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EMA Shifts Gear On Patient Feedback During Drug Review

Pilot To Focus On Orphan Medicines For Which CHMP Review Is Imminent

Executive Summary

The European Medicines Agency is exploring the feasibility and utility of contacting patients’ organizations for their input as soon as its medicines evaluation committee starts reviewing a new drug.

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EMA Starts Seeking Patient Feedback Earlier For Orphan Drug MAAs

A 17-month pilot by the European Medicines Agency has highlighted the benefits of obtaining the views of patients much earlier on in the review of marketing authorization applications for orphan drugs.

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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.

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