UK Introduces "Approval-Free Clinical Trial Amendments" System Amid Global Regulatory Easing Race

Pilot Operation to Begin on October 1
UK Launches Route B to Accelerate Clinical Trial Amendments Without Separate Approval
Global Trend Toward Streamlined Clinical Trial Regulations

The UK government is introducing a new pathway, Route B, which will allow significant changes to clinical trials to be made without a separate approval process as part of its clinical trial regulatory innovation. This move is seen as part of the global competition to dramatically shorten clinical trial approval procedures and accelerate new drug development.

According to the industry on September 1, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will begin a pilot operation of the "Route B Substantial Amendment Process" from October 1 to October 31. Under this system, if predefined requirements are met, companies can automatically implement "substantial amendments" to clinical trials without MHRA approval. The official implementation is scheduled for April 28 next year.

As a result, the existing "Type A Voluntary Notification Scheme" for clinical trials will end at the end of September this year, and from April next year, all will be unified under "Notifiable Trials."

The relaxation of clinical trial regulations is not unique to the UK. Since August, the Danish Medicines Agency has been notifying applicants of approval decisions for single-country Phase 1 and Phase 1-2 clinical trial applications within 14 days. China is also pushing for a revision to shorten the clinical trial approval waiting period from 60 days to 30 days, which would introduce a "30-day automatic approval system" similar to that of the US Food and Drug Administration. In June, the United States joined the race for speed by introducing the "Country Priority Voucher (CNPV)" program, which reduces new drug review times to one to two months.

This latest move by the UK demonstrates that the clinical trial regulatory paradigm is rapidly shifting from "ensuring safety" to "promoting innovation." It is expected that global pharmaceutical companies will increasingly move their clinical trial bases to countries with more flexible regulatory environments, such as the UK, Denmark, and China.