Malawi Profile Updated

August 25, 2023
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The Malawi profile in ClinRegs has been reviewed and updated as follows:

  • Updated Pharmacy and Medicines Regulatory Authority (PMRA) serious adverse event guidance, clarifying reporting timeline requirements (See Safety Reporting) 
  • New PMRA forms for declaration of intent, declarations by investigators, and power of attorney (See Submission Process and Submission Content) 
  • Updated versions of the National Health Sciences Research Committee (NHSRC) application form, continuing review form, and checklist (See Scope of Review, Submission Process, and Submission Content) 
  • New NHSRC serious adverse event reporting form (See Safety Reporting) 
  • Information related to the College of Medicine Research and Ethics Committee (COMREC)’s National Research Information Management System (NRIMS) for protocol submission (See Submission Process) 
  • Links to various updated PMRA and NHSRC guidance and forms which did not result in changes to summary content 

Sources Added During this Update:

(Document) National Research Information Management System (NRIMS): Step-By-Step Guide to Make Your Protocol Submissions for Approval to Conduct Research in Malawi (MWI-10) (Date Unavailable)
College of Medicine Research and Ethics Committee, Kamuzu University of Health Sciences

(Form) Declaration of Intent, Signed by Contact Person & National Principal Investigator (MWI-31) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Form) Format for Declarations by Investigators (MWI-32) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Form) NHSRC Serious Adverse Event Reporting Form (MWI-2) (Date Unavailable)
National Health Sciences Research Committee

(Form) Power of Attorney (MWI-33) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(International Guidance) Good Clinical Laboratory Practice (‎GCLP)‎ (MWI-30) (2009)
World Health Organization

(Not Available Online) NIAID Communication with College of Medicine Research and Ethics Committee (COMREC) (July 2023) (MWI-25)

(Not Available Online) NIAID Communication with Pharmacy and Medicines Regulatory Authority (PMRA) (August 2023) (MWI-34)

(Webpage) National Commission for Science and Technology – Research Clearance (MWI-26) (Current as of August 25, 2023)
National Commission for Science and Technology

(Webpage) National Research Information Management System (NRIMS) (MWI-19) (Current as of August 25, 2023)

(Webpage) Pharmacy and Medicines Regulatory Authority – Frequently Asked Questions (MWI-29) (Current as of August 29, 2023)
Pharmacy and Medicines Regulatory Authority

Sources Revised During this Update:

(Guidance) Directive for Importation and Release of Investigational Medicinal Products (D-ImprtRelIMPs) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Guidance) Important Elements in an Informed Consent Form (G-NHSRC-ICF) (Date Unavailable)
National Health Sciences Research Committee

(Guidance) Pharmacy Guidelines for Investigational Drugs and Pharmacy Plan (PharmG-InvestDrugs) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Guidance) Serious Adverse Events (SAEs) Reporting Manual for Clinical Trials in Malawi (G-SAEs-PMRA) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Document) NHSRC Checklist (MWI-4) (Date Unavailable)
National Health Sciences Research Committee

(Document) Submission of a Clinical Trial Application (CTA) to Pharmacy and Medicines Regulatory Authority (PMRA) – Checklist (MWI-60) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Form) Application for Authorization to Conduct a Clinical Trial (Form CT 8) (MWI-9) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Form) Application to Conduct Health Research in Malawi (Form 101) (MWI-15) (Date Unavailable)
National Health Sciences Research Committee

(Form) Indemnity Form for Conducting Clinical Trials (Form CT 10) (MWI-18) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(Form) Material Transfer Agreement Form on Shipping of Clinical Trial Samples (Form CT 11) (MWI-14) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

(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 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) Serious Adverse Event Form (MWI-12) (Date Unavailable)
Pharmacy and Medicines Regulatory Authority

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