Malawi Profile Updated
The Malawi profile in ClinRegs has been reviewed and updated with the following information:
- Data protection requirements related to the processing of personal data and the rights of data subjects (See Personal Data Protection)
- Additional details and requirements related to the import of investigational products from a November 2023 Pharmacy and Medicines Regulatory Authority (PMRA) guidance (See Timeline of Review, Initiation, Agreements & Registration, Manufacturing & Import, Labeling, and Product Management)
- Responsibilities of the National Commission for Science and Technology (NCST) as described in a July 2024 NCST order (See Regulatory Authority)
- Updated National Health Sciences Research Committee (NHSRC) forms and proposal checklist, which underwent minor revisions (See Forms)
Sources Added During this Update:
(Legislation) Data Protection Act, 2024 (No. 3 of 2024) (G-DataPrtct-MWI) (February 2, 2024)
Parliament
(Guidance) Guidance on Importation and Exportation of Medicinal Products and Active Pharmaceutical Ingredients (G-ImpExpMP) (Effective November 2023)
Pharmacy and Medicines Regulatory Authority
(Order) Science and Technology (Prescribed Activities) Order, 2024 (SciTechOrder) (July 5, 2024)
National Commission for Science and Technology
(Webpage) Pharmacy and Medicines Regulatory Authority – Technical Committees (MWI-36) (Current as of August 29, 2024)
Pharmacy and Medicines Regulatory Authority
Sources Revised During this Update:
(Document) Research Information Management System (RIMS): 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) Application to Conduct Health Research in Malawi (Form 101) (MWI-15) (Date Unavailable)
National Health Sciences Research Committee
(Form) NHSRC Checklist (MWI-4) (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 Serious Adverse Event Reporting Form (MWI-2) (Date Unavailable)
National Health Sciences Research Committee