury is caused by a procedure adopted to deal with that adverse reaction
The likelihood of an adverse reaction, or the fact that the participant has freely consented (whether in writing or otherwise) to participate in the trial should not exclude him/her from being eligible for compensation. (See the aforementioned guidelines and the Informed Consent topic, Compensation Disclosure subtopic for additional information on a participant’s right to compensation.)

Payment Procedures and Requirements
According to Additional Resource (A), the amount of compensation to be paid to the participant should be appropriate to the nature, severity, and persistence of the injury. The compensation should also be generally consistent with the amount of damages commonly awarded for similar injuries.

The amount paid in 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
In any case where the sponsor agrees to pay the participant, but the two (2) parties differ on what is the appropriate level of compensation, it is recommended that the sponsor agree to seek at his/her own cost, the opinion of a mutually acceptable independent expert. This opinion should then be made available to the participant(s), and the expert’s opinion should be given substantial weight by the sponsor in reaching a decision on the payment amount.

Additionally, any participant claims pursuant to Additional Resource (A), should be made to the sponsor, preferably via the investigator. The participant should include details on the nature and background of the claim which the sponsor should review expeditiously. The review process may be delayed if the participant requests an authority to examine any medical records relevant to the claim.
 
ADDITIONAL RESOURCES
Association of the British Pharmaceutical Industry, United Kingdom
 
Association of the British Pharmaceutical Industry, BioIndustry Association, and Clinical Contract Research Association, United Kingdom
 
Relevant Sections: 3 and 4
 
REQUIREMENTS
(1) (Guidance) National Policy Requirement and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi (G-CTInsurance) (Revised 2nd Edition) (December 2012)
National Commission for Science and Technology
 
Relevant Sections: 1.0, 2.0, 3.0, and 7.0
 
(2) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 5 Participants, CTA Section 9 Insurance and Checklist of Required Documents (Appendix 9), and Check of Appended Documents (Appendix 9)
 
(3) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 3.2 and Screening Form
 
(4) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 9.0
 
Sponsorship > Quality, Data & Records Management
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SUMMARY
Overview
The Malawi government complies with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs)’s 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. 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.

The sponsor must also obtain the investigator(s)’ and the institution(s)’ agreement to:
  • conduct the trial in compliance with the ICH-GCPs, 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
See also Additional Resource (B) for a detailed checklist of Pharmacy, Medicines and Poisons Board (PMPB) Good Clinical Practice (GCP) inspection requirements.

Electronic Data Processing System
As per ICH-GCPs, 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, and that he/she maintains SOPs for using these systems.

Record Management
As set forth in the ICH-GCPs, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

Audit Requirements
As part of its QA system, the G-CTAProcsVacBiol and the ICH-GCPs note that the sponsor should perform a clinical trial audit. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. 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 PMPB to review. No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
The ICH-GCPs state that if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigator(s)/institution(s), and the PMPB of the termination or suspension, and explain the reason(s) for the termination or suspension. The EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution. Refer to Additional Resource (C) for a link to the National Health Sciences Research Committee (NHSRC)’s protocol termination form.

Multicenter Studies
As delineated in the ICH-GCPs, 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 PMPB, and given ethics committee approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, on complying with a uniform set of standards to assess clinical and laboratory findings, and on completing the CRFs
  • Communication between investigators is facilitated
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 5.1, 5.5, 5.6, 5.19, and 5.23
 
(B) (Checklist) GCP Inspection Checklist (July 2007)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
National Health Sciences Research Committee
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 8 Trial Conduct Monitoring and Reports
 
Sponsorship > Site/Investigator Selection
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SUMMARY
Overview
The Malawi government complies with the requirements delineated in the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) and the G-CTAProcsVacBiol for conducting clinical trials. As set forth in the ICH-GCPs, the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The ICH-GCPs and the G-CTAProcsVacBiol also specify that the sponsor must ensure 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 and the G-CTAProcsVacBiol, 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. If a multicenter trial is going to be conducted, the sponsor must organize a coordinating committee or select coordinating investigators.

