- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > harmonization - medicines registration
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > registration - Collaborative Registration Procedure (CRP)
- Palabras clave > registration of medicinal products
- Palabras clave > registration of pharmaceuticals
- Palabras clave > enregistrement des médicaments
(2014; 436 pages)
The "MOH Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products" First Edition, November 2014 is an MOH publication which sets out procedures and requirements for the implementation of Pharmaceutical Products Registration.
This Guideline contains Five Modules:
Module 1: MOH Pharmaceutical Products Registration Administrative Requirements;
Module 2: the Quality Overall Summaries (QOS),
Module 3: the Quality Requirements for the Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP);
Module 4: Pre-Clinical data Requirements
Module 5: Clinical data Requirements.
The general objective of the Common Technical Document (CTD) guidelines is to provide harmonized medicines registration procedures using CTD in order to improve access to essential medicines for prevention and treatment of priority disease conditions in Rwanda. Adherence to the guidelines by the manufacturers/applicants will facilitate timely assessments and approvals of medicinal product dossiers by MOH for pre-marketing evaluation, marketing authorization/registration and post-marketing review.