Clinical Research Regulation For Malawi
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
Consent for Specimen
Sources
Requirements
Additional Resources
Forms
QUICK FACTS
Clinical trial application language Unspecified
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required No
In-country sponsor presence/representation required Yes
Age of minors Under 18
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: August 18, 2021
Summary

Overview

As per the PMRAAct, the Pharmacy and Medicines Regulatory Authority (PMRA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Malawi. MWI-47 indicates that in accordance with the PMRAAct, the PMRA has replaced the Pharmacy, Medicines and Poisons Board (PMPB) as of October 1, 2019, and the PMRA is currently in the process of developing regulations for the PMRAAct. (Note: While the PMRA continues to update its website and develop new regulations, ClinRegs will continue to reference PMPB documents. New PMRA regulations will be incorporated into the Malawi profile as they become available.)

According to the PMRAAct, the Ministry of Health (MOH) established and manages the PMRA, which is overseen by the Minister of Health. The MOH grants authority to PMRA to monitor the registration and quality of drugs in Malawi. Further, per MWI-45, the PMRA’s registration department registers clinical trials; issues import permits; conducts pharmacovigilance; and registers medicinal products and pharmacy personnel and businesses. The PMRAAct indicates that the PMRA is composed of part-time members appointed by the Minister, including:

  • The Secretary for Health or his/her representative
  • The Solicitor General or his/her representative
  • The Comptroller of Statutory Corporations or his/her representative
  • Three (3) registered pharmacists (preferably who are also members of the Pharmaceutical Society of Malawi)
  • One (1) medical practitioner nominated by the Medical Council of Malawi
  • One (1) member nominated by the Board of Veterinary Surgeons
  • One (1) person nominated by the Nurses and Midwives Council
  • One (1) person representing groups of patients’ rights advocates
  • One (1) person nominated by a public institution of higher learning in health sciences

The Minister must appoint one (1) of the pharmacist members as PMRA chairperson, and the members must elect the vice-chairperson of the PMRA from amongst themselves. Members of the PMRA, other than ex-officio members, hold office for three (3) years and are eligible for reappointment for one (1) further term. See MWI-49 for a list of the current PMRA Board of Directors.

The G-CTARevVacBiol and the G-CTAProcsVacBiol specify that the PMRA 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:

The CTRC chairperson should be nominated by the PMRA, and the vice-chairperson should be nominated by the CTRC.

Please note: Malawi is party to the Nagoya Protocol on Access and Benefit-sharing (MWI-3), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see MWI-35.

Contact Information

As per MWI-46, the PMRA contact information is as follows:

Postal Address:
Pharmacy and Medicines Regulatory Authority
P.O Box 30241
Lilongwe, Malawi

Physical Address:
Off Paul Kagame Road
Next to MRA Offices
Area 5 Lilongwe

Phone: +265 1 755 165
Fax: +265 1 755 204
Email: info@pmra.mw

Part II (Sections 3-7), Part VII, and Part XIII (Section 131)
1, 2, and 3
1, 2, 3, 4, 5, 6, and 7
Regulatory Authority > Scope of Assessment
Last content review/update: August 18, 2021
Summary

Overview

In accordance with the PMRAAct, the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for reviewing and approving clinical trial applications for new drugs, generic drugs, and imported drugs to be registered in Malawi. The PMRA has replaced the Pharmacy, Medicines and Poisons Board (PMPB). (As the PMRA develops new guidance documents, some documents cited in this profile may still refer to the PMPB. ClinRegs will monitor these developments and update the profile accordingly.)

As per the R-HlthResCoord, parallel submissions of a clinical trial application to an ethics committee (EC) and the PMRA 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 PMRA 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). NHSRC reviews proposals from all other researchers and institutions, including those from COM and KCN with national interest.

Clinical Trial Review Process

According to MWI-50, the PMRA receives clinical trial applications through the office of the Director General, and the applicant must submit evidence of ethical clearance from either the NHSRC or COMREC.

The G-CTARevVacBiol and the G-CTAProcsVacBiol indicate that upon receipt of a clinical trial application, the PMRA initially screens the application for completeness. If complete, a PMRA reference number is assigned. The application is then evaluated by three (3) PMRA-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 PMRA Clinical Trial Review Committee (CTRC). The CTRC, in turn, reviews all the available documentation, and provides a recommendation for approval or rejection. The PMRA considers the CTRC’s recommendation and issues a written approval or rejection. MWI-50 further specifies that the PMRA may grant full or conditional approval depending on the nature of the CTRC’s findings. Depending on the study’s risk profile, the PMRA may conduct post-authorization good clinical practice (GCP) inspections for select clinical trials.

(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.)

Part II (Sections 4-5) and Part XIII (Section 131)
8.0-8.3
2 and 3
1, 2, 3, 4, 5, 6, 7.1, and Appendix 11
1
Regulatory Authority > Regulatory Fees
Last content review/update: August 18, 2021
Summary

Overview

According to the PMRAAct, a person who intends to conduct a clinical trial must apply to the Pharmacy and Medicines Regulatory Authority (PMRA) for a clinical trial certificate upon payment of the prescribed fee.

Per the PMPBFees, the sponsor is responsible for paying a $4,000 non-refundable clinical trial application and registration fee for registered or unregistered products in any phase. In addition, the stated fee to amend the application is $200 USD, and the annual renewal fee is $1,500 USD.

Please note that these fees may have changed. The PMRA is currently developing new regulations for the PMRAAct. ClinRegs will update the Malawi profile as new information becomes available.

Part VII (Section 75)
11
Ethics Committee > Ethics Committee
Last content review/update: August 18, 2021
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 per the R-HlthResCoord, the G-HlthResConduct, the G-NHSRC, the G-COMREC, MWI-5, MWI-50, and MWI-31, 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. 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 single-center studies involving or originating from COM and KCN faculty members and students, and their collaborators/coinvestigators/affiliates. Per MWI-30, each EC has members representing the other committee as a way of ensuring that the activities of the two (2) committees are well coordinated and harmonized. The two (2) ECs report to and are centrally monitored by the NCST.