Although not specified as a sponsor requirement, the G-CTAProcsVacBiol states that a Data Safety Monitoring Board (DSMB) or a similar body must be established and empowered to regularly assess the trial and to recommend a pause or termination of the trial for safety reasons.
 
Per Additional Resource (B), the College of Medicine Research and Ethics Committee (COMREC) requires DSMBs to be instituted for all clinical studies involving humans where:
  •  The investigation of a research question has direct implications for clinical care or public health, including all Phase III trials
  • The population is classified as highly vulnerable
  • The trials involve high risk intervention for large multicenter clinical trials
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.18, 5.6, and 5.7
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 16
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 4 Sites & Investigators and Checklist of Required Documents (Appendix 10)
 
Informed Consent > Documentation Requirements
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SUMMARY
Overview
In all Malawian clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the G-NHSRC, the G-COMREC-IC, the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), and Additional Resource (B). As per the G-NHSRC, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and the ICH-GCPs, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by one (1) of the two (2) government-approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC), and provided to the Pharmacy, Medicines and Poisons Board (PMPB) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on contents to be included in the form.)

The G-NHSRC, the G-COMREC-IC, Additional Resource (B), and the ICH-GCPs state that the participant and/or his/her legal representative(s) or guardian(s) must be provided with detailed research study information. Per the G-NHSRC, the ICF content should be presented orally and in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education.
 
Language Requirements
As stated in the G-NHSRC, the G-COMREC, the G-COMREC-IC, and Additional Resource (B), the ICF should be written in English and Chichewa (or other relevant local languages) the participant is able to understand.

Documentation Copies
The G-NHSRC and the ICH-GCPs specify that the participant and/or the participant’s legal representative(s) or guardian(s) must sign the ICF. Where the participant is illiterate, the ethics committee (EC) will permit the participant to provide a thumb print in the presence of a witness, who must also sign the ICF. The NHSRC also permits the participant to provide verbal consent in cases where he/she is illiterate. However, the script or information sheet to be read to the potential participant must be approved by the NHSRC and be signed for by the participant’s legal representative(s) and/or guardian(s).
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.28, 2, 3.1.2, and 4.8
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 4 and 15
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.1, 6.2, and 7.0
 
(2) (Guidance) Informed Consent Guidelines (G-COMREC-IC) (Date Unavailable)
College of Medicine Research and Ethics Committee
 
(3) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 10 Description of the Trial and Checklist of Required Documents (Appendix 4), Check of Appended Documents (Appendix 4)
 
(4) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: Screening Form
 
(5) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.0
 
Informed Consent > Required Elements
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SUMMARY
Overview
As delineated in the G-NHSRC and G-COMREC, prior to beginning a clinical trial, the sponsor or the principal investigator (PI) is required to obtain ethics committee (EC) approval from one (1) of the two (2) government-approved ECs, the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC), 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-NHSRC and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) state that information about the research study should be clearly presented in both written and oral form.

No Coercion
As per the G-NHSRC, Additional Resource (B), and the ICH-GCPs, 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-NHSRC, the G-COMREC-IC, the ICH-GCPs, and Additional Resource (B), the ICF should include the following statements or descriptions, as applicable:
  • The study purpose, procedures, and duration
  • Experimental aspects of the study
  • The expected duration of the participant's participation
  • Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Any expected benefits to the participant, others, or to the country as a whole that may reasonably be expected from the research
  • Description of procedures that will be followed
  • Identification of any experimental procedures
  • Disclosure of alternate procedures or treatments available to participants that might be advantageous to the participant
  • Compensation and/or treatment available for the participant in the case of trial-related injury
  • That participation is voluntary, and that the participant can refuse to participate or withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • The extent to which confidentiality of records identifying the participant will be maintained
  • Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
  • That 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
  • Any additional costs to the participant that may result from participation in the research
  • The last sentence should explicitly read “I voluntarily agree”
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
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.28, 2, 3.1.2, and 4.8
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 4
 
