EMA Shifts Gear On Patient Feedback During Drug Review
Pilot To Focus On Orphan Medicines For Which CHMP Review Is Imminent
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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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.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.