FDA announced plans to increase oversight of clinical trials overseas while proposing a pilot to shorten and remove barriers in the IND process as a means to increase US-based research and counter shifts to ex-US R&D.

By Patricia Van Arnum, Editorial Director, DCAT, [email protected]

The US Food and Drug Administration (FDA) announced this week a plan to expand its oversight of clinical trials overseas as it seeks to develop a pilot program that would shorten the time it takes from drug identification to first-in-human Phase 1 clinical trials. These actions reflect the interest of the US to strengthen domestic R&D and increase clinical trial activity to address the rising role of ex-US R&D, particularly in China.

The rise of China in R&D: the numbers
The numbers tell the story of the increased role of China in R&D. In 2021, China’s global share of Phase I trials surpassed the United States’ share for the first time. In 2024, China surpassed the United States in the total number of clinical trials registered, with over 7,100 registered, representing 39% of global trials, according to information from the US Department of Health and Services (HHS).

China’s ascent as a major R&D player is reflected in the increased domestic trial activity and increased deal-making with international companies. Trial starts from China-headquartered sponsors have mainly been driven by domestic-only trials, referring to those that were exclusively conducted in China, which account for between 75% and 88% of China-headquartered sponsor trials, according to a recent analysis by the IQVIA Institute of Human Data Science. This high level of domestic trial activity has also resulted in China becoming a top location globally for industry-sponsored single-country trials by Emerging Bio/pharma companies. In addition, licensing deals and mergers and acquisitions (M&A) between China-headquartered bio/pharma companies and international companies overall surged to an all-time high in 2025, with almost half of these deals involving a US partner, according to the IQVIA Institute analysis. The overall number of international deals