Guidance on the Establishment of Scientific Review Committees in Rwanda FDA Aug.2021
Guidelines for Appeals againts Rwanda FDA Regulatory Decisions July, 2021_v01
GUIDELINES FOR LICENSING TO MANUFACTURE, TO OPERATE AS A WHOLESALE AND RETAIL SELLER OF MEDICAL PRODUCTS
GUIDELINES ON GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICAL PRODUCTS
Guidelines for control of promotion advertisement and marketing
Guidelines on Review and Approval of Clinical Trials Amended, 2021
Guidelines on Good clinical Practices (GCP) in Rwanda Amended, 2021
Guidelines on GCP Inspections of Clinical Trials in Rwanda
Guidance on application for biopharmaceutics classification system based biowaivers
Guidance on stability testing for APIs and FPPs
GUIDANCE ON PRODUCT QUALITY REVIEW (PQR) REQUIREMENTS FOR GENERIC HUMAN MEDICINAL PRODUCTS
GUIDANCE ON REGISTRATION OF FIXED DOSE COMBINATION FOR HUMAN MEDICINAL PRODUCTS
GUIDANCE ON NAMING OF HUMAN MEDICINAL PRODUCTS
Guidance on Procedural Aspects for Applications for Marketing Authorization
GUIDELINES ON RELIANCE FOR REGULATORY DECISION
RWANDA FDA COMMON GLOSSARY OF TERMS USED IN MEDICINES REGISTRATION
RWANDA FDA GUIDANCE ON THERAPEUTIC EQUIVALENCE REQUIREMENT
GUIDELINES FOR DONATION OF MEDICAL PRODUCTS
GUIDANCES ON FORMAT AND CONTENT OF SmPC FOR HUMAN MEDICINAL PRODUCTS
Guidance on Format and Content of patient information Leaflet for Human Medicinal Products
GUIDANCE ON FORMAT AND CONTENT OF LABELS FOR HUMAN MEDICINAL PRODUCTS
Guidelines for Good review practices
Guidelines for Renewal of Registered Human and Veterinary medicinal Products
Guidelines for Authorization for Emergency Use for Medicinal Products Medical devices and IVDs
Guidelines for Adverse Event Following Immunization
Guidelines on Good Manufacturing Practices on Pharmaceutical Products Annexes
Guidelines for Good Distribution Practices of Medical Products
Guidance on Manufacturing and Use of Barrier Masks Version-2
Guidelines for Regsitration of Households and pesticides
Rwanda FDA Guidelines of Specifications of coverall Protective Clothing
Guidelines for licensing to Manufacture, operate as wholesale and retail seller of medical products
Guidelines for Registration of Similar Biotherapeutic Products
Guidelines for Registration of Medical Devices
Guidelines on Clinical Trial Applications in Rwanda Amended,2021
Guidelines on Eye protectors
Guidelines on Good Manufacturing Practice for Finished Pharmaceutical Products
Guidelines on Recall Treatment and Disposal of Unfit Pharmaceutical Products
Guidelines on Requirements and Specifications of Ventilators
Guidelines on submission of documentation for registration of Human Biological Products
Rwanda FDA Guidelines on Abridged procedures for pharmaceutical products Assessment
Rwanda FDA Guidelines on Safety and Vigilance of Medical Products and Health Technologies
guidelines for importation and exportation of food
RWANDA FDA GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF ANTISEPTICS AND DISINFECTANT
guidelines for evaluation of food supplement
guidelines for good manufacturing practices of food
guideline for application and registration of processed food
guidelines for investigation and control of food born disease
guidelines for registration and lincensing of food premises
Rwanda FDA guidelines on preparation of alcohol based hand sanitizers
Guideline on submission of documentation for Registration of medicated cosmetic Products
Guidelines on submission of documentation for registration of human medicinal products
RWANDA FDA GUIDELINES FOR VARIATION OF REGISTERED HUMAN MEDICINAL PRODUCTS
Guideline for Post marketing surveillance guidelines
Guidelines for Introducting a locally manufactured new human medicinal products to the Rwandan Market
Veterinary guidelines for registration
GUIDELINES FOR IMPORTATION AND EXPORTATION OF PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES
Guidelines on good practice for desk assessment
guideline for evaluation of food supplement
guidelines for investigation and control food born disease
GUIDELINES GOOD DISTRIBUTION PRACTICE OF MEDICAL PRODUCTS

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