24-04-2017, Entebbe (Uganda): The Intergovernmental Authority on Development (IGAD) this morning launched the First Meeting of the Technical Experts Working Group on Medicines Assessment and Registration in Entebbe under the leadership of the Programme Manager of the Health & Social Development, Ms Fathia Alwan, with representatives from the World Bank (WB), the World Health Organisation (WHO), Ethiopia, and Uganda at the high table.
This five-day meeting is bringing together Experts and officials from IGAD Member States in charge of their respective National Medicine Regulatory Authority (NMRA) whose mandate is to guarantee populations’ access to essential quality, safe, and efficacious medicines.
The long term goal of the Working Group is to develop a draft policy towards harmonization of registration and evaluation of medicines, while the overall objective of this First Meeting of Experts is to develop an IGAD reference list of registered products, conduct pilot joint review of essential priority medicines, and determine avenues for collaboration between IGAD-NMRAs.
In her opening remarks, Ms Fathia Alwan, speaking on behalf of the Executive Secretary of IGAD , noted the need for a strong and fully functional National Medicine Regulatory Authority (NMRA). Ms Alwan called for the establishment of such an institution where it is non-existent yet in order to fight circulation of “Substandard, Spurious, Falsely labeled, Falsified and Counterfeit (SSFFC) medicine products within the IGAD member states” which “is due to limited post-marketing surveillance systems, lack of databases, and lack of collaborative information sharing systems among NMRAs”. “Strengthening the regulatory system directly improves the quality of life of the public through ensuring access to medicines that are safe, effective and of assured good quality”, she added.
Mr. Apollo Muhairwe, Senior Operations Officer at the World Bank Kampala Office, congratulated IGAD for establishing the Technical Working Group on Medicines Assessment and Regulation. “We are pleased with this initiative owned by IGAD and the process in which it is being carried out by IGAD with financial and technical support from the African Medicines Regulatory Harmonization partners. The World Bank is a partner you can count on”, he said in substance. He also urged the participants to the meeting to come up with tangible outcomes.
“The World Health Organisation (WHO) has been partnering with IGAD since 2014 from the inception of the need for harmonization of medicine regulation and capacity building of medicine regulatory authorities”, Mr. Abraham Gebregiorgis of the WHO Geneva Office said. He continued that “WHO will continue closely working with IGAD to ensure that the MRH program is organized and implemented on the basis of the principles, objectives and processes of the African Medicine Regulatory Harmonization (AMRH) program”.
Mr. Abdulkader Woryei Fato of the Ethiopian Food, Medicine, and Healthcare Administration and Control Authority, in his capacity as Chair of the meeting, reminded the audience that the initiative emanates from the First IGAD Scientific Conference on Health held on December 2014 in Addis Ababa, Ethiopia. He urged the participants to work on the outcomes that will lead to the next step before leaving the floor to Mr. Andrew Okello Okonye of the Ugandan National Drug Authority and Guest of Honor, to officially open the meeting.
After conducting this meeting, a reference list of registered products will be uploaded into an IGAD web portal that is being developed simultaneously. This list will serve as a point of reference for Member States that do not have regulatory authority. The other expected outcomes include a draft Terms of Reference for the IGAD-Technical Working Group (TWG) for Medicine Registration, a draft project activities/work plan, and draft quality guidelines for review to nominated officials from IGAD.###