Medicines Registration 

This section provides the requirements for the initial registration of medicines (marketing authorization) in the Intergovernmental Authority on Development (IGAD) Region. This section provides requirements that have been harmonized in medicines registration so as to ensure the efficacy, quality and safety of medicines to be available to member states in IGAD.
Please note that national requirements shall be established in keeping with each member state legislation, and whenever pertinent, appropriate amendments will be made in order to adhere as much as possible to harmonized requirements. The advantage of medicine registration includes;
• Standardization: Requirements and Format of regulatory data 
• Reduction: Cost and Time for regulators and industry. No duplication of work. 
• Improved Regulatory Capacity: More efficient and collaborative use of resources
• Faster access of medicines to patients at lower cost. 
• QMS Enabler for Quality Management Systems: Consistency and Transparency Facilitate and Promote trade in medicines
• Improved compliance and quality of data submitted
• Contribute towards African Medicine Regulatory Harmonization Initiative. 

Good Manufacturing Practice

As part of regional cooperation on health, Intergovernmental Authority on Development (IGAD) has initiated the process of harmonizing the regulation of the manufacture, import, trade, sale and export of all medicines through the legal mandate of the IGAD and the existing National Medicines Regulatory Authorities (NMRAs) in each of Member States. 

The purpose of the IGAD-MRH Project is to harmonize medicine registration in the IGAD Member States to increase the rapid availability of good quality, safe and efficacious medicines within the IGAD region. Each IGAD-NMRA requires Good Manufacturing Practice (GMP) inspections for sites where medicines are being manufactured. 
The overall objective harmonization of GMP inspection is to develop and implement a system for carrying out GMP inspections for purposes of registration of medicines in the IGAD region and contribute in improving the availability of safe, quality and effective medicines. The Technical capacities for GMP inspection of IGAD-NMRAs will also be increased. 
The following tasks will be undertaken in the IGAD-MRH program:
• Practical and technical knowledge of NMRA inspectors in GMP.
• Continuous training of regulatory staff of IGAD-NMRAs.
• Development of technical requirements for GMP for the IGAD-NMRAs
• Establishment of a framework for joint inspections of medicine manufacturing sites and to ensure that these assessments are integrated into national decision-making processes
• Promotion of exchange of information on GMP among IGAD-NMRAs and other international organizations. 

Quality Management Systems

The goal of Harmonization of Quality Management System (QMS) in Intergovernmental Authority on Development (IGAD) National Medicines Regulatory Authorities (NMRAs) is to have harmonized and functioning QMS within the NMRAs in accordance with national and internationally recognized standards.
IGAD-NMRAs will be required to develop QMS requirements including drafting Quality Manuals and Standard Operating Procedures. 
The Overall Objective is to implement agreed common QMS requirements for regulation of medicines in IGAD-NMRAs.
There will be development of the following; 
• Common QMS requirements for application for registration of medicines. 
• Quality manuals and Standard Operating Procedures (SOPs)
• Roadmap to implementation of QMS based on National or International recognized standards to be adopted by IGAD-NMRA.