Health · Healthcare & Policy · 54 mins ago
Countries move to shorten reviews for new-drug clinical trials
Countries are trying to speed up clinical trials for new drugs while keeping safety checks.
In the United States, the FDA is testing a process that lets companies submit completed parts of their applications one at a time, after expert research groups review them.
The FDA is also testing real-time sharing of trial safety and effectiveness information for selected studies.
China has introduced a review system that cuts the stated approval period for innovative-drug trials from 60 days to 30, while the UK is pursuing a 14-day target for low-risk first-stage trials and Denmark has set a 14-day notice period for early trials.
South Korea plans to cut its review period from 30 days to 10 when an application passes an advance review.
Faster entry into early trials could help countries compete in drug development, and the FDA plans to choose eight to 10 trial-and-review groupings for its pilot around mid-December.
Countries are changing clinical-trial rules to shorten reviews and speed the development of new drugs while maintaining safety.
The United States is testing sequential submission of trial materials and faster sharing of information between regulators and companies.
China has introduced a system to cut review and approval of innovative-drug trials from 60 days to 30 days.
The United Kingdom is pursuing a reduction in its review target for low-risk Phase 1 trials from 30 days to 14 days.
South Korea plans to reduce the approval period for trial applications from 30 days to 10 days when preliminary review results are suitable.
- Who
- Drug regulators in the United States, China, the United Kingdom, Denmark and South Korea.
- What
- They are pursuing or introducing measures to shorten reviews for new-drug clinical trials.
- When
- The article was published on November 14, 2026. Some measures are already in place, while others are planned or being tested.
- Where
- In the United States, China, the United Kingdom, Denmark and South Korea.
- Why
- To speed up clinical trials and new-drug development while maintaining safety.
This story does not have two clearly opposing sides.
The US Department of Health and Human Services announced an innovation policy to promote clinical trials and new-drug development.
The FDA's recruitment period ended for companies seeking to join its expedited IND pilot program.
The FDA is expected to notify 8 to 10 selected company and qualified research institution pairings for the pilot.
- South Korea's planned IND period
- 30 days to 10 days when preliminary review results are suitable
- China's review period
- 60 days to 30 days for innovative-drug clinical trials
- United Kingdom's proposed target
- 30 days to 14 days for low-risk Phase 1 trials
- Denmark's early-trial notification
- Within 14 days, a policy announced in August 2025
- FDA pilot selections
- 8 to 10 company and qualified research institution pairings expected in mid-December 2026
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What people are saying
In the global new-drug development environment, how quickly promising candidates can enter early-stage clinical trials is emerging as one factor that determines competitiveness.
In South Korea, efforts are continuing to make the administrative procedures required to enter clinical trials more efficient and to establish a regulatory environment that supports new-drug development.