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TRAINING ON MEDICINES REGISTRATION IN IGAD REGION CLOSES WITH SUCCESS

24-08-2018, Entebbe (Uganda): After five days of informative presentations, active participation and intensive group works, the Intergovernmental Authority on Development (IGAD) and the World Health Organisation (WHO) today closed the training on Dossier Assessment of Priority Medicines for the purpose of a harmonised medicines registration in the IGAD region.

 

 

 

 

 

This training was conducted within the framework of the IGAD Medicines Regulatory Harmonization (MRH) Initiative that is also supported by the World Bank.

Dr Fatuma Adan, Senior Regional program Coordinator at the IGAD Health and Social Development Division, appreciated the good quality of the presentations by the facilitators and the high level of engagement by the participating IGAD Member States’ Experts of National Medicines Regulatory Authorities (NMRAs).
 As participants were given the opportunity to reflect on the training sessions overall,


 Dr. Maper Dut Ador Weak, Pharmacist and Senior Inspector in Inspection & Surveillance at the
South Sudan Drug & Food Control Authority (DFCA), expressed the desire and need for a follow-up training in order to deepen the knowledge gained. That would be very much justified for and would help countries with very limited mechanisms of medicines registration to set up or strengthen registration facilities.


 Dr Maper was joined by Dr. Yusuf Omar Mohamed, Chief Pharmacist and Head of NMRA-Somalia Ministry of Health and Human Services, who also pleaded for a community of practice among the participants that would allow information and knowledge sharing among member States and with the other stakeholders.


 Dr Abraham Gebregiorgis, Geneva-based Technical Officer of the WHO, duly took note of the calls and expressed WHO willingness to support further capacity building within the resource limitations to the IGAD Medicines Regulations Harmonisation initiative.

IGAD AND WHO TRAIN FOR HARMONISATION OF MEDICINES REGISTRATION

20-08-2018, Entebbe (Uganda): The Intergovernmental Authority on Development (IGAD), with support from the World Health Organisation (WHO), this morning launched a five-day Hands-on Training and Dossier Assessment of Priority Medicines for IGAD Member States’ Experts of National Medicines Regulatory Authorities (NMRAs) in Entebbe.

This training, which is conducted within the framework of the IGAD Medicines Regulatory Harmonization (MRH) Initiative, is a capacity building exercise and dossier assessment of selected priority medicines in order to determine avenues for collaboration between IGAD Secretariat and member States NMRAs. It is also aimed at building capacity in the area of medicines registration and on how to review an application for marketing authorization for priority medicines.
 More specifically, participants will be trained:

    • on review of applications for marketing authorization submitted using the Common Technical Document developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-CTD);
    • on abbreviated risk based review procedures that will accelerate registration of products registered by stringent regulatory authorities and prequalified by World Health Organization; and
    • to brief on and identify issues with regard to harmonization of medicine registration in the region.

     In her opening remarks, Dr Fatuma Adan - Senior Regional program Coordinator at the IGAD Health and Social Development Division, noted that it was “crucial for regional health systems and policies be harmonized and adopted by national governments in order to protect the region’s population”.
     She recalled that “IGAD Regional MRH Initiative Proposal was endorsed by Member States in August 2017 and by the 10th Health Ministerial meeting in March 2018”. She tanked “WHO for their continued support in the region as Technical lead partner in global public health issues”.
     Dr Abraham Gebregiorgis, Geneva-based Technical Officer of the WHO, underlined the critical aspect of the training in the implementation process of the IGAD Medicines Regulation & Harmonisation (MRH) programme. “On the one hand, it will build the technical capacity of the National Medicines Authorities, and on the other hand, it will be laying the foundation of the initiation of the IGAD MRH joint assessment activities”, he added.
     Dr Abraham expressed his hope to see participants share gained skills and knowledge with respective colleagues at home and improve “efficiency and effectiveness in assessing dossier and also contribute in the regional joint activities”.
     The mandate of National Medicines Regulatory Authorities (NRAs) is to protect the health of the public by allowing access to essential quality, safe and efficacious medicines. Dossier review and approval of essential medicines is a key factor to fulfillment of this mandate.
    Despite this, most NMRAs are still faced with chronic shortage of human and technical resources, mainly due to budgetary constraints. There is need for member states to collaborate in dossier review so as to better utilize the scarce technical and financial resources available in an effort to improving systems for registration of medicines in the region.

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