EMA Brings Non-EU Regulators Into CHMP Meetings
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.
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Non-EU countries can send their regulators to take part in EMA committee meetings even if they do not have confidentiality arrangements in place with the agency.
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.
The European Medicines Agency is planning to expand the involvement of patients in benefit-risk evaluation of medicines following a successful pilot, but one EU patient group has advised drug companies not to contact patients during their visits to the agency as this could lower the value of their input.