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.1, 6.2, 7.0, and 7.1
 
(2) (Guidance) General Guidelines on Health Research College of Medicine Research and Ethics Committee (COMREC) (G-COMREC) (September 29, 2010)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 5.0
 
(3) (Guidance) Informed Consent Guidelines (G-COMREC-IC) (Date Unavailable)
College of Medicine Research and Ethics Committee
 
Informed Consent > Compensation Disclosure
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SUMMARY
Overview
In accordance with the G-NHSRC, the G-COMREC-IC, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), for research involving more than minimal risk, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment available to a participant in the event of injury. (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.)
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 4.8
 
(B) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 4
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 7.1
 
(2) (Guidance) Informed Consent Guidelines (G-COMREC-IC) (Date Unavailable)
College of Medicine Research and Ethics Committee
 
Informed Consent > Participant Rights
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SUMMARY
Overview
In accordance with the Declaration of Helsinki, principles set forth in the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) and the G-NHSRC, Malawi’s ethical standards 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-NHSRC, the G-COMREC-IC, and the ICH-GCPs, 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-NHSRC, the G-COMREC-IC, and the ICH-GCPs, 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-NHSRC, the G-COMREC-IC, and the ICH-GCPs, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal
The G-NHSRC, the G-COMREC-IC, and the ICH-GCPs state 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 and/or to appeal against a violation of his/her rights. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare
The Malawi government complies with the ICH-GCPs 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
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 2, 3, and 4.8
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 2, 6.2, and 7.1
 
(2) (Guidance) Informed Consent Guidelines (G-COMREC-IC) (Date Unavailable)
College of Medicine Research and Ethics Committee
 
Informed Consent > Special Circumstances/Emergencies
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SUMMARY
Overview
The Malawi government, which complies with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances, including medical emergencies.

Medical Emergencies
As per the ICH-GCPs, 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 the prior consent of the participant or his/her legal representative(s) or guardian(s) cannot be obtained, the ethics committee must provide documented approval in order to protect the participant’s rights, safety, and well-being, pursuant to the applicable regulations. The participant or his/her legal representative(s) or guardian(s) should provide consent as soon as possible.

Waiver of Consent
As delineated by the G-NHSRC, although voluntary informed consent is always a requirement for every research proposal, this obligation can be waived by the ethics committee (EC) if such studies have protections in place for both privacy and confidentiality and do not violate the rights of the participants.

As per the G-NHSRC, in addition to the preceding requirements, a waiver may be justified if the research being conducted meets one (1) of the following conditions:
  • It involves only minimal risk, and involves no procedures for which written consent is normally required outside of the research context
  • The research could not practically be carried out without the consent waiver, and obtaining informed consent is not practicable
  • The consent document is the only link between the participant and the research, and the principal risk of harm would come from a breach of confidentiality
  • The waiver is consistent with the participant’s rights
In lieu of a signed ICF, the National Health Sciences Research Committee (NHSRC) may require investigator to provide participants with a written statement regarding the research in the form of an information/fact sheet. See the G-NHSRC for additional information.
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 4.8.15
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 7.0 and 7.4
 
Informed Consent > Vulnerable Populations
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SUMMARY
Overview
As per the G-NHSRC, in all Malawian 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-NHSRC and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) characterize vulnerable populations as those who are relatively or absolutely incapable of protecting their own interests due to illiteracy, a lack of education, autonomy, resources, or other necessary attributes. These participants may include children, pregnant women, prisoners, refugees, orphans, sex workers, people living with HIV and AIDS, persons with mental disabilities, and persons in dependent relationships (e.g., some women who culturally must ask their husbands before consenting to participate in a research study).

The G-NHSRC specifies that the National Health Sciences Research Committee (NHSRC) members must pay special attention to protecting participants who are from vulnerable populations.

