美国和欧盟的药品沟通交流制度研究及启示

Study and enlightenment on drug communication system in US and EU

比较美国和欧盟的药品沟通交流制度和运行方式,为完善我国药品沟通交流制度提出建议。检索和梳理美国、欧盟的创新药、复杂仿制药、孤儿药、生物类似药等药品的沟通交流制度,分析我国药品沟通交流制度的实施现状并提出相应建议。美国和欧盟根据药品研发生命周期和产品特性建立了针对不同类型药品的沟通交流会议,并积极与国际上其他监管机构和利益相关方共同开展沟通交流,助力新药研发。相较而言,我国现有药品沟通交流会议类型对产品特性的针对性略显薄弱,沟通交流的答复仍有不足,还需积极寻求国际合作的机会。我国沟通交流制度尚无法完全满足申请人的药品研发指导需求,借鉴国外沟通交流制度的经验和思路,我国应细化沟通交流会议的类型,尝试与国际其他监管机构达成审评合作,提高沟通交流的答复质量和透明度,提高药品的研发和审评效率。

To compare the drug communication system and operation mode of FDA and EMA,and put forward the suggestions for improving the drug communication system in China.The communication systems of innovative drugs,complex generic drugs,orphan drugs,biosimilars of FDA and EMA were collected and sorted out.The implementation status of China's drug communication system was analyzed,and the corresponding suggestions were put forward.FDA and EMA have established communication system for different types of drugs based on the drug development life cycle and product characteristics,and actively engaged with other international regulatory agencies and stakeholders to facilitate new drug development.In contrast,the existing types of drug communication systems in China are slightly weak in terms of product characteristics,and the responses to communication are still insufficient.China still needs to actively seek the opportunities for international cooperation.China's communication system is still unable to fully meet the needs of the applicant's drug research and development guidance.Based on the experience and ideas of foreign communication systems,China should refine the types of communication system,try to build review cooperation with other international regulatory agencies,improve the quality and transparency of replies,as well as the efficiency of drug research and development and review.