Human medecine Guidances

Guidance
Names
Guidance for Product Quality Review (PQR) requirements for generic medicinal products
Guidance on Competency Requirements and Training Needs for Rwanda FDA Medicinal Products Assessors
Guidance on Format and Content of Labels for human medicinal products
Guidance on Format and Content of Patient Information Leaflets for human medicinal Products
Guidance on Format and Content of Summary of Product Characteristics for human medicinal products
Guidance on Naming of Human Medicinal Products
Guidance on procedural aspects for application for marketing authorization
Guidance on registration of fixed dose combination for human medicinal products
Guidance on therapeutic equivalence requirements
Guidance for Assessment of Human Medicinal Products
Guidance on application for biopharmaceutics classification system based biowaivers
Guidance on Stability Testing for Active Pharmaceutical Ingredients and Finished Pharmaceutical Products