West Africa to harmonise medicines registration

DrugsTo ensure affordability, safe, quality and efficacious medicines on the African continent, the West Africa Medicines Registration Harmonization Project and Steering Committee of African Union Model Law, has been launched in Accra.

Dr Kweku Agyeman-Mensah, Minister of Health, said the project would help fast track the registration of good quality medicines in member states to treat priority diseases and strengthen local the pharmaceutical industry, develop regional anti-counterfeiting strategies and strengthen quality control laboratories.

The Health Minister noted that lack of clear policies, legal and regulatory frameworks for regulating medicines in many countries hindered efforts in improving medicines regulations in Africa.

He also expressed concern about the free movement of pharmaceuticals leading to numerous challenges in the pharmaceutical sector, including easy access to Sub-standard and counterfeit medicines.

The Minister stated: “The National Medicines Regulatory Authorities (NMRAs) cannot take their rightful place when the legal provisions establishing them are weak and do not address current issues regarding medicine and other health commodity regulation, and there is the need to have the legal basis of the agencies so that the scope of activities of the NMRAs will be covered under the legal provisions”.

In all 15, countries are participating in the four-day meeting under the auspices of World Health Organisation (WAHO), ECOWAS and NEPAD.

Dr Agyeman-Mensah explained that registration harmonization would prevent duplication of clinical trials in humans and minimise the use of animal testing without compromising safety and effectiveness.

“As a region, we share a common disease burden, diseases that are a heavy burden in terms of both morbidly and mortality and the affordability of quality medicines for treatment of these diseases remain a key challenge,” explained.

He named other challenges as inadequate procurement mechanisms, inadequate distribution systems, limited public financing , lack of research and development and low capacity, and called for the model law for national regulatory to cover activities such as marketing authorization for health products, post market surveillance, import and export control, inspections and enforcement activities, licensing of facilities, as well as ’pharmacovigilance’ activities.

Mrs Sybil Ossei-Agyeman-Yeboah, Programme Officer of Medicines and Vaccines at WAHO, explained that harmonization of medicines had been identified as a means to improve transparency in medicines management, removal of technical barriers to trade in the region as well as the illegal sale of medicines in markets and moving vehicles.

She stated that the Model Law of Medical products Regulation and Harmonization in Africa “seeks to provide guidance to countries in undertaking a review of national legislation and to propose an enabling model for the institution of an effective national medical product regulatory agency”.

The Model Law will be supplemented by framework regulations to be developed, taking into account the identified needs of countries and their respective regional economic communities.

The Chairman of Ghana’s Parliamentary Select Committee on Health, Mr Joseph Y. Yieleh Chireh, pledged Parliament’s support in working with the team to fine-tune the law for its full implementation.

Representatives from WAHO, ECOWAS, West African Economic and Monitoring Unit, Pan African Parliament, Bill and Melinda Gates Foundation, UNAIDS, Global Fund, WHO, West African Pharmaceutical Manufacturers Association, Federation of African Pharmaceutical Manufacturers Association, and the International Federation expressed their support for the implementation of the Model law and ensure harmonization in the sub region.

Source: GNA

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