The COMESA region commands the largest market in Africa with an estimated total population of more than 583 million people and Gross Domestic Product of USD 805 billion. COMESA’s objective is to create a large economic and trading bloc capable of overcoming the constraints faced by individual Member States. The treaty establishing COMESA provides for facilitation of movement of pharmaceuticals and control of quality within the region and a meeting of the Council of Ministers meeting in Khartoum held in March 2003 noted variations in legislation and regulations among National Medicines Regulatory Authorities (NMRAs) and emphasised the need of harmonisation of the regulatory environment. The Council further observed that some of these decisions only require policy change and very little or no financing to implement while others require private sector intervention.

In response to the recommendations of the Ministers at the Khartoum meeting, a COMESA Medicine Regulatory Authorities Conference (CMRAC), a multi-disciplinary technical group was created. CMRAC held its first meeting in Lusaka from 13 – 15 June 2005, during which fifteen documents covering Minimum Technical Standards for Harmonisation (MTSH) were accepted to be used as a basis for harmonisation work. During the meeting, CMRAC established a Steering Committee consisting of Kenya, Uganda, Zambia, and Zimbabwe to prepare National Drug/Medicine Regulatory Authorities within member states for the harmonisation process. The steering committee held the first meeting on 4-5 September 2006 during which it reviewed the documents and agreed on a harmonisation programme. This was followed by a sensitisation workshop of the harmonisation programme and a CMRAC meeting in June 2009 and April 2010 respectively. Beyond that, the coordination of pharmaceutical activities within the COMESA Secretariat ceased as the funding envelope that was supporting it came to an end.

The Common Market for Eastern and Southern Africa (COMESA) has received a grant   from the African Development Fund to finance the COMESA Support Towards Regional Pharmaceutical Sector Development (CSTRPSD) to support development of the pharmaceutical sector in the region and one of the outputs of the project is to support re-establishment and operationalisation of the COMESA Pharmaceuticals Committee and ensure that it is sustainable.

2.0 Objectives of the Project

The principal objectives of the project are to provide institutional support for the development of the pharmaceutical industry through strengthened capacities of the region’s pharmaceutical regulatory bodies, quality control and management systems, research, and development institutions for effective manufacturing of safe and quality pharmaceutical products in the region.

The specific objectives include:

• The institutionalisation and domestication of the Pharmaceutical Manufacturing Plan for Africa (PMPA) and the African Medicines Regulatory Harmonisation (AMRH) programme;
• Strengthening of the region’s medicines and pharmaceutical regulatory bodies/institutions in the region; and
• Building the capacity of key stakeholders and support trans-regional research and development programmes.