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  • Regulatory NewsRegulatory News

    EMA Issues Guidance on Clarification Meetings

    The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015. The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure. Clarifying Objections EMA believes increasing transparency between the agency and applicant...