As per the G-NHSRC, trials involving vulnerable persons require the research to be directly related to the specific conditions of the vulnerable population involved, and that the participants should personally benefit from the research. In addition, the following elements must be considered when studies are conducted using vulnerable populations:
  • The methods of recruitment, selection, and inclusion/exclusion criteria, as well as informed consent, data confidentiality, and the participant’s willingness to volunteer
  • Group characteristics such as economic, social, physical, environmental, and cultural conditions
  • Applicable local laws that bear on the decision-making abilities of potentially vulnerable participants
  • Research studies involving potentially vulnerable population groups should have adequate procedures in place for assessing and ensuring participants’ capacity, understanding and informed consent or assent
  • Safeguards may include NHSRC monitoring of the consent process where possible
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.
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 1.61
 
REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 5.2.1 and 9.2
 
Informed Consent > Children/Minors
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
The G-NHSRC states that a child is a person less than 18 years of age. As per the G-NHSRC, 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). Assent must also be obtained from a child who is deemed capable of providing assent, and the information presented to the child must be tailored to his/her comprehension level.

As per the G-NHSRC, an ethics committee (EC) bases its assessment of a child’s ability to assent on his/her age, maturity, and psychological state. An EC is granted wide discretion in determining whether a child is capable of assenting, and can waive the requirement for child assent under the following circumstances:
  • If a child is not capable of assent
  • If the research offers the prospect of a direct benefit not available outside of the research (thus falling under the scope of parental authority in overriding a child’s desires)
In certain cases, the National Health Sciences Research Committee (NHSRC) may regard assent by children to represent informed consent without requiring the signature from a legal representative or guardian. A typical case is when the children are emancipated, and may include those that are legally married or are university students under the age of 18.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Sections: 7.0 and 9.2
 
Informed Consent > Pregnant Women, Fetuses & Neonates
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Prisoners
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > Definition of Investigational Product
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SUMMARY
Overview
As delineated in the D-ImprtRelIMPs, an investigational product is defined as a pharmaceutical form of an active substance 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 unauthorized indication, or when used to gain further information about an approved use.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 7
 
Investigational Products > Manufacturing & Import
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SUMMARY
Overview
According to the PMPA, the D-ImprtRelIMPs, and the G-CTARevVacBiol, the Pharmacy, Medicines and Poisons Board (PMPB) is responsible for authorizing the manufacture of investigational products (IPs) in Malawi. The PMPB will approve the manufacture of an IP after the clinical trial application has been approved.

The PMPB is also responsible for authorizing the import of IPs. As per the G-CTAProcsVacBiol and the G-CTARevVacBiol, the sponsor may apply for an import license at the same time that he/she submits the clinical trial application to the PMPB. The sponsor must complete the cover sheet contained in Annex 1 of the D-ImprtRelIMPs for the importation and release of IPs.

In addition, as per the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the D-ImprtRelIMPs, the PMPB requires the manufacturer to provide the following:
  • Evidence of manufacture under conditions compliant with current codes of Good Manufacturing Practice
  • A release of specifications and tests, including a Certificate of Analysis for each batch of IPs, as well as comparator(s), if applicable
  • A copy of a valid Certificate of Manufacture issued by the regulatory authority in the country of origin
  • A copy of a valid World Health Organization certificate of a pharmaceutical product issued by the regulatory authority in the country of origin

 

ADDITIONAL RESOURCES
World Health Organization
 
World Health Organization
 
Relevant Sections: Annex 3 (b): Certificate of Pharmaceutical Product(s)
 
REQUIREMENTS
(1) (Legislation) Pharmacy, Medicines and Poisons Act (PMPA) (January 15, 1991)
Ministry of Health
 
Relevant Sections: Part IV (Sections 34 and 35) and Pharmacy, Medicines and Poisons Regulations (Part IV (Sections 11 and 12))
 
(2) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 3, 6, and Annex 1
 
(3) (Guidance) Guidelines for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTARevVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 2.1 and 3.2
 
(4) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 3, 5, Checklist of Required Documents (Fees), and Check of Appended Documents (Fees)
 
Investigational Products > IMP/IND Quality Requirements
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SUMMARY
Overview
In accordance with the G-CTAProcsVacBiol, the Malawi government follows the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), and requires the sponsor to provide investigators with an Investigator’s Brochure (IB). The ICH-GCPs 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. The sponsor should also update the IB as significant new information becomes available.

