Medicine data: rare disease (orphan) designations

Information on rare disease (orphan) designations based on applications that have been assessed by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by the COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question. Search results can be exported in Excel format.本数据集涵盖经欧洲药品管理局（European Medicines Agency, EMA）孤儿药品委员会（Committee for Orphan Medicinal Products, COMP）评估的申请所关联的罕见病孤儿药认定（orphan designation）相关信息。 孤儿药认定可使制药企业享有欧盟为推进罕见病药物研发提供的各类激励政策，具体包括申请费用减免以及药物上市后免受市场竞争的保护。孤儿药认定申请由孤儿药品委员会审核，该委员会将出具审评意见并提交至欧洲委员会，随后欧洲委员会将对是否授予该药物孤儿药认定作出最终裁定。 搜索结果可导出为Excel格式。