- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > harmonization of medicines regulation
- Palabras clave > International Conference on Harmonisation (ICH)
- Palabras clave > marketing authorization
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > quality management system (QMS) for NRA/NCL
- Palabras clave > registration of medicinal products
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory information management system
- Palabras clave > regulatory institutional capacity
- Palabras clave > enregistrement des médicaments
(2014; 172 pages)
This Compendium has been developed to provide guidance to EAC Partners States National Medicines Regulatory Authorities to implement Quality Management System (QMS).
The Compendium was compiled by the East African Community (EAC) Technical Working Group (EWG) on QMS. The EWG relied on available International Standards (ISO 9000 series, ISO/IEC 17020 and ISO/IEC 17025), WHO guidelines, and other experiences from other medicine regulatory authorities.
This Compendium contains five parts namely:
- The East African Community Quality Management System Requirement, 2014
- The EAC Guidelines for the implementation of Quality Management System Requirements for the Regulation of Medicines, Cosmetics, Medical Devices and Diagnostics, 2014
- The Model Manual on the Implementation of East African Community Quality Management System Requirements for the Regulation of Medicines, Cosmetics, Medical Devices and Diagnostics, 2014
- The Mandatory Documented Procedures; and
- Code of Conduct for Partner States National Medicines Regulatory Authorities, 2014.