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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.



 

 

Four key outputs aimed at expanding access to quality-assured medicines in IGAD member states are expected by the close of the week:

 

 

 


1.

Establishment of a Regional Expert Working Group on Pharmacovigilance & Post-Marketing Surveillance.


2. Recommendations for a regional cross-border pharmacovigilance system.


3.

Recommendations for implementation of a regional post-marketing surveillance strategy and related guidelines.
4. A regional protocol for studying the prevalence of substandard and falsified medicines at selected IGAD cross-border sites, targeting products used in maternal & child health, family planning, tuberculosis, and HIV & AIDS programs.

Participants in the meeting include representatives from medicines regulatory authorities in IGAD countries as well as technical assistance experts from the Promoting the Quality of Medicines (PQM) program, which is financed by the U.S. Agency for International Development and implemented by the United States Pharmacopeia. IGAD is partnering with the PQM program for technical support in recognition of its global experience in strengthening medicines quality assurance systems.

The meeting is being chaired by Ato Yehelu Denekew, Director General of the Ethiopian Food, Medicines, and Healthcare Administration & Control Authority (EFMHACA). Inaugurating the proceedings this morning, Ato. Denekew emphasized that unregulated substandard and falsified medicines circulating in IGAD member states are, “…a serious public health threat which, if not prevented and controlled, will undermine confidence in public healthcare systems and programs.” He then added, “As chair of IGAD, Ethiopia supports efforts to study the prevalence of substandard and falsified medicines in cross-border areas. This will help the region develop necessary regulatory actions and interventions to control this problem.”

 


Fatuma Adan, Senior Regional Program Coordinator in IGAD’s Health & Social Development Division, called on the participants to review and finalize draft terms of reference for a Regional Expert Working Group on Pharmacovigilance & Post-Marketing Surveillance and submit such to the heads of the National Medicines Regulatory Authorities (NMRAs) for ratification and approval.



 Timothy Nwogu, PQM Principal Program Manager, remarked that approaching pharmacovigilance and post-marketing surveillance from a regional perspective is more than a question of cooperation.  “IGAD is fostering harmonization, and moving towards work-sharing and principles of mutual reliance,” he specified.

Paul Tanui of the New Economic Partnership for Africa Development (NEPAD) and Appollo Muhairwe of the World Bank also spoke at the opening ceremony to express support for the initiative.

IGAD GATHERS SUPPORT FOR ITS UPCOMING MEDICINES REGULATION PROGRAMME

03-08-2017, Addis Ababa (Ethiopia): The Intergovernmental Authority on Development (IGAD) today convened a meeting to sensitize development partners on the need for the region to establish a regional Medicines Regulation & Harmonization (MRH) Programme. The Acting Director of Health & Social Development, Ms Fathia Alwan, co-chaired the inauguration session along with the Deputy Chief of Mission (DCM) of Italy to Ethiopia and Chair of the IGAD Partners Forum (IPF), Giuseppe Coppola, with Dr Apollo Muhairwe of the World Bank-Uganda, and the Coordinator of the World Health Organisation’s Regulatory Systems Strengthening-Geneva, Dr. Michael Ward, at the high table.



This one-day meeting between IGAD development partners and Heads of National Medicine Regulatory Authorities (NMRAs) from IGAD Member States follows the 3rd Meeting of the latter held on August 1st and 2nd and which was aimed at, among other items on the agenda, readying an MRH project proposal.

Thus, the goals of this Donor Sensitization Meeting were to:

 



. Introduce the IGAD MRH initiative and results achieved so far;
. Present the approved IGAD MRH project proposal – including the financial and technical support expected; and
. Explore innovative ways and processes for resource mobilization.

Ms Fathia Alwan, in her opening remarks, linked the circulation of “Sub-standard and Falsified medical products and illegal trade in medicines in the region” to the movement of people. She also noted that “the presence of unregulated Sub-standard and Falsified medical products and illegal trade in medicines circulating within IGAD member states is a serious public health threat which must be prevented and controlled in order to spur confidence” before calling on the partners to support the initiative.

DCM Coppola informed the audience that the IGAD Partners Forum, that Italy was chairing, was made up of 27 states. He also acknowledged the other partners in attendance. “We welcome this initiative which is another key step to regional integration demonstrated by IGAD”, he said. He also added that IPF members will be duly informed an sensitized, while ways of mobilizing support will be considered.

Dr Apollo Muhairwe seized the opportunity to reiterate “that WHO will continue providing technical guidance and support to the IGAD MRH initiative, and also call upon AMRH partners; members of the IGAD Partners Forum (IPF) and other stakeholders to provide financial and technical support for the implementation of the proposal”.
Dr. Michael Ward highlighted that “the most challenging stage” was ahead. “Ensuring the continuity of the support from member states and mobilization of the financial support for the implementation of proposal are vital”, he said.

The meeting closed on a positive note with follow up pledges.

