Stakeholders

Names
Regulations Governing the Marketing of Breast Milk Substitutes-September 17-2025
Format-for-providing-comment-on-document-under-development-process
Guidelines on submission of Documentation for Registration of Public Health Antiseptic and Disinfectant Products
Guidelines on Submission of Documentation for Registration of Public Health Laboratory Chemicals
Guidelines on Submission of Documentation for Registration of Vector Control Products
Guidelines on Submission of Documentation for Variation of Registered Cosmetics, Vector Control and Public Health Laboratory Chemicals
Guidelines on Submission of Documentation for Registration of Cosmetic Products
GUIDELINES FOR GOOD CLINICAL PRACTICES IN RWANDA
GUIDELINES FOR GCP INSPECTION OF CLINICAL TRIALS IN RWANDA
SERIOUS ADVERSE EVENTS (SAE) REPORTING FORM
REGULATIONS GOVERNING THE CONDUCT AND INSPECTION OF CLINICAL TRIALS IN RWANDA
JOINT DECLARATION FOR SUFFICIENT FUNDS TEMPLATE
INVESTIGATIONAL PRODUCT QUALITY OVERALL SUMMARY TEMPLATE
GUIDELINES FOR REVIEW AND APPROVAL OF CLINICAL TRIALS
GUIDELINES FOR CLINICAL TRIAL APPLICATIONS IN RWANDA
DRAFT_GUIDELINES FOR MONITORING AND REPORTING CLINICAL TRIAL SAFETY DATA IN RWANDA
DRAFT_GUIDANCE - THERAPEUTIC OR VACCINE CLINICAL TRIAL APPLICATION EVALUATION DURING PUBLIC HEALTH EMERGENCY
DECLARATION BY PI OR CO-PI TEMPLATE
CLINICAL TRIAL PROTOCOL FORMAT
CLINICAL TRIAL CAUSALITY ASSESSMENT REPORT
CLINICAL TRIAL APPLICATION FORM
Draft Guideline For Registration Of Innovative Medical Products
Format-for-providing-comment-on-document-under-development-process
Format for providing comment on document under development process
02-06-2025_Regulations governing Food Fortification version 2
DD-VMDR-GDL-003 Ver 2 Guidelines for Registration of Veterinary Immunological Products
DD-VMDR-GDL-OO1 Ver 2 Guidelines for Registration of Veterinary Pharmaceutical Products
DD-VMDR-GDL-004 Ver 2 Guidelines for Registration of Veterinary Biological Product
Regulations for Processed food products
Prohibition of dispensing specified medicines without medical prescription
prohibition to sell medical products to unauthorized retailers
Temporary suspension of opening new Retail Pharmacies
ADDENDUM TO THE LICENSING REGULATION
Regulatory Guidance on the conduct of Joint enforcement inspections on food and beverage products 30-07-2024_EN
Format for providing comment on document under development process
Guidelines for Registration of Food Supplements-Final Draft_26-06-2024
Guidelines for Registration of Processed Food-Final Draft_26-06-2024
Requirements of Test Parameters for Processed Food Registration
Circular on public consultation and call for comments on regulatory documents
STAKEHOLDERS NOTICE
Circular on public consultation and call for comments on veterinary products regulatory documents
REGULATIONS GOVERNING MANUFACTURING PRACTICES OF MEDICAL PRODUCTS- ED JANUARY 2023
Circular on Call for Comments on Reviewed Clinical Trial Technical Documents
Final Guidelines on submission of documentation for registration of IVDDs
GMP GUIDLINE FOR FOOD 04_AUGUST_2022
GUIDELINES FOR IMPORTATION AND EXPORTATION OF COSMETIC PRODUCTS Draft for validation
GUIDELINES FOR IMPORTATION AND EXPORTATION OF FOOD PRODUCTS Draft for validation
GUIDELINES FOR IMPORTATION AND EXPORTATION OF PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES Draft for validation October_2022
GUIDELINES FOR IMPORTATION AND EXPORTATION OF TOBACCO AND TOBACCO PRODUCTS Draft for validation
Internally validated Guidelines on submission for documentation of registration of cleaning chemicals
Regulation Governing control of import export of pharmaceutical products medical devices draft for validation October_2022
REGULATIONS GOVERNING CONTROL OF IMPORT-EXPORT OF FOOD PRODUCTS Draft for validation
Final Guidelines for Submission of Documentation for Registration of Laboratory Chemicals
RwandaFDA draft Business Plan for Financial Sustainability 1st_April_2022
Draft-Guidelines for Conducting Veterinary Pesticides Field Trials
Draft-Guidelines for the Registration of Veterinary Pesticides
Draft-Guidelines on Specific Efficacy Trials Requirements for Ectoparasiticides on Cattle in the EAC.
Draft-Veterinary pesticide Good Manufacturing Practice inspection guidelines (Annex)
Draft Guidelines on submission of Documentation for Registration of Medical Devices
Format for providing comment on document under development process
23-10-2024 _ Regulations Governing Regulatory Inspections for Processed food products and related products
23-10-2024 Guidelines for Regulatory inspection for processed food products and related products
Guidelines for Post Market Surveillance
DRAFT-REGULATIONS GOVERNING THE CONTROL OF PROCESSED FOOD PRODUCTS
Guidelines Governing LR_Final draft
Regulations Governing LR_Final version