Could The EMA Be A Regulatory Model For East Africa?
A meeting between the European Medicines Agency and representatives of the East African Community discussed whether the European agency could act as a model for a regulator in the six-country region.
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A report by the European Medicines Agency and the regulators from the East African Community has outlined the possible shape of a regional regulator in east Africa.
The European Medicines Agency is continuing with its plans to involve non-EU regulators in scientific reviews. It notes in its 2016 activity report that Israeli regulators for the first time took part in a CHMP meeting.
The European Medicines Agency is looking into how it can better promote the Article 58 procedure under which it evaluates the quality, safety and efficacy of medicines or vaccines intended for use outside the EU. The procedure has been underutilized by industry to date and the EMA wants to encourage its use, especially for drugs to be used in Sub-Saharan Africa.