印度通过更快的许可证发放和在线提交,简化了药物批准程序,将开发时间缩短了90天以上。 India streamlines drug approvals, cutting development time by 90+ days via faster licensing and online submissions.

印度更新了《新药物和临床试验规则》,将药物研制时限至少缩短90天。 India has updated its New Drugs and Clinical Trials Rules to cut drug development timelines by at least 90 days. 除高风险药物外,这些改动将非商业性药物制造试验许可证要求改为事先在线通知CDSCO,并将许可证处理时间从90天减少到45天。 The changes replace test licence requirements for non-commercial drug manufacturing with a prior online intimation to CDSCO, except for high-risk drugs, and reduce licence processing time from 90 to 45 days. 低风险的BA/BE研究不再需要事先批准,允许在入室后开始。 Low-risk BA/BE studies no longer need prior approval, allowing them to begin after intimation. 通过国家单一窗口系统和SUGAM门户网站在线提交材料将提高透明度和效率,支持更快的监管审查并促进制药创新。 Online submissions via the National Single Window System and SUGAM portal will improve transparency and efficiency, supporting faster regulatory review and boosting pharmaceutical innovation.