MHRA：英国临床试验法规修订实施六个月，Route B 合格实质性修改平均七天获批
UK clinical trial reforms deliver seven-day approval for eligible trial modifications
英国修订临床试验法规生效六个月后，MHRA 报告 Route B 路径下合格实质性试验修改平均审批时间为七天。该路径经六个月试点，平均验证三天、审评四天，而监管最长期限为21天。MHRA 同时指出约3–5%的申请因文件缺失、表格未签名或文件不符合光学字符识别要求而未通过验证。
Six months after the UK’s revised clinical trials regulations came into force, the Medicines and Healthcare products Regulatory Agency (MHRA) has reported an average seven-day approval timeline for eligible substantial trial modifications under its Route B pathway.
The UK’s revised clinical trials regulations are supporting faster decisions on certain trial modifications, according to an update published by the MHRA on 28 October 2026.
Introduced on 28 April 2026, the regulations established a more flexible, risk-proportionate framework for clinical trial assessment. Under Route B, eligible substantial modifications can be processed more quickly where sponsors have no reason to believe that significant new safety concerns have arisen since the trial was originally approved.
Following a six-month pilot, the pathway has achieved an average validation time of three days and an average review time of four days, giving an end-to-end approval time of seven days. This compares with a regulatory maximum of 21 days for eligible Route B modifications.
The wider reforms also aim to streamline initial clinical trial applications, with sponsors submitting a single application for review by both the MHRA and a Research Ethics Committee (REC). The framework also allows sponsors up to 60 days to respond to requests for information, with final decisions issued within 10 days of receiving a response.
The MHRA also highlighted clinical trial application errors that can delay assessments. Approximately 3–5 percent of applications fail validation because of issues including missing documents, unsigned forms and files that do not meet optical character recognition requirements.
Pharmaceutical sponsors were advised to check that submissions contain all required documentation, with particular attention to investigational medicinal product (IMP) information, IMP labelling justifications and manufacturing and good manufacturing practice (GMP) details.
The update emphasises that complete, accurate submissions remain essential to avoiding delays under the revised framework.
来源：European Pharmaceutical Review · europeanpharmaceuticalreview.com