国家食品药品监管局发布药品审评审批改革措施鼓励药物创新 State food and drug supervision bureau released drug approval for examination and approval reform measures to encourage drug innovation

　　国家食品药品监督管理局26日发布《关于深化药品审评审批改革进一步鼓励创新的意见》，通过调整药品审评审批策略，鼓励具有临床价值的药物创新和儿童药物的研制。

The state food and drug administration issued 26[To further the reform of drug approval review further encourage innovation],By adjusting the policy for examination and approval of drug approval,Encourage has clinical value of drug innovation and the development of medicines for children.

　　国家食品药品监管局药品注册司司长王立丰在新闻发布会上介绍，意见在2007年修订的《药品注册管理办法》和2009年出台的《新药注册特殊审批管理规定》的基础上，对药品技术注册审评工作进行了完善和调整。意见更加注重创新药的临床价值，鼓励有临床需求、具有较好治疗作用等具有自主知识产权的药物研制，对这些药物将加快审评。此外，依据研发规律，意见对创新药的资料要求更加科学合理。如以往新药注册时要求在申报时就提供完整的剂型、规格、工艺甚至质量标准等资料，而且不可变更。现在则可以根据研发进展，逐渐探索、逐步明确，依据科学数据，阶段性增补、变更和完善申报资料，在创新药申报生产时才要求提供上述完整资料。

The drug registration division of China's state food and drug supervision bureau Wang Lifeng at a news conference,In the 2007 revision of the comment[Drug registration management measures]And in 2009[New drug registration special provisions for the administration of examination and approval]On the basis of,The drug registration review of techniques to improve and adjust.Pay more attention to the innovation medicine clinical value,Encourage with clinical needs/Has a good therapeutic effect with independent intellectual property rights, such as drug development,Will speed up the review of these drugs.In addition,According to research and development,Comments on the documents demanded of innovative drug is more scientific and reasonable.As ever the requirement when new drug registration declaration when you provide the complete formulations/specifications/Process and quality standards etc,And do not change.Now you can according to the research and development progress,Gradually explore/A clear step by step,Based on the scientific data,Periodically supplemented/Change and improve the declared data,When filing the innovation medicine production is required to provide the complete information.

　　意见规定，对于仿制药审评，将确定优先审评领域。属于临床供应不足、市场竞争不充分、影响公众用药可及性和可负担性的药品，儿童用药、罕见病用药和特殊人群用药以及其他经评估确认为临床急需的药品，实行优先审评。

Opinion rules,For generic drug review,Will determine the review priority areas.Belong to the clinical are in short supply/Market competition is not sufficient/Influence public drug accessibility and affordability of medicines,Medicine for children/Drug use and other rare diseases drugs and special people confirmed by the assessment for urgent clinical needs of drugs,A priority review.

　　为加强药物临床试验质量管理，意见明确提出，要提高伦理委员会伦理审查水平，确保药物临床试验伦理审查的独立性，确保伦理委员会能够履行保护受试者权益和安全的职责。

To strengthen quality management of drug clinical trials,Opinion clearly put forward,To improve the level of ethics committee for ethical review,To ensure the independence of the ethical review of clinical trials,Ensure that ethics committees can protect the safety of subjects' rights and responsibilities.

　　王立丰介绍，针对我国儿童药缺乏的现状，意见还专门就儿童药物研发提出鼓励措施。鼓励生产企业积极研发仿制药的儿童专用规格和剂型。对儿童专用规格和剂型的申请，立题依据充分且具有临床试验数据支持的优先审评。(记者胡浩)

Wang Lifeng introduction,In view of the situation of lack of children's medicine in China,Opinion is specialized drugs for children encourage measures are put forward.Research, production enterprises to actively encourage generic specifications and formulations for children.Special specifications and formulations for children,LiTi based on full and has a priority review of clinical trial data to support.(The reporter Hu Hao)