IGAD Formulating Collaborative Pharmaceuticals Regulation, Possibility of Harmonization


IGAD member states are working to formulate regulatory system that would enable them to provide improved access to safe, effective and quality medicine for the IGAD population, according to the Executive Secretary of IGAD.

While speaking at the opening of the first IGAD Regional Medicine Regulatory Authorities Conference on Regulatory Collaboration and the possibility of Harmonization in Addis Ababa today, IGAD Executive Secretary Ambassador Mahboub Maalim said strong regulatory systems are needed to ensure the safety, quality and efficacy of medicines and medical supplies in the IGAD member states.He noted that participation in regulatory information exchange and collaboration, and harmonization networks is a mandatory situation to ensure effective medicine regulation.

The quality assurance mechanism is very weak in the IGAD region, mainly because of insufficient regulatory structures and capacity as well as lack of mandate to control the operation of procurement agencies, Ambassador Maalim pointed out.According to him, a significant portion of the population, especially in the nomadic pastoralist areas, is highly mobile; and this results in the uncontrolled movement of substandard and counterfeit medicines and medical products.

The Executive Secretary called upon member states and development partners to work out the modalities for establishing, strengthening, and harmonizing the regulatory system in the IGAD region.Ethiopian Health Minister, Dr. Kesetebirhan Admasu said on his part there are political and economic considerations, marketing strategies, human resources requirements, legal, regulatory and intellectual property constraints that should be addressed through regional collaboration.

He stated that there are three barriers for accessing health service in general, insufficient supply of high quality health commodity, inadequate capacity to effectively regulate these quality commodities and lack of access to information and awareness in using them, resulting in limited demand.It is possible to overcome these interrelated barriers, if we collaboratively work as a region and work together towards the common goal of improving access and quality of commodities and encourage local production of pharmaceuticals.

According to the minister, the burden of substandard, spurious, falsely labeled, falsified and counterfeit medical products is huge in our region. It is of paramount importance to address these challenges related the uncontrolled and unregulated circulation of this product.World Health Organization (WHO) Representative, Dr. Pierre Mpele said the recommendation of this conference will help the organization to better help the IGAD region.

The conference is designed to identify the strengths and limitations of the regulatory systems in the IGAD member countries and collaboration as well as possible stepwise harmonization of systems, it was learned.