FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

European Commission Calling for Patient Organizations to Help Oversee Orphan Products

Dec. 7, 2017
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The European Commission’s Directorate-General for Health and Food Safety, DG-SANTE, is calling for patient advocacy organizations to fill three open positions on the European Medicines Agency’s Committee for Orphan Medicinal Products.

The COMP examines orphan designation applications, limited to rare conditions that affect no more than five in 10,000 people in the European Union.

The new patient representative members will participate in monthly committee meetings alongside members nominated by each member state, plus Iceland and Norway, as well as three additional members recommended by the EMA.

The patient organization members will be appointed for a renewable, three-year term starting July 2018. The deadline for submissions is Dec. 20.

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