欧盟优先药物计划简介及对我国的启示

Brief introduction to priority medicines scheme in European Union and its inspiration for China

为加快临床需求未满足领域的新药的开发和上市,欧洲药品管理局(EMA)于2016年推出了“优先药物计划(PRIME)”,并为获得该项资格的药物在不同开发阶段提供了一系列支持举措,包括任命EMA的专门人员辅助申请人、在重要开发阶段向申请人提供多次与监管部门交流的机会、协助申请人制定/调整药物开发计划和监管策略、促进药物研发与上市审评的衔接等,以加快优先药物上市申请的审批。截至2021年上半年,EMA共收到384份PRIME资格申请,其中有95份获得批准,涉及抗肿瘤药、血液系统用药和神经系统用药等19个治疗领域。建议我国相关部门可借鉴EMA的做法,在项目管理、沟通交流会议管理、审评资源利用及审评质量管理等方面加强建设,以完善我国突破性治疗药物制度。

To accelerate the development and market launch of new drugs that address unmet clinical needs,the European Medicines Agency(EMA)launched the“priority medicines(PRIME)”scheme in 2016.A range of supportive measures have been provided to drugs granted this qualification at various stages of development,including the appointment of dedicated personnel from EMA to assist applicants,multiple opportunities for applicants to engage in dialogue with regulatory authorities at key developmental stages,assistance in formulating or adjusting drug development plans and regulatory strategies,and facilitating the transition from drug development to market authorization review,thereby expediting the approval process for drug market applications.As of the first half of 2021,EMA had received a total of 384 PRIME qualification applications,of which 95 were approved,covering 19 therapeutic areas including antineoplastic medications,hematological medications,neurological medications,etc.It is suggested that relevant departments in China may draw on the practices of EMA to strengthen the construction in project management,management of communication and exchange meetings,utilization of review resources,and quality management of the review process,in order to improve the system for breakthrough therapeutic drugs in China.