Accra, 06 October, 2015 - The first WHO implementation workshop organized by the WHO/HIS/EMP in collaboration with the Ghana Food and Drugs Authority was held from 8-19 September at the Fiesta Royale Hotel in Accra. This workshop presented the opportunity for NRA’s in the African region to discuss regulations on Biologicals, vaccines, and other bio-therapeutics in the African region which is an entirely new experience for most NRAs in the African region.

The workshop was held as a step towards the implementation of principles for the WHO guidelines and discussed regulatory assessment and to give regulators insights for dealing with situations where products were licensed using a pathway which did not follow globally agreed and relevant regulatory expectations. Most NRA’s in the African Region needed to be aware of the WHO guidelines on evaluation of similar bio-therapeutic products and also guidelines on the quality, safety and efficacy or bio-therapeutic protein products cannot be overemphasized.

The workshop was attended by about 40 experts including 27 regulators from 16 African countries (Algeria, Botswana, Burkina Faso, Burudi, Ethiopia, Gambia, Ghana, Kenya, Mozambique, Nigeria, Sierra Leone, South Africa, Tanzania, Uganda, Zambia and Zimbabwe)

The 67TH World Health Assembly Resolution (2014) emphasizes the critical needs in the bio-therapeutics area in order to promote access to these products as well as ensure the quality, safety and efficacy requests WHO to support national regulatory authorities to develop national regulatory frameworks to meet current/international regulatory expectations. The WHO guidelines on evaluating similar bio-therapeutic products (SBP) were adopted by the Expert Committee on Biological Standards (ECBS) in 2009 and 2013 respectively.

In his statement during the opening of  the meeting the WHO Representative for Ghana, Dr Prosper Tumusiime reiterated the Ebola Virus Disease situation as a learning opportunity for strengthening the health system and in particular strengthening regulatory agencies for development of vaccines and other biologicals. He appreciated the work that the Ghana Food and Drugs Authority has been doing in the area of introduction of new vaccines and biologicals in the country.  He said that there is a need for Regional Economic Committees in health to bring together countries to support each other and to make regulatory decisions simpler between countries seeking to harmonize regulatory processes. He concluded that the e-learning experience offered to the participants before the workshop afforded them the opportunity to learn more after the workshop in countries to build systems for the National Regulatory Agencies in this area.

During the workshop the WHO draft document on regulatory assessment of approved bio-therapeutic products was discussed and approved as a standard to set up the national requirements in African countries

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For further information please contact:

Dr ProsperTumusiime, WHO Representative a.i. Ghana, email: tumusiimep [at] who.int

Ms Edith Andrews-Annan, EDM Officer, WHO Ghana, email: andrewse [at] who.int

Ms Joana Ansong, Health Promotion Officer, WHO Ghana, email: ansongj [at] who.int