Ethics Committee Composition

As per the SciTechAct and the G-NHSRC, 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 (1) lay person, as well as members from the following organizations:

  • National Research Council of Malawi (one (1) member)
  • Ministry of Health (MOH) headquarters (two (2) members)
  • COMREC (two (2) members)
  • Community Health Sciences Unit (one (1) member)
  • National AIDS Commission (one (1) member)
  • Center for Social Research (one (1) member)
  • Queen Elizabeth Central Hospital (one (1) member)
  • Zomba Central Hospital (one (1) member)
  • Lilongwe Central Hospital (one (1) member)
  • Christian Health Association of Malawi (one (1) member)
  • Mzuzu University (one (1) member)
  • Mzuzu Central Hospital (one (1) member)
  • Nurses and Midwives Council of Malawi (one (1) member)
  • Ministry of Justice (one (1) member)

The members elect the chairperson and the vice-chairperson.

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 NHSRC, and is responsible for preparing materials and meeting logistics. At least half of NHSRC must be present to conduct a review. 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, reports, 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 COMREC meets every month.

Additional criteria for EC membership are available in the G-NHSRC and the G-COMREC.

Part III
2.0
1.0, 2.0, 3.0, 3.1, 3.2, 3.3, 4.0, 5.7, and 8.0
1 and 7
1.0, 3.1, 3.2, 3.3, and 5.3
Ethics Committee > Scope of Review
Last content review/update: August 18, 2021
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. As shown in MWI-27, the ECs’ scope of review includes whether research is in accordance with national policy requirements, procedures, and guidelines for the conduct of health and social sciences, as well as the international guidelines, the Declaration of Helsinki (MWI-42) and The Belmont Report (MWI-23).

Per the G-NHSRC, the G-COMREC, and the G-HlthResConduct, NHSRC and 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). NHSRC and 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 and Medicines Regulatory Authority (PMRA) 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 the NHSRC or COMREC prior to submitting an application to the PMRA 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. See MWI-52 and MWI-44 for the NHSRC and COMREC amendment request forms, respectively. Any changes cannot be implemented until approved by the EC.

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 COMREC for ethical review and approval. MWI-28 also indicates that COMREC prefers the investigator apply for ethics approval first from an external/overseas EC.

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 MWI-28, 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 (ICH)'s Guideline for Good Clinical Practice E6(R2) (MWI-22), human subjects protection guidelines (e.g., Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects (MWI-19)), the good clinical laboratory practices guidelines, and applicable regulatory requirements. Per MWI-43, while there is not yet a formal requirement to implement the ICH's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it.

MWI-53 indicates that the NHSRC follows, at a minimum, the regulations set forth in the Declaration of Helsinki (MWI-42) and CIOMS guidelines as the criteria for continuing review of a study. The PI is responsible for timely submission of a continuing review application to prevent any lapse in NHSRC approval. NHSRC regulations do not provide for exceptions to the requirement for continuing review. The continuing review application form is available at MWI-53.

7.0, 7.2.5, 7.2.12, 7.2.13, 8.1, 8.2, 8.3, and 8.6
1.0, 3.2, 3.3.4, 5.1, 5.4, and 5.5
1, 2, 3, 4, 5, and 6
7 and 9
1.0, 2.0, 3.1, 5.1.4, 5.1.5, 6.2, and 9.2
1.25, 4, 5.5
20
Ethics Committee > Ethics Committee Fees
Last content review/update: August 18, 2021
Summary

Overview

According to the G-NHSRC, the G-COMREC, the R-HlthResCoord, and the G-HlthResConduct, the two (2) national health research ethics committees (EC) in Malawi—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, the G-HlthResConduct, and MWI-5, 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. MWI-5 further clarifies that the fees above and the Pharmacy and Medicines Regulatory Authority (PMRA)'s Clinical Trial Review Committee (CTRC) fees are included in the 10%. Payment of the 10% fee must be made for all EC-approved research projects prior to commencement of the research study.

COMREC Fees

As per MWI-5 and MWI-28, COMREC charges a $150 USD, or 500 Malawian Kwacha for Malawian researchers, a fee to assist with administrative costs for processing the protocol submission and communicating with reviewers and researchers. According to the G-COMREC, eligible investigators may apply to management for exemption from paying this processing fee. MWI-5 and MWI-28 state that COMREC is also mandated to charge a College of Medicine research administration fee of 10% of the total budget for each research protocol that it reviews. As indicated in MWI-1, MWI-5, and MWI-28, the College of Medicine’s Dean of Postgraduate Studies and Research can grant waivers for the 10% research and administration fees.

7.2.10, 7.2.11, and 7.2.12
3.3.10
8
8.0
11-14
Ethics Committee > Authorizing Body
Last content review/update: August 18, 2021
Summary

Overview

As mandated by the SciTechAct, 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.

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’ (EC) guidelines and standard operating procedures
  • Monitoring the ECs’ performance and adherence to relevant national policies, laws, regulations, and guidelines

Ethics Committee Composition

As delineated in MWI-37 and MWI-38, the NCST is governed by a board with a maximum of 15 commissioners consisting of the following:

  • One (1) chairperson, appointed by the Ministry of Health (MOH)’s Minister of Health
  • Nine (9) Minister of Health-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
  • Five (5) permanent secretaries or their representatives who are ex-officio members, and represent ministries relevant to science and technology
  • The NCST Director General, who acts as the secretary of the board

In addition, a vice-chairperson is elected by the board from among its members. An ex-officio member cannot be elected as a vice-chairperson.

For detailed information on the NCST composition and responsibilities, see MWI-37 and MWI-38.

Registration, Auditing, and Accreditation

No information is available on registration, auditing, and accreditation responsibilities by the NCST.

Part III (5)
2.0 and 2.2
Clinical Trial Lifecycle > Submission Process
Last content review/update: August 18, 2021
Summary

Overview

According to the G-CTARevVacBiol, the R-HlthResCoord, and MWI-50, the Pharmacy and Medicines Regulatory Authority (PMRA) requires the sponsor or the principal investigator (PI) to obtain PMRA approval and ethics committee (EC) approval of a clinical trial application.

