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近日,由上海市医学会罕见病专科分会、中国药科大学、南京医科大学联合主办的“2013年孤儿药界定与市场准入全国学术研讨会”在中国药科大学顺利闭幕。长期以来,由于罕见病患者人群少、市场需求小、研发成本高,很少有企业愿意关注其治疗药物的研发,因而此类药品被形象地称为“孤儿药”。而我国政府现今尚未界定孤儿药等相关定义,也缺乏完善有效且具备可操作性的孤儿药准入政策。为唤醒社会各界对罕见病患者的关注,以及对我国孤儿药产业发展的支持,围绕“强化市场准入,关爱罕见病患者”的主题,来自国家食品药品监督管理总局法制司、药品化妆品注册管理司,国家人力资源和社会保障部
Recently, the 2013 National Conference on the Definition and Market Access of Orphan Drugs jointly sponsored by the Shanghai Medical Association Rare Diseases Branch, China Pharmaceutical University and Nanjing Medical University ended successfully at China Pharmaceutical University. For a long time, due to the small population of rare diseases, the small market demand, high research and development costs, few companies are willing to pay attention to the development of therapeutic drugs, and thus these drugs are vividly called “orphan drugs.” However, our government has not defined the related definition of orphan medicine nowadays and lacks the effective and operable orphan drug admission policy. In order to arouse the concern of all walks of life in the rare diseases and support for the development of orphan medicine industry in our country, the theme of “Enhancing Market Access and Care for Patients with Rare Diseases” came from the Legal Division of the State Food and Drug Administration, Registration Management Division, Ministry of Human Resources and Social Security