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IGAD INITIATES A REGIONAL APPROACH TO MEDICINES QUALITY SURVEILLANCE

 

25 June 2018, Addis Ababa (Ethiopia): Launching a five-day meeting this morning, the Intergovernmental Authority on Development (IGAD) took key steps to strengthening pharmacovigilance and post-marketing surveillance systems for medicines marketed in Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda; with specific attention to cross-border points.

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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. Continue Reading »

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IGAD Medicines Regulation and Harmonization

IGAD MRH Program

The IGAD IMRH Project will promote the harmonization of medicines registration in the region, which is a key contributor to public health and leads to rapid access to good quality, safe and effective medicines for priority diseases This marks the beginning of the implementation phase of the IMRH Programme across IGAD.

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. Continue Reading »

 

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.Continue Reading »

Information Management Systems

The use of management information systems has become necessary for any IGAD member state to facilitate the work procedures and improve efficiency and productivity and improve performance in general.