As stated in the R-HlthResCoord and the G-HlthResConduct, 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 PMRA for review and approval. According to MWI-50, the PMRA receives clinical trial applications through the office of the Director General, and the applicant must submit evidence of ethical clearance from either the NHSRC or COMREC. (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 COMREC for ethics review and approval. MWI-28 also indicates that COMREC prefers the investigator apply for ethics approval first from an external/overseas EC.

In the case of multicenter studies, per the R-HlthResCoord, 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. 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 NHSRC and COMREC. Checklists (see MWI-4 and MWI-1) must be completed and submitted to the NHSRC or COMREC along with the protocols. Refer to MWI-28 and MWI-1 for detailed COMREC submission requirements.

Delivery Address for Research Protocol

According to MWI-51, new protocol submissions to the NHSRC should be made through the Proposal Review System (MWI-48).

Per the G-HlthResConduct and MWI-15, research protocols and relevant materials should be submitted to the NHSRC at the following address:

The Chairperson
National Health Sciences Research Committee
Ministry of Health
P.O. Box 30377
Lilongwe 3, Malawi

Tel: +265 1 789 400/414, +265 1 726 422/418
Fax: +235 1 789 527/536
Email: mohdoccentre@gmail.com (per MWI-55)

MWI-1 indicates that for submissions to COMREC, all documents should be submitted in one (1) PDF file by email to comrec@medcol.mw, if the file size does not exceed 5MB. If the file size is over 5MB, then the file should be sent as a compressed zipped file.

Delivery Address for Clinical Trial Application

MWI-46 provides the following contact information for the PMRA:

Postal Address:
Pharmacy and Medicines Regulatory Authority
P.O Box 30241
Lilongwe, Malawi

Physical Address:
Off Paul Kagame Road
Next to Malawi Revenue Authority Offices
Area 5 Lilongwe

Phone: +265 1 755 165
Fax: +265 1 755 204
Email: info@pmra.mw

Assembly and Number of Copies

As per the G-CTARevVacBiol and MWI-9, applicants must submit three (3) copies of the clinical trial application form to the PMRA.

Clinical Trial Application Language Requirements

There is no specified language requirement for the clinical trial documents to be submitted to the PMRA. MWI-4 and MWI-1 indicate that the data collection tools and informed consent forms submitted to the NHSRC and COMREC must be provided in both English and Chichewa (or the appropriate local language).

7.0, 7.2.5, 7.2.12, 7.2.13, and 8.0-8.1
5.0
1
1 and 8
5.1
1-10
Clinical Trial Lifecycle > Submission Content
Last content review/update: August 18, 2021
Summary

Overview

In accordance with the G-CTARevVacBiol, the R-HlthResCoord, MWI-50, and MWI-28, the sponsor or the principal investigator (PI) must apply to the Pharmacy and Medicines Regulatory Authority (PMRA) 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 PMRA’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.

PMRA Requirements

As per the G-CTAProcsVacBiol and the G-CTARevVacBiol, the following documentation must be submitted to the PMRA:

  • Cover letter
  • Clinical Trial Application (Form CT 8) (See MWI-9)
  • 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 PMRA application submission requirements.

NHSRC Requirements

According to MWI-4, MWI-15, and MWI-51, any proposals submitted to the NHSRC must be accompanied by the following (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • The NHSRC checklist (MWI-4) (20 copies)
  • Cover letter from the PI (20 copies)
  • The NHSRC Application form (MWI-15) (20 copies)
  • Research proposal summary, maximum four (4) pages (20 copies)
  • Full research proposal (see MWI-4 and MWI-15 for details) (20 copies)
  • Data collection instruments in both English and Chichewa (or other appropriate language) (20 copies)
  • Informed consent in both English and Chichewa (or other appropriate language) (20 copies)
  • Letter of approval from foreign EC, where applicable (for all students studying in foreign universities)
  • Support letters from affiliating institutions (e.g., universities, hospitals, research institutions, or companies where the study is going to take place) (20 copies)
  • A copy of the receipt for the paid $150 USD application fee (Malawian students pay 5000 Malawian Kwacha)
  • CVs for all the investigators (20 copies)
  • Approval certificate from the PMRA where the research involves products such as new pharmaceutical products

Per MWI-4, MWI-15, and MWI-51, the submission must be bound as one (1) document, stamped, and signed. If any of the above items are not included in the submission to the NHSRC, an explanation must be provided. Copies of the application package outlined above, plus an electronic copy, must be submitted to the NHSRC Secretariat three (3) weeks before the date of the NHSRC review meeting. Five (5) copies for Malawian student proposals (up to Masters level) must also be submitted to the NHSRC Secretariat for expedited review.

Please note that while the NHSRC checklist (MWI-4) indicates that PMRA approval must be provided, the R-HlthResCoord states that EC approval must be obtained prior to submitting the clinical trial application to the PMRA.

COMREC Requirements

MWI-1 indicates that for submissions to COMREC, all documents should be submitted in one (1) PDF file by email to comrec@medcol.mw, if the file size does not exceed 5MB. If the file size is over 5MB, then the file should be sent as a compressed zipped file. The single PDF file should include the following information in the following order:

  • Completed copy of the COMREC checklist (MWI-1)
  • Cover letter from the PI
  • Protocol
  • Informed consent forms in both English and Chichewa for adult participants ages 18 and above, parental consent forms for all minors, and assent forms (in addition to the parental consent forms) for all minors between the ages of 7 and 17
  • Data collection tools (those that will involve obtaining information from research participants should be translated into Chichewa)
  • Material transfer agreement forms and documents
  • Waiver letter for the 10% College of Medicine overhead fee, if applicable
  • Information regarding whether the research proposal has been submitted to another EC
  • Letter of support from College of Medicine head of the principal department hosting the research
  • Letter(s) of support from heads of all other departments and institutions in which any research work will be done
  • Evidence of current active registration with the Medical Council of Malawi for the PI and other investigators
  • Investigator(s) CV(s)

MWI-1 further indicates that the proposal should not be submitted unless every item on the checklist is included, or unless a reason can be provided for the absence of any item. The completed checklist must be attached to the front of the submission. In addition, as stated in the G-HlthResConduct, the PI is required to submit application materials at least three (3) weeks before the date of the review meeting.