IB Content Requirements
The ICH-GCPs 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; and regulatory and postmarketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Bibliography
See Section 7 of the ICH-GCPs 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 D-ImprtRelIMPs, 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 Investigational Products topic, Manufacturing & Import subtopic, the Pharmacy, Medicines and Poisons Board (PMPB) requires the manufacturer to provide the following:
  • Evidence of manufacture under conditions compliant with current GMPs
  • A release of specifications and tests, including a Certificate of Analysis (CoA) for each batch of IPs, as well as comparator(s), if applicable
  • A copy of a valid Certificate of Manufacture issued by the competent authority in the country of origin
  • A copy of a valid World Health Organization certificate of a pharmaceutical product issued by the competent authority in the country of origin
The D-ImprtRelIMPs states that the CoA should identify the product name or code; the sponsor/company name; batch numbers; expiration dates; date of issue; signature, qualification, and title of responsible person; and the results of physical and analytical tests.

The sponsor should complete the cover sheet in Annex 1 of the D-ImprtRelIMPs, include it with each IP shipment, and use the checklist in Annex 2 to ensure the required documentation is attached.

As delineated in the D-ImprtRelIMPs, the sponsor should also prepare IP shipping instructions, including information about the shipment’s overall physical condition for PMPB review and approval. He/she should provide information on the acceptable storage temperatures and storage conditions.
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 5.12 and 7.0
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: Checklist of Required Documents (Appendix 2)
 
(2) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 5, 6, Annex 1, and Annex 2
 
Investigational Products > Labeling & Packaging
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SUMMARY
Overview
Investigational product (IP) labeling in Malawi must comply with the requirements set forth in the G-CTAProcsVacBiol and the D-ImprtRelIMPs. The D-ImprtRelIMPs states that for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country where the trial is being conducted.

As set forth in the G-CTAProcsVacBiol and the D-ImprtRelIMPs, the following labeling information must be included on the primary package label (or any intermediate packaging), and the outer packaging:
  • “For clinical trial use only” or similar wording indicating the IP is clinical trial material
  • Product name or unique code
  • Storage temperature and conditions
  • Expiration date
  • Sponsor contact details
  • Estimated quantities of each IP
In addition, the D-ImprtRelIMPs states that the IP be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: CTA Section 3 Medicines to be used in the trial
 
(2) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 4
 
Investigational Products > Product Management
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SUMMARY
Overview
As set forth in the G-CTAProcsVacBiol, the Malawi government follows the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R1) (ICH-GCPs), and requires the sponsor to provide investigators with an Investigator’s Brochure (IB). The ICH-GCPs 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. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
As defined in the D-ImprtRelIMPs, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. The sponsor should not supply either party with the IP(s) until he/she obtains the Pharmacy, Medicines and Poisons Board (PMPB) and ethics committee (EC) approvals.

The sponsor 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, receipt, disposition, return, and destruction of the IP(s)
  • Acceptable storage temperatures, conditions, and times for the IP
  • Timely delivery of the IP(s)
Refer to the D-ImprtRelIMPs for detailed sponsor-related IP requirements. (See Additional Resource (B) for the World Health Organization guidance and template used by Malawi).
 
In addition, the PharmG-InvestDrugs states that the pharmacist on the study team is responsible for establishing a central system in the pharmacy for maintaining essential information on study agents. The IB should also be distributed to the clinical sites with the final version of the protocol.

