印度计划修改药物试验规则,以缩短申请时间并提高效率。 India plans to amend drug trial rules to cut application times and boost efficiency.

印度联邦卫生部计划修订《新药物和临床试验规则》,以简化程序和缩短遵守法规的时间。 The Union Health Ministry in India plans to amend the New Drugs and Clinical Trials Rules to simplify procedures and reduce regulatory compliance times. 关键的变化包括:将测试许可制度转换为通知程序,将申请处理时间从90天缩短到45天,为某些生物利用率/生物等值研究发放许可证。 Key changes include converting the test license system to a notification process, reducing application processing time from 90 to 45 days, and dispensing with licenses for certain Bioavailability/Bioequivalence studies. 预计这些改革将使许可证申请数量减少约50%,加快药物开发,并提高监管效率。 These reforms are expected to cut the number of license applications by about 50%, speed up drug development, and improve regulatory efficiency.