Stakeholders

Names
Circular on public consultation and call for comments on regulatory documents
Guidelines for Good Storage and Distribution Practices of Medical Products_ED 11.03.2024
Regulations Governing Licensing of public and private manufacturers, distributors,wholesalers,retailers of medical products_ED 11.03.2024
Regulations_Governing_Good_Storage_and_Good_Distribution_Practices_of_Medical_products -Ed 11.3.2024
Circular for call for comments on revised GMP guideline
New GMP guidelines draft 15 Jan 2024
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
Guidance on good practices for desk assessment for compliance with GMP and GLP for marketing authorization of products
Guidelines for Good Manufacturing Practice for Finished Pharmaceutical Products - Part 1
Guidelines on Good Manufacturing Practice for Active Pharmaceutical Products - Part 2
Regulations Governing Licensing of public and private M, D, W, R of Medical Products
Guidelines on licensing of public and private M, D,W,R of medical products
Circular on Call for Comments on Reviewed Clinical Trial Technical Documents
Comment Form- Clinical trial Oversight Documents
V02-Regulation governing the conduct and Inspection of Clinical Trials in Rwanda Draft for comment till-3-03-2023
Ver01-Guidelines on GCP Inspections of Clinical Trials in Rwanda Draft for comment till-3-03-2023
Ver02-Guidelines on clinical Trial Applications in Rwanda Draft for comment till-3-03-2023
Ver 01-Guidelines on GCP in Rwanda-Draft for comment till 3-03-2023
Ver01-Guidelines on Review of Clinical Trial Applications-Draft for comment till 3-03-2023
Final Guidelines on submission of documentation for registration of IVDDs
FINAL REVISION MEDICAL DEVICES GUIDELINES
GMP GUIDLINE FOR FOOD 04_AUGUST_2022
GMP Regulation semi final 04TH_AUGUST_2022
GMP Virtual and waiver Template for Guidelines 03_08_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
GUIDELINES FOR LICENSING-8_AUGUST_2022
GUIDELINES FOR REGISTRATION OF MEDICAL PRODUCTS FOR UNMET MEDICAL NEEDS 26-08-2022
GUIDELINES FOR THE CANCELLATION SUSPENSION OF MARKETING AUTHORISATION FOR MEDICAL PRODUCTS
Guidelines on GCP in Rwanda
Guidelines on Inspections of Clinical Trials in Rwanda Validation 15_06_2021
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
Guidelines on Review of Clinical Trial Application DRAFT Validation 5_10_2021
REGULATION GOVERNING PMS OF REGULATED PRODUCTS
REGULATIONS GOVERNING CONTROL OF IMPORT-EXPORT OF FOOD PRODUCTS Draft for validation
REGULATIONS GOVERNING MANUFACTURING PRACTICES OF MEDICAL PRODUCTS
REGULATIONS LICENSING 10_AUGUST_2022
Final Guidelines for Submission of Documentation for Registration of Laboratory Chemicals
RwandaFDA draft Business Plan for Financial Sustainability 1st_April_2022
Guidelines on licensing of public and private M, D,W,R of medical products_ Stakeholders inputs
Guidelines on Good Manufacturing Practice for Active Pharmaceutical Products - Part 2
Regulations Governing Licensing of public and private M, D, W, R of Medical Products_STAKEHOLDERS (1)
Guidelines for Good Manufacturing Practice for Finished Pharmaceutical Products - Part 1
REGULATIONS GOVERNING MANUFACTURING PRACTICES OF MEDICAL PRODUCTS- ED JANUARY 2023
Guidance on good practices for desk assessment for compliance with GMP and GLP for marketing authorisation of products (1)
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 for registration of Human Biological Products
DRAFT GUIDELINES FOR VARIATION OF REGISTERED PHARMACEUTICAL PRODUCTS
Draft Guidelines on submission of Documentation for Registration of Medical Devices
Draft-Guidelines for Registration of Biosimilar Products
Format for providing comment on document under development process
Draft Guidelines for Registration of Pharmaceutical Products