East African Community looks to EMA as model for future regional agency

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23/05/2017

East African Community looks to EMA as model for future regional agency

EMA and East African regulators met on 18-19 May 2017

As part of the European Medicines Agency’s (EMA) ongoing collaboration with African regulators, a delegation from the East African Community (EAC) visited the Agency on 18-19 May 2017. The goal of the two-day meeting was to gather information and experience to support the potential creation of a networking medicines agency for the EAC.

The delegation included the heads of national agencies from the EAC Partner States, together with representatives from the World Health Organization (WHO) and the World Bank Group. The EAC has six Partner States: Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda.

Participants discussed the structure and operations of EMA as a model for a regional networking agency that coordinates the work of the national regulatory agencies in the EU in the assessment of human and veterinary medicines. Discussions focused on the approval and lifecycle management of medicines, pharmacovigilance and inspections as well as organisational aspects such as human resources management, training, information technology and infrastructure, and internal controls.

EAC was the first ‘Regional Economic Community’ in Africa to embark on cooperation in the regulation of medicines, beginning in 2012 with harmonisation of legislation under the African Medicines Regulatory Harmonisation initiative. The EAC is an official observer to the International Council for Harmonization (ICH) and a member of the International Pharmaceutical Regulators Forum (IPRF).

This meeting follows the workshop with EMA’s Committee for Medicinal Products for Human Use (CHMP) and African regulators held on 2-3 March 2017 that looked at how to promote reliance on the scientific output of the CHMP, and in particular the Agency’s ‘Article 58 procedure’ for global health products intended for use outside of the European Union.

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