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IGAD Seeks Support for the First Ever Medicines Regulation Regional Initiative

01-08-2017, Addis Ababa (Ethiopia): The Intergovernmental Authority on Development (IGAD), in partnership with the World Health Organisation (WHO), inaugurated the 3rd Meeting of Heads of National Medicine Regulatory Authorities (NMRAs) at a session presided over by Dr. Eshetu Kebede from the Ministry of Health of Ethiopia, and in the presence of the Reproductive Maternal Child Health Coordinator-IGAD, Dr. Fatuma Adan, Dr Paul Mainuka of the World Health Organization (WHO)-Addis Ababa, and Dr Apollo Muhairwe of the World Bank-Uganda.
IGAD has embarked on developing a proposal aimed at improving access and availability of medicines through harmonization of regulatory systems, guidelines and processes among IGAD-NMRA’s in line with the Addis Ababa Call for Action of August 2015 and Khartoum Declaration of April 2016. Regulatory harmonization will achieve good control of pharmaceutical standards without impeding or obstructing the movement of pharmaceutical products within the region.
This 3rd Meeting of Heads of National Medicine Regulatory Authorities thus focuses on approving the IGAD Medicine Regulatory Harmonization (IGAD-MRH) Programme Proposal (to be submitted to potential development partners on August 3rd in Addis Ababa). It is also an opportunity for participants to validate and endorse the establishment of governance structure for the IGAD MRH Programme as well as the Terms of Reference of the IGAD MRH Expert Committees.

Dr. Esheteu Kebede, speaking for the Minister of Health of Ethiopia, noted that “the global illicit trade of fraudulent, sub-standard and otherwise dangerous medicines” was getting “a major regional challenge with its associated health problems” for the populations. He thus called, once again, on “international partners for perceived assistance on this delicate regional initiative”.
Dr Fatuma Adan, speaking on behalf of the Acting Director of Health & Social Development for IGAD Executive Secretary, highlighted, exception made of Kenya and Uganda which benefit from an East African Community MRH Project, the deficiency of regional support to IGAD Member States NMRAs due to lack of funds. She nevertheless pointed out to the fact that IGAD, with support from WHO and the World Bank, IGAD has come a long with the MRH Project Proposal being reviewed and adopted during these two-day long meeting.
Dr Mainuka declared that he was confident that the regional project proposal being discussed will “address the regulatory challenges, the proposed strategies and will further provide the right solutions”.
Dr Apollo lauded IGAD for the “development of the IGAD MRH Dashboard which enables sharing of publically available information on medicines in the region”. “NMRAs can use the platform to conduct a number of activities including information on status of registration of medicinal products”, he said.
The African Medicines Regulatory Harmonization Initiative has achieved a considerable harmonisation in several Regional Economic Communities on the African continent. However, there has been no harmonization initiative in the IGAD region so far. Currently, there is no funding to support medicine regulatory harmonization initiative in IGAD region; thus, the need to establish a structure and support this collaborative initiative in IGAD region. It is in this respect that IGAD called on a Donors Sensatisation Meeting to be held on August 3rd in Addis Ababa.

 

 

 

IGAD finalizes a Project proposal on Medicines Regulation

 

 

 

 

 

 

17-07-2017, Addis Ababa (Ethiopia): The Intergovernmental Authority on Development (IGAD) this morning opened the 1st Regional Experts Meeting on Medicines Regulatory Harmonization Initiative (MRHI) during an inauguration session chaired by Mr. Abdoulkader Walyei Fato from the Ethiopian Food, Medicine, and Healthcare Administration & Control Authority, and in the presence of the Reproductive Maternal Child Health Coordinator,Dr. Fatuma Adan, and Mr. Abraham Gebregiorgis of the World Health Organization (WHO) Geneva Office.
This two-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.
This 1st Experts Meeting is essentially aimed at reviewing and finalizing a draft project proposal for IGAD Medicines Regulatory Harmonization (IGAD-MRH) and establishing and IGAD Expert Committees for the Project.
Speaking on behalf of the Acting Director of the Health & Social Development Director for IGAD Executive Secretary, Dr. Fatuma noted that “the presence of unregulated Sub-standard, Falsified, and Counterfeit medicines circulating within IGAD member states” was “a serious public health threat which if not prevented and controlled, will undermine confidence in the public healthcare systems and programmes”. She highlighted that IGAD established the MRH Project with support from WHO and the World Bank despite the lack of proper funding within its Directorate.
Dr Fatuma reminded the audience that their inputs to the proposed draft project proposal were essential in view of submitting it the IGAD Heads of National Medicines Regulations Authorities (NMRAs) for ratification and approval in August 2017.
Mr. Gebregiorgis reassured the participants that “at global and regional level, WHO as the technical agency is supporting the regional economic communities medicine regulatory harmonization initiatives and in a broader level the NEPAD African Medicine Regulatory Harmonization”.
The Chair also his opening remarks before declaring the meeting officially open.
The
 expected meeting outcomes include:
• Draft IGAD-MRH Project Proposal;
• Draft One Year Project activities/work plan;
• Establishment of Expert Committees for IGAD-MRH project;
• Assessment meeting report and recommendations.

 
 

 

 

 

 

 

 

 

 

IGAD to Develop a Regional Medicines Assessment and Registration Guidelines

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.

 

IGAD Closes 1st Meeting on Medicines Regulation and Harmonization

28-04-2017, Entebbe, Uganda: The Intergovernmental Authority on Development (IGAD) today closed the First IGAD Committee Meeting on Information Management System and Medicines Assessment and Registration after ten days of intensive work which saw the finalization of recommendations by the Experts and the launch of a web site dedicated to serving as an information management tool for the IGAD Medicines Regulation and Harmonization (HRM) Program.

During a vote of thanks aimed at closing the meeting, it was noted that most objectives were achieved:

  1. a platform on regulatory information sharing was established (http://mrh.igad.int/);
  2. common products registered among the IGAD-National Medicines Regulation Authorities were uploaded into the web portal developed by the Management Information System experts;
  3.  Terms of Reference of Medicines Assessment and Registration Committee (MARC) by the assessment experts in the region was developed;
  4. a draft workplan for the MARC was developed;

It was also agreed in the recommendations that the next meeting of experts will be held end of July 2017.