中国皮肤科药物创新研发及审评审批进展

Progress in development,evaluation and approval of new drugs for skin disease in China

药品审评审批制度改革以来,在一系列鼓励创新的政策和技术支持下,大批皮肤科治疗新药获批临床试验,创新药、高质量仿制药和生物类似药加速上市,在一定程度上满足了药物的可获得性和可及性。为了更好地指导皮肤科治疗领域药物创新及科学研发,本文梳理了我国药品审评审批制度改革、药品监管体系持续完善、皮肤科药物创新研发及审评审批进展情况,重点关注该治疗领域药物在研发、评价和监管中面临的挑战、机遇及改进措施。通过多措并举,最终目标是为了满足皮肤科患者临床用药的迫切需求,使安全有效的药物尽早惠及患者。

Since the reform of the drug review and approval system,with the support of a series of policies and technology that encourages innovation,a large number of clinical trial application of new drugs for skin disease has been approved.In addition,innovative drugs,high⁃quality generic drugs,and biosimilar products have been accelerately approved,which meets the availability and accessibility of drugs to a certain extent.In order to guide innovation and scientific development of new drugs for skin disease,this article reviews the reform of drug review and approval system,the continuous improvement of the drug regulatory system,and the progress in development,evaluation and approval of new drugs for skin disease in China.We focus on the challenges,opportunities,and improvement measures faced in the development,evaluation,and regulation of drugs in this field.With multiple measures simultaneously taken,the goal is to meet the urgent clinical medication needs of patients with skin disease,so that effective and safe drugs can benefit patients as soon as possible.