Scientific confab on medical products begins in Accra

Mr KJwaku Agyeman-Menu (inset) addressing participants at the conference.Photo Seth OsabukleThe third Biennial Scientific Conference on Medical Products Regulation in Africa is underway in Accra.

Organised under the theme “Sustaining the Momentum for Regulatory Harmonisation in Africa”, the conference seeks a collaborative approach in improving the fragmented regulatory system for medicinal products registration across the continent.

The two-day event also offers the opportunity for a review of the progress made in strengthening regulatory systems and harmonisation since the operationalisation of the African Medicines Regulatory Harmonisation (AMRH) in 2009, which was aimed at galvanising regional economic communities towards achieving regional harmonisation.

Addressing participants from various countries in Africa, Mr Kwaku Agyeman Manu, Minister of Health said some African countries take about four years or more to get access to global health medicinal products due to the absence of technical capacity, resource constraints, different technical and administration requirements and failure to leverage regulatory review activities.

He said harmonisation was necessary to address the challenge to ensure quality and safety of medical products in the region and further prevent duplication of efforts by member states.

The minister explained that the AMRH was set up to tackle the gaps through the regional economic communities without compromising on the safety of the medicinal products and urged member states to consolidate efforts in reducing delays in administrative and technical processes in accessing medicinal products.

So far, the AMRH, Mr Manu noted has led to the development of the harmonised good manufacturing practice (GMP) guidelines and joint inspections of products filed on the centralised procedure to be supplied throughout the eastern part of Africa.

It further ensured 35 medicinal products were assessed using the centralised procedure with about eight products receiving regulatory decisions and facilitated the development of a draft legislative framework of substandard and falsified medicines and illicit trade in medicines by the Council of Ministers of all member states in the Economic Community of West African States (ECOWAS) region, he added.

Other benefits of the AMRH, he said included an agreement on a common technical document for medicine registration with support from the World Health Organisation (WHO) which was in the process of being validated as well as the drafting of a strategy and plan for clinical trials and drugs production between African countries.

Dr Xavier Crespin, Director General, WHO Representative in Ghana, stated that access to medicinal products was a major key in promoting a healthy life for citizens, saying that such collaborative efforts were necessary to improve regulatory systems that ensure the availability of medicinal products in the various countries at all times.

He reiterated the need for harmonised regulations on medicinal products to deal with the threat of falsified and substandard medicines, adding that WHO would continue to support initiatives including the establishment of the African Medicine Agency and provide training to enhance the safety of health systems.


By Claude Nyarko Adams


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