See the G-NHSRC, the G-COMREC, MWI-28, MWI-4, MWI-15, MWI-51, and MWI-1 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 good clinical practice guidelines. Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. The following elements should be included (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • Cover page
  • General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
  • 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 MWI-22 and the G-HlthResConduct.

In addition, the G-NHSRC, the G-COMREC, MWI-15, MWI-51, MWI-4, and MWI-1 delineate the core documentation requirements for submitting a protocol to the NHSRC and COMREC. Checklists (see MWI-4 and MWI-1) must be completed and submitted to the NHSRC or COMREC along with the protocols.

7.0, 7.2.5, 7.2.12, 7.2.13, and 8.0-8.2
5.0
1, 2, 3.2, and Screening Form
Checklist of Required Documents
5 and 7
5.1
6
1-10
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: August 18, 2021
Summary

Overview

The timeline for review involves two (2) distinct approval cycles, one (1) from the appropriate ethics committee (EC), and one (1) 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 and Medicines Regulatory Authority (PMRA) initiating its review and approval process. Parallel submissions of a clinical trial application to an EC and the PMRA 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 COMREC for ethics review and approval. MWI-28 also indicates that 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.)

PMRA Approval

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

As per the G-CTARevVacBiol and the G-CTAProcsVacBiol, once the dossier is submitted to the PMRA, the evaluation process is divided into two (2) phases. The first phase is administrative or quantitative, and requires the PMRA’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) PMRA 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 PMRA 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 PMRA, which is responsible for making the final decision regarding the trial.

Ethics Committee Approval

NHSRC Approval

According to the G-HlthResConduct, the PI is required to submit application materials to the NHSRC at least three (3) weeks before the date of the review meeting.

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, 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 stated in the G-HlthResConduct, the PI is required to submit application materials to the COMREC at least three (3) weeks before the date of the review meeting.

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.

7.0, 7.2.5, 7.2.12, 7.2.13, 8.0-8.2
5.0, 5.1, and 5.9
1, 2, and 3
2, 3, 4, 5, and 6
7
3.3, 4.1, 4.4, 5.1, and 5.2
6
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: August 18, 2021
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 and Medicines Regulatory Authority (PMRA) 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 NHSRC or COMREC for ethical review and approval. No waiting period is required following the applicant’s receipt of these approvals.

In addition, as per the PMRAAct and the D-ImprtRelIMPs, the sponsor is required to obtain an import permit for the shipment of the investigational product (IP) to be used in the trial (See MWI-40 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 research should comply with good clinical practice guidelines. Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. 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.

Ethics Committee 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 NHSRC or 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 Trial Registration

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 MWI-28, 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 clinical trials involve high-risk intervention
  • Large multicenter clinical trials are involved

Per MWI-22, a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Part V (Section 58) and Part X (Section 96)
7.0, 7.2.5, 7.2.12, 7.2.13, 7.3, and 8.0-8.2
1, 3, 5, and 6
1, 3.2, and Screening Form
CTA Section 4 Sites & Investigators (Sections 4.5, 4.6, and 8) and Checklist of Required Documents (Appendices 1, 8, 10, and 11)
1.25, 4, 5.5
16
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: August 18, 2021
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 (1) 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 and Medicines Regulatory Authority (PMRA)'s 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 PMRA within 24 hours of site awareness, and the SAE form must be submitted within three (3) working days of site awareness. Additionally, per MWI-28, for studies conducted under the College of Medicine Research and Ethics Committee (COMREC)’s jurisdiction, the 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 MWI-12). According to MWI-43, the SAE Form can be adapted by the investigators to suit their needs, especially in the case of multicenter clinical trials as long as the essential contents of the form are retained. The form should be submitted to the PMRA office by fax or hand delivered to the offices at the following address:

The Registrar
Pharmacy and Medicines Regulatory Authority
P.O. Box 30241
Lilongwe 3, Malawi
Tel: 265-1755166/165
Fax: 265-1755204

A sample SAE form is available in MWI-12.

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 MWI-28, 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 clinical trials involve high-risk intervention
  • Large multicenter clinical trials are involved

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

CTA Section 8 Trial Conduct Monitoring and Reports
1 and 2
1.25, 5.5, and 5.16
16 and 21
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: August 18, 2021
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 (1) of the two (2) government authorized ethics committee(s) (EC)—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC).

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 notes that the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Interim and Annual Progress Reports

According to the G-NHSRC, 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 (1) 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 MWI-28, 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.

See MWI-54 and MWI-8 for the NHSRC and COMREC report forms, respectively.

Final Report

As stated in MWI-28, 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 to NHSRC.

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 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 MWI-28, 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 closeout form, which can be accessed from the COMREC secretariat.

5.5 and 6.0
5.1.2, 5.1.5, 5.6, and 11
4.10 and 4.13
19 and 22
Sponsorship > Definition of Sponsor
Last content review/update: August 18, 2021
Summary

Overview

As per the D-ImprtRelIMPs and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), 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. Per MWI-43, while there is not yet a formal requirement to implement MWI-22, Malawi is encouraging investigators to follow it. MWI-22 goes on to specify that a sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

In accordance with MWI-22, Malawi permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

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.

10.0
7
1.53, 1.54, 5.1, and 5.2
Sponsorship > Trial Authorization
Last content review/update: August 18, 2021
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 and Medicines Regulatory Authority (PMRA) to obtain approval to conduct a study.

To complete the clinical trial application package, the sponsor or the PI must use the PMRA’s clinical trial application form (see MWI-9). 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.

8.0
1, 2, and 3.2
CTA Section 2 Basic Administrative Data on the Application and Checklist of Required Documents
Sponsorship > Insurance
Last content review/update: August 18, 2021
Summary

Overview

As set forth in the G-CTInsurance, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and MWI-28, 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 MWI-28 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 and Medicines Regulatory Authority (PMRA)'s 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 COMREC, and the PMRA. 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 (MWI-21 and MWI-20).

