- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > drug registration
- Palabras clave > harmonization of medicines regulation
- Palabras clave > International Conference on Harmonisation (ICH)
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > registration of medicinal products
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory institutional capacity
(2014; 312 pages)
The “EAC Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products’ First Edition, April 2014’ is an EAC publication which sets out procedures and requirements for the implementation of Pharmaceutical Products Registration through established CTD within EAC NMRAs. This Compendium contains Five Modules:
Module 1: the East African Community Medicinal 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 the East African region.
The East African Community Medicines Regulatory Harmonization (EAC-MRH) programme was established to help Partner States build effective medicines regulation procedures through harmonization and regulatory capacity building. Most of the EAC Partner States have challenges in assuring the safety, efficacy and quality of medicines circulating in their markets due to a number of factors including limited human and infrastructural capacity to regulate, varying standards of regulations, long procedures to introduce new medicines in the market.
Adherence to the guidelines by the manufacturers/applicants will facilitate timely assessments and approvals of medicinal product dossiers by the regulatory authorities for pre-marketing evaluation, marketing authorization/registration and post-marketing review.