Record Requirements
In accordance with the D-ImprtRelIMPs, the sponsor is required to maintain a system for retrieving IP(s) and document this retrieval process (e.g., for deficient product recall, reclaim after trial completion, expired product reclaim). He/she must also maintain a system for the disposition of unused IP(s) and for the documentation of this disposition. Finally, the sponsor should maintain sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. Moreover, to the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
 
ADDITIONAL RESOURCES
(A) (ICH Guidance) Guideline for Good Clinical Practice E6(R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
 
Relevant Sections: 5.12 and 7.0
 
World Health Organization
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: Checklist of Required Documents (Appendix 2)
 
(2) (Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 1, 3, 4, and 5
 
(3) (Guidance) Pharmacy Guidelines for Investigational Drugs (PharmG-InvestDrugs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: B (13)
 
Specimens > Definition of Specimen
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Last content review/update: September 20, 2017. Submit updates or comments.
SUMMARY
Overview
In Malawi, as per the G-StorExptSpecimens, specimens are defined as human or animal materials, collected directly from humans or animals, including, but not limited to excreta, secreta, blood and its components; tissue and tissue fluid swabs; and body parts being transported for purposes such as research and investigational activities.
 
Specimens are also referred to as human materials or biological products. The G-StorExptSpecimens defines human material as all biological material of human origin, including organs, tissues, bodily fluids, teeth, hair and nails, and substances extracted from such material as DNA or RNA.

Please refer to G-StorExptSpecimens for more specific definitions for selected terms including genetically modified micro-organisms and infectious substances.
 
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS
(1) (Guidance) Regulatory Requirements on Storage and Export of Samples/Specimens Collected from Participants/Clinical Trial Subjects during Clinical Trials for Testing (G-StorExptSpecimens) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Malawi
 
Relevant Sections: 5.4, 5.5, and 5.6
 
Specimens > Import & Export
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SUMMARY
Overview
As delineated in the G-CTAProcsVacBiol, the sponsor must obtain approval from the Pharmacy, Medicines and Poisons Board (PMPB) to import and export human biological specimens into and out of Malawi. The sponsor may apply for an import license at the same time that he/she submits the clinical trial application to the PMPB.
 
In cases where investigators are unable to complete all required tests in Malawi, Additional Resources (A), (B), and (C) state that justification must be provided for the importation and exportation of samples. Additional Resources (A) and (B) further indicate that the College of Medicine Research and Ethics Committee (COMREC) must ensure a material transfer agreement (MTA) is in place that includes the following:
  • Intention of the importation and exportation of samples
  • Duration and location of storage
  • Appropriate informed consent authorizing the exportation and importation
  • Who will have access to the samples
  • Who will be the controlling officer of the samples
  • Ownership of the samples
  • Capacity building
In addition, per Additional Resource (C), COMREC also specifically requires investigators wishing to export biological samples to clearly demonstrate that no local capacity is currently available to analyze the samples.
 
Per the G-GenResReqs, the National Health Sciences Research Committee (NHSRC) requires investigators who wish to export biological/genetic materials to apply for a transfer under an MTA that must be reviewed, approved, and signed for by the NHSRC. The investigator must provide a satisfactory description of how the privacy and confidentiality of the individuals and communities and the safety of such materials will be maintained. Furthermore, an investigator is not permitted to transfer biological/genetic material to another research group locally and internationally unless the NHSRC has approved a collaborative study between the two parties and the material and information provided protects the participants.
 
According to the G-GenResReqs and Additional Resource (E), COMREC and NHSRC samples can be stored for a maximum of five (5) years during which time all tests/analyses approved for that particular study should be concluded. Additional Resource (E) further states that if the sample is to be used beyond five (5) years, an updated COMREC authorization must be provided, which will last another five (5) years before it can be renewed. Any specimens remaining after the five (5) year period must be discarded and safely destroyed immediately after the study is completed.
 
The G-StorExptSpecimens specifies that the sponsor is responsible for shipping specimens, for preparing the required documentation (e.g., nationally authorized import/export permits and dispatch/shipping documents), and for ensuring that the samples collected from research participants are sent through the appropriate carrier to their destination. The sponsor may delegate these functions to the principal investigator (PI). Refer to Annex 1 of the G-StorExptSpecimens for a checklist to be completed by the PI for the proper storage and export of clinical trial samples. As per the G-StorExptSpecimens, the transport of specimens is subject to regulation by the International Air Transport Association.
 
ADDITIONAL RESOURCES
Pharmacy, Medicines and Poisons Board, Ministry of Malawi
 
College of Medicine Research and Ethics Committee
 
(C) (Website) COMREC FAQs (Current as of September 18, 2017)
College of Medicine Research and Ethics Committee
 
Relevant Sections: 17
 
(D) (Form) NHSRC Material Transfer Agreement Form (Date Unavailable)
National Health Sciences Research Committee, Ministry of Health
 
National Commission for Science & Technology
 
REQUIREMENTS
(1) (Guidance) Procedures for Review/Evaluation of Clinical Trial Applications for Vaccines and Biologicals in Malawi (G-CTAProcsVacBiol) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
 
Relevant Sections: 2, 3, 5, 10, and Checklist of Required Documents (Fees)
 
(2) (Guidance) Regulatory Requirements on Storage and Export of Samples/Specimens Collected from Participants/Clinical Trial Subjects during Clinical Trials for Testing (G-StorExptSpecimens) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Malawi
 
Relevant Sections: 3, 6.4, and Annex 1
 
(3) (Guideline) Policy Requirements, Procedures, and Guidelines for the Conduct and Review of Human Genetic Research in Malawi (G-GenResReqs) (September 2012)
National Health Sciences Research Committee
 
Relevant Sections: 4.12
 
Specimens > Consent for Specimens
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SUMMARY
Overview
In accordance with the G-StorExptSpecimens, the G-NHSRC, the G-HlthResConduct, and Additional Resource (A), prior to collecting, storing, or using a research participant’s specimen(s), written consent must be obtained from the participant and/or his/her legal representative(s) and investigators should comply with internationally accepted ethics guidelines for specimen collection and handling.

As per the G-GenResReqs, the G-StorExptSpecimens, and the G-NHSRC, a clear explanation and justification for the collection and import/export of specimens must be provided. The investigator(s) are responsible for clarifying to the participant and his/her legal representative(s) how the sample is to be used, and how the research results might impact their interests. Further, the G-GenResReqs, the G-NHSRC, and Additional Resource (A) state that all forms of studies and testing designed to collect and store biological specimens for future unspecified genetic research/analyses, including any scientific retrospective genetic analyses, is not permitted. The G-StorExptSpecimens, on the other hand, says that consent must also be obtained for storage and for potential future use of the samples.
 
Per the G-NHSRC, investigators should also avoid collecting excess specimens from participants. (See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

Human Genetic Research Consent Requirements
The G-GenResReqs states that the investigator(s) must obtain written consent for human genetic research from the participant and his/her legal representative(s). The informed consent form must include statements on what is being studied and why; details about study procedures; known risks, discomforts, and benefits; and alternatives to participation. In addition, the sponsor or the investigator(s) is required to provide the participant(s), the community(ies), or the tribe(s) with detailed information on how their privacy will be protected, and how the confidentiality of obtained information will be maintained. See the G-GenResReqs for consent requirement details.
 
ADDITIONAL RESOURCES
REQUIREMENTS
(1) (Guidance) Regulatory Requirements on Storage and Export of Samples/Specimens Collected from Participants/Clinical Trial Subjects during Clinical Trials for Testing (G-StorExptSpecimens) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Malawi
 
Relevant Sections: 1, 2, 3, 6.4, and Annex 1
 
(2) (Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
 
Relevant Section: 10.0
 
(3) (Guideline) Policy Requirements, Procedures, and Guidelines for the Conduct and Review of Human Genetic Research in Malawi (G-GenResReqs) (September 2012)
National Health Sciences Research Committee
 
Relevant Sections: 3.4, 4.1, and 4.7
 
(4) (Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
Research Unit, National Health Sciences Research Committee
 
Relevant Sections: 12
 
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