The PMRA’s Indemnity Form for Conducting Clinical Trials (Form CT 10) is available at MWI-18.

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

9.0
1, 2, 3.2, and Screening Form
1.0, 2.0, and 3.0
CTA Section 9 Insurance, Checklist of Required Documents (Appendix 9), and Check of Appended Documents (Appendix 9)
3 and 4
15
Sponsorship > Compensation
Last content review/update: August 18, 2021
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. Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Per G-BioSampCompense, participants may also be reimbursed for trial-related expenses, if allowed by the ethics committee (EC). However, payments to participants that are construed to affect the voluntary participation of the subjects are not allowed. Furthermore, lump sum payments for research participation are not allowed. Participants who incur direct costs from trial participation must be reimbursed if required by the EC. Such reimbursable expenses include travel and communications costs associated with routine clinical trial evaluations. During review of the protocol, the EC will make a case-by-case determination if the study should provide any form of acceptable recompense.

As per the G-CTAProcsVacBiol, the sponsor must follow the principles set forth in the Association of the British Pharmaceutical Industry’s guidelines (MWI-21 and MWI-20) 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 ECs.

Compensation Principles

MWI-21 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 MWI-21, the amount of compensation 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 MWI-21, 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.

(b)(ii) and (b)(iii)
9.0
3.2 and Screening Form
1.0, 2.0, 3.0, and 7.0
CTA Section 5 Participants, CTA Section 9 Insurance and Checklist of Required Documents (Appendix 9), and Check of Appended Documents (Appendix 9)
3 and 4
4.8 and 5.8
Sponsorship > Quality, Data & Records Management
Last content review/update: August 18, 2021
Summary

Overview

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 guides sponsors on quality, data, and records management.

Per MWI-22, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

  • During protocol development, identification of processes and data that are critical to ensure participant protection and the reliability of trial results
  • Identification of risks to critical trial processes and data
  • Evaluation of the identified risks against existing risk controls
  • Decisions on which risks to reduce and/or which risks to accept
  • Documentation of quality management activities and communication to those involved in or affected by these activities
  • Periodic review of risk control measures to ascertain whether the implemented quality management activities are effective and relevant
  • In the clinical study report, a description of the quality management approach implemented in the trial and a summary of important deviations from the predefined quality tolerance limits and remedial actions taken

See also MWI-2 for a detailed checklist of Pharmacy and Medicines Regulatory Authority (PMRA) Good Clinical Practice (GCP) inspection requirements.

Electronic Data Processing System

As per MWI-22, 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. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to MWI-22 for additional information.

Records Management

As set forth in MWI-22, 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 the 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.

In addition, MWI-22 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Audit Requirements

As part of its QA system, the G-CTAProcsVacBiol notes 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 PMRA to review. No specific timeframe is provided for the audit process.

Per MWI-22, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Premature Study Termination/Suspension

According to MWI-22, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the ethics committee (EC) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor. Refer to MWI-17 for a link to the National Health Sciences Research Committee (NHSRC)’s protocol termination form.

Multicenter Studies

As delineated in MWI-22, 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 given EC approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication among investigators is facilitated
CTA Section 8 Trial Conduct Monitoring and Reports
1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
Sponsorship > Site/Investigator Selection
Last content review/update: August 18, 2021
Summary

Overview

The Malawi government complies with the requirements set forth in the G-CTAProcsVacBiol for conducting clinical trials. The G-CTAProcsVacBiol specifies 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 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.

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 provides guidance to sponsors on investigator and site selection. According to MWI-22:

  • The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicenter trials, their organization and/or selection are the sponsor’s responsibility.
  • Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator’s Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.

Furthermore, the sponsor should obtain the investigator’s/institution’s agreement to:

  • Conduct the trial in compliance with Good Clinical Practices (GCPs), with the applicable regulatory requirement(s), and with the approved protocol
  • Comply with procedures for data recording/reporting
  • Permit monitoring, auditing, and inspection
  • Retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Data and Safety Monitoring Board

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. MWI-22 notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Per MWI-28, 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 clinical trials involve high-risk intervention
  • Large multicenter clinical trials are involved
CTA Section 4 Sites & Investigators and Checklist of Required Documents (Appendix 10)
1.25, 5.5, and 5.6
16
Informed Consent > Documentation Requirements
Last content review/update: August 18, 2021
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 and G-COMREC-IC. The G-BioSampCompense also confirms that a participant’s voluntary informed consent is required. Also, per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. As per the G-NHSRC, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and MWI-22, 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 and Medicines Regulatory Authority (PMRA) 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, MWI-28, and MWI-22 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 MWI-28, the ICF should be written in English and Chichewa or other relevant local languages that the participant is able to understand.

Documentation Copies

The G-NHSRC and MWI-22 specify that the participant and/or the participant’s legal representative(s) or guardian(s) must sign the ICF. The G-NHSRC indicates that where the participant is illiterate, the EC will permit the participant to provide a thumbprint in the presence of a witness, who must also sign the ICF. 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 NHSRC and be signed for by the participant’s legal representative(s) and/or guardian(s).

MWI-22 states that where the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

  • The written ICF and any other written information provided to the participant is read and explained to the participant and his/her legal representative(s) and/or guardian(s)
  • The participant and his/her legal representative(s) and/or guardian(s), have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.

(b)(i)
5.0
Screening Form
CTA Section 10 Description of the Trial and Checklist of Required Documents (Appendix 4), Check of Appended Documents (Appendix 4)
5.1, 6.2, and 7.0
2, 4.4, 4.8, 8.2, and 8.3
4 and 15
Informed Consent > Required Elements
Last content review/update: August 18, 2021
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).

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 provides guidance on the elements to include in the ICF. The G-NHSRC and MWI-22 state that information about the research study should be clearly presented in both written and oral form.

No Coercion

As per the G-NHSRC, MWI-28, and MWI-22, 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. The G-BioSampCompense also confirms that researchers must not duly induce participants to participate in any proposed research. Rather, they must design and implement their studies in a manner that calls for the participants’ informed voluntary consent to participation.

