IGAD TO DEVELOP REGIONAL MEDICINES ASSESSMENT, REGISTRATION GUIDELINES

ENTEBBE, The Inter-Governmental Authority on Development (IGAD), an eight-nation Horn of Africa grouping, has held the inaugural meeting of its Technical Experts Working Group on Medicines Assessment and Registration, in Entebbe, Uganda, under the leadership of IGAD Programme Manager of Health and Social Development, with representatives from the World Bank, the World Health Organization (WHO), Ethiopia, and Uganda in attendance.

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 a pilot joint review of essential priority medicines, and determine avenues for collaboration between IGAD and the respective National Medicine Regulatory Authority (NMRA).

The IGAD Programme Manager of Health & Social Development, Fathia Alwan, stressed the need for a strong and fully functional National Medicine Regulatory Authority (NMRA), according to a statement posted on the IGAD website.

She called for the establishment of such an institution where it is non-existent yet in order to fight the circulation of sub-standard, spurious, falsely labeled, falsified and counterfeit (SSFFC) medicine products within the IGAD member states which a result of 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.

The head of the Ethiopian Food, Medicine, and Healthcare Administration and Control Authority, Abdulkader Woryei Fato, who chaired the meeting, reminded that the initiative emanated from the first IGAD Scientific Conference on Health held in December 2014 in Addis Ababa.

Abdulkader urged the participants to work on the outcomes which will lead to the next step. A reference list of registered products will be uploaded into an IGAD web portal whereby the list will serve as a point of reference for member states that do not have regulatory authority.

Draft Terms of Reference for the IGAD-Technical Working Group (TWG) for Medicine Registration, a draft project activity or work plan, and draft quality guidelines for review to nominated officials from IGAD, are among the other outcomes that are expected.

Source: NAM NEWS NETWORK

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