Informed Consent Form Required Elements

Based on the G-NHSRC, the G-COMREC-IC, G-NHSRC-ICF, MWI-22, and MWI-13, the ICF should include the following statements or descriptions, as applicable (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • The study title, purpose, procedures, and duration
  • Experimental aspects of the study
  • The responsibilities and expected duration of the participant's participation
  • The trial treatment(s) and the probability for random assignment to each treatment
  • 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, including data collection, 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
  • The anticipated prorated payment, if any, to the participant for participating in the trial
  • The anticipated expenses, if any, to the participant for participating in the trial
  • 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
  • That the monitor(s), the auditor(s), the EC, and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or the participant's legally acceptable representative is authorizing such access
  • The extent to which confidentiality of records identifying the participant will be maintained
  • Name and contact details of institutions that have approved the study
  • Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
  • EC contact information
  • 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 site of the study
  • Consent and signature, including the last sentence, which should explicitly read “I voluntarily agree”

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

(b)(i)
5.0
5.1, 6.2, 7.0, and 7.1
4.4 and 4.8
4
Informed Consent > Compensation Disclosure
Last content review/update: August 18, 2021
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(R2) (MWI-22) (which Malawi is encouraging investigators to implement until it is formally adopted, per MWI-43), 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. It should also describe the anticipated prorated payment, if any, to the participant for participating in the trial. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements.)

Per G-BioSampCompense, payments to participants that are construed to affect the voluntary participation of the subjects are not allowed. Furthermore, lump sum payments for research participation are not allowed. Participants who incur direct costs from trial participation must be reimbursed if required by the ethics committee (EC). Such reimbursable expenses include travel and communications costs associated with routine clinical trial evaluations.

(b)(ii)
7.1
3.1 and 4.8
4
Informed Consent > Participant Rights
Last content review/update: August 18, 2021
Summary

Overview

Per 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. Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), which addresses participant rights, Malawi is encouraging investigators to follow it.

(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 MWI-22, 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 MWI-22, 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 MWI-22, 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 MWI-22 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 MWI-22 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.

2, 6.2, and 7.1
2, 3.1, and 4.8
Informed Consent > Special Circumstances/Emergencies
Last content review/update: August 18, 2021
Summary

Overview

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 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

Per MWI-22, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant and/or his/her legal representative(s) or guardian(s), or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) must approve the protocol in advance. The participant and/or his/her legal representative(s) or guardian(s) should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

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 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 the 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.

7.0 and 7.4
4.8
Informed Consent > Vulnerable Populations
Last content review/update: August 18, 2021
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 characterizes 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).

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

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.

5.2.1 and 9.2
1.61 and 4.8
Informed Consent > Children/Minors
Last content review/update: August 18, 2021
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.

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

7.0 and 9.2
4.8
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: August 18, 2021
Summary

Overview

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

4.8
Informed Consent > Prisoners
Last content review/update: August 18, 2021
Summary

No relevant provisions.

Informed Consent > Mentally Impaired
Last content review/update: August 18, 2021
Summary

Overview

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

1.61, 3.1, and 4.8
Investigational Products > Definition of Investigational Product
Last content review/update: August 18, 2021
Summary

Overview

As delineated in the D-ImprtRelIMPs and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), 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. Per MWI-43, while there is not yet a formal requirement to implement MWI-22, Malawi is encouraging investigators to follow it.

7
1.33
Investigational Products > Manufacturing & Import
Last content review/update: August 18, 2021
Summary

Overview

According to the PMRAAct, the D-ImprtRelIMPs, and the G-CTARevVacBiol, the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for authorizing the manufacture of investigational products (IPs) in Malawi.

The PMRA 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 permit at the same time that he/she submits the clinical trial application to the PMRA. 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 PMRA requires the manufacturer to provide the following:

  • Evidence of manufacture under conditions compliant with current codes of Good Manufacturing Practice (GMP)
  • 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

G-GMP requires that for IPs, the batch documentation must be retained for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the batch was used.

See MWI-11 for the PMRA’s Good Manufacturing Practice inspection application form.

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

Please note: Malawi is party to the Nagoya Protocol on Access and Benefit-sharing (MWI-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see MWI-35.

Part II (Section 4), Part V (Section 58), and Part X (Section 96)
1, 3, 6, and Annex 1
2.1 and 3.2
2.2.4
3, 5, Checklist of Required Documents (Fees), and Check of Appended Documents (Fees)
2.12 and 5.13
Investigational Products > IMP/IND Quality Requirements
Last content review/update: August 18, 2021
Summary

Overview

In accordance with the G-CTAProcsVacBiol, the Malawi government follows the International Council for Harmonisation’s good clinical practice guidelines and requires the sponsor to provide investigators with an Investigator’s Brochure (IB). Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. MWI-22 provides detailed IB requirements. MWI-22 specifies 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.

Investigator's Brochure Content Requirements

As specified in MWI-22, the IB must include the following sections:

  • Table of Contents
  • Summary
  • Introduction
  • Physical, Chemical, and Pharmaceutical Properties and Formulation
  • Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
  • Summary of Data and Guidance for the Investigator(s)

See MWI-22 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 and Medicines Regulatory Authority (PMRA) 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 PMRA review and approval. He/she should provide information on the acceptable storage temperatures and storage conditions.

Per MWI-22, the sponsor must maintain a CoA to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

5, 6, Annex 1, and Annex 2
Checklist of Required Documents (Appendix 2)
5.13, 5.14, 7, and 8.2
Investigational Products > Labeling & Packaging
Last content review/update: August 18, 2021
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

Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), Malawi is encouraging investigators to follow it. The D-ImprtRelIMPs and MWI-22 state 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.

4
CTA Section 3 Medicines to be used in the trial
5.13
Investigational Products > Product Management
Last content review/update: August 18, 2021
Summary

Overview

In accordance with the G-CTAProcsVacBiol, the Malawi government follows the International Council for Harmonisation’s good clinical practice guidelines and requires the sponsor to provide investigators with an Investigator’s Brochure (IB). Per MWI-43, while there is not yet a formal requirement to implement the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), which provides detailed IB requirements, Malawi is encouraging investigators to follow it. MWI-22 specifies 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 and MWI-22, 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 and Medicines Regulatory Authority (PMRA) and ethics committee (EC) approvals.

The sponsor must ensure the following (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • 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)
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary

Refer to the D-ImprtRelIMPs for detailed sponsor-related IP requirements. (See MWI-40 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.

1, 3, 4, and 5
B (13)
Checklist of Required Documents (Appendix 2)
2.12, 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: August 18, 2021
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, 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.

5.4, 5.5, and 5.6
Specimens > Specimen Import & Export
Last content review/update: August 18, 2021
Summary

Overview

As delineated in the G-CTAProcsVacBiol, the sponsor must obtain approval from the Pharmacy and Medicines Regulatory Authority (PMRA) to import and export human biological specimens into and out of Malawi. The sponsor may apply for an import permit at the same time that he/she submits the clinical trial application to the PMRA.

In cases where investigators are unable to complete all required tests in Malawi, MWI-14, MWI-7, MWI-16, and MWI-28 state that justification must be provided for the importation and exportation of samples. MWI-14, MWI-16, and MWI-7 further indicate that the PMRA, the National Health Sciences Research Committee (NHSRC), and 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
  • Person(s) who will have access to the samples
  • The controlling officer of the samples
  • Ownership of the samples
  • Capacity building (only applicable for MWI-7)

In addition, per MWI-28, 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 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 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 NHSRC has approved a collaborative study between the two (2) parties and the material and information provided protects the participants.

The G-BioSampCompense also confirms that MTAs remain an instrument to be used by a researcher in requesting the approval of an ethics committee (EC) for the transfer of samples for analysis outside of Malawi. According to the G-GenResReqs and MWI-6, COMREC and NHSRC-approved 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. MWI-6 further states that if the sample is to be used beyond five (5) years, an updated authorization must be provided, which will last another five (5) years before it can be renewed. Per G-BioSampCompense, while samples are primarily allowed to be stored as long as they are needed for the initial study, leftover samples are also permitted to be stored as long as needed for a research endeavor. See G-BioSampCompense for additional details regarding EC approval requirements.

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.

(a)(iv) to (ix)
4.12
2, 3, 5, 10, and Checklist of Required Documents (Fees)
3, 6.4, and Annex 1
17
Specimens > Consent for Specimen
Last content review/update: August 18, 2021
Summary

Overview

In accordance with the G-StorExptSpecimens, the G-NHSRC, the G-HlthResConduct, and MWI-6, 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. The G-BioSampCompense also confirms that consent must be obtained.

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 affect their interests.

The G-StorExptSpecimens, says that consent must also be obtained for sample storage and potential future use.

Per G-BioSampCompense, while samples are primarily allowed to be stored as long as they are needed for the initial study, leftover samples are also permitted to be stored as long as needed for a research endeavor. In addition, researchers may use secondary samples with permission of the samples’ custodial entity and if the study receives ethics committee (EC) approval. See G-BioSampCompense additional details regarding EC approval requirements.

Further, the G-GenResReqs, the G-NHSRC, and MWI-6 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-BioSampCompense also confirms that researchers are not allowed to collect human biological samples for undefined research with the intention of storage for unspecified future use. Furthermore, it states that commercialization of human biological samples is prohibited.

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.

(a)
3.4, 4.1, and 4.7
1, 2, 3, 6.4, and Annex 1
12
10.0
Sources > Requirements
(Legislation) Pharmacy and Medicines Regulatory Authority Act, 2019 (PMRAAct) (February 22, 2019)
Parliament
(Legislation) Science and Technology Act, 2003 (No. 16 of 2003) (SciTechAct) (November 7, 2003)
Parliament
(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
(Guidance) Circular No. 01-FIN/2014 Fees Structure (PMPBFees) (March 10, 2014)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Guidance) Circular on Human Biological Samples and Participants Recompense in Research Involving Human Subjects (G-BioSampCompense) (August 22, 2019)
National Commission for Science and Technology
(Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(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
(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
(Guidance) Important Elements in an Informed Consent Form (G-NHSRC-ICF) (Date Unavailable)
National Health Sciences Research Committee
(Guidance) Informed Consent Guidelines (G-COMREC-IC) (Date Unavailable)
College of Medicine Research and Ethics Committee
(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
(Guidance) Pharmacy Guidelines for Investigational Drugs (PharmG-InvestDrugs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Guidance) Pharmacy, Medicines and Poisons Board Good Manufacturing Practices Guidelines (G-GMP) (2013)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Guidance) 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
(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
(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 Health
(Guidance) Serious Adverse Events (SAEs) Reporting Manual for Clinical Trials in Malawi (G-SAEs) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Guidance) Summary of Procedures and Guidelines for the Conduct of Health Research in Malawi (G-HlthResConduct) (Date Unavailable)
National Health Sciences Research Committee
(Guidance) The National Health Sciences Research Committee General Guidelines on Health Research (G-NHSRC) (December 2007)
National Health Sciences Research Committee
Sources > Additional Resources
(Guidance) Clinical Trial Compensation Guidelines (MWI-21) (November 12, 2014)
Association of the British Pharmaceutical Industry
(Guidance) Insurance and Compensation in the Event of Injury in Phase I Clinical Trials (MWI-20) (2nd Edition) (June 2012)
Association of the British Pharmaceutical Industry, BioIndustry Association, and Clinical Contract Research Association
(Document) COMREC Checklist to Accompany New Research Proposals Submitted to the Committee (MWI-1) (Version 3) (September 15, 2019)
College of Medicine Research and Ethics Committee
(Document) GCP Inspection Checklist (MWI-2) (July 2007)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Document) Nagoya Protocol on Access and Benefit-sharing (MWI-3) (2011)
Convention on Biological Diversity, United Nations
(Document) NHSRC Checklist (MWI-4) (Date Unavailable)
National Health Sciences Research Committee
(Document) Press Release of the National Health Sciences Research Committee (NHSRC) on the Health Research Review and Clearance in Malawi (MWI-5) (Date Unavailable)
National Health Sciences Research Committee
(Document) Steps on How to Handle New Protocol Submissions (MWI-51) (Date Unavailable)
National Health Sciences Research Committee
(Document) The Belmont Report: Ethical Principals and Guidelines for the Protection of Human Subjects of Research (MWI-23) (September 30, 1978)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(Document) What is the National Regulatory Requirement and Position on Accessing, Collection, Storage and Use of Human Biological Specimen for Research in Malawi? (MWI-6) (Date Unavailable)
National Commission for Science & Technology
(International Guidance) Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (MWI-41) (Current as of August 17, 2021)
World Health Organization
(International Guidance) Declaration of Helsinki (MWI-42) (October 19, 2013)
World Medical Association
(International Guidance) Directive for Importation and Release of Investigational Medicinal Products (MWI-40) (Date Unavailable)
World Health Organization
(International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (MWI-22) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) International Ethical Guidelines for Biomedical Research Involving Human Subjects (MWI-19) (2002)
Council for International Organizations of Medical Sciences
(Not Available Online) NIAID Communication with National Health Sciences Research Committee (NHSRC) (July 2021) (MWI-55)
(Not Available Online) NIAID Communication with Pharmacy, Medicines, and Poisons Board (PMPB) (July 2019) (MWI-43)
(Webpage) COMREC - About Us (MWI-25) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) COMREC - Contact Us (MWI-26) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) COMREC - Downloads (MWI-27) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) COMREC - FAQs (MWI-28) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) Country Profile: Malawi (MWI-35) (Current as of August 17, 2021)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(Webpage) Health Research Web - Malawi (MWI-39) (Current as of August 17, 2021)
Health Research Web
(Webpage) National Commission for Science and Technology - About NCST (MWI-37) (Current as of August 17, 2021)
National Commission for Science and Technology
(Webpage) National Commission for Science and Technology - Board Composition (MWI-38) (Current as of August 17, 2021)
National Commission for Science and Technology
(Webpage) Pharmacy and Medicines Regulatory Authority - Contact PMRA (MWI-46) (Current as of August 17, 2021)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Webpage) Pharmacy and Medicines Regulatory Authority - Registration (MWI-45) (Current as of August 17, 2021)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Webpage) Pharmacy and Medicines Regulatory Authority – About PMRA (MWI-47) (Current as of August 17, 2021)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Webpage) Pharmacy and Medicines Regulatory Authority – Registration and Regulation of Clinical Trials (MWI-50) (Current as of August 17, 2021)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Webpage) Pharmacy and Medicines Regulatory Authority – The Board of Directors (MWI-49) (Current as of August 17, 2021)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Webpage) Proposal Review System for the NHSRC (MWI-48) (Current as of August 17, 2021)
National Health Sciences Research Committee
(Webpage) The Different Roles Played by the COMREC and the COMREC Secretariat (MWI-29) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) The Relationship between COMREC and NHSRC (MWI-30) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
(Webpage) What Sort of Proposals COMREC Handles? (MWI-31) (Current as of August 17, 2021)
College of Medicine Research and Ethics Committee
Sources > Forms
(Form) Application for Authorization to Conduct a Clinical Trial (Form CT 8) (MWI-9) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Form) Application Form: Current Good Manufacturing Practice Inspection (MWI-11) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority, Ministry of Health
(Form) Application to Conduct Health Research in Malawi (Form 101) (MWI-15) (Date Unavailable)
National Health Sciences Research Committee
(Form) COMREC Material Transfer Agreement Form on Shipping of Samples (MWI-7) (Version 1) (Date Unavailable)
College of Medicine Research and Ethics Committee
(Form) COMREC Progress Report Form (MWI-8) (Date Unavailable)
College of Medicine Research and Ethics Committee
(Form) COMREC Request for Amendment/Modification (MWI-44) (Version 1) (Effective November 25, 2007)
College of Medicine Research and Ethics Committee
(Form) Consent of Person Who Will Participate in a Clinical Trial (Form CT 9) (MWI-13) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Form) Indemnity Form for Conducting Clinical Trials (Form CT 10) (MWI-18) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Form) NHSRC Application for Continuing Review (Form 11-01) (MWI-53) (Date Unavailable)
National Health Sciences Research Committee
(Form) NHSRC Material Transfer Agreement Form (MWI-16) (Date Unavailable)
National Health Sciences Research Committee
(Form) NHSRC Protocol Termination Notification (Form 14-01) (MWI-17) (Date Unavailable)
National Health Sciences Research Committee
(Form) NHSRC Request for Amendment/Modification (Form 10-01) (MWI-52) (Date Unavailable)
National Health Sciences Research Committee
(Form) NHSRC Study Report Submission (Form 15-01) (MWI-54) (Date Unavailable)
National Health Sciences Research Committee
(Form) Pharmacy, Medicines, and Poisons Board Material Transfer Agreement Form on Shipping of Samples (Form CT 12) (MWI-14) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
(Form) Serious Adverse Event Form (Form CT 11) (MWI-12) (Date Unavailable)
Pharmacy, Medicines and Poisons Board, Ministry of Health
Sections Country Announcement
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Country Announcement
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Details on the most recent Malawi updates are available here.

COVID-19 Guidance

  • On April 1, 2020, the College of Medicine Research and Ethics Committee (COMREC) released basic guidance on how studies should proceed during the COVID-19 pandemic. The guidance states that studies should maintain their scientific validity while protecting staff and research participants. All suggested changes by studies should be communicated to COMREC in the form of amendments.  
  • On March 30, 2020, COMREC issued guidance indicating that submissions will continue to be processed during the COVID-19 pandemic. It is recommended that submissions be submitted electronically instead of in person at their offices to ensure safety. In the event of a lockdown, researchers should notify COMREC of measures that will be taken for all active studies to ensure participants’ rights, safety, and well-being are protected. These measures must be approved by COMREC prior to implementation.
  • African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)

 

This message was reviewed on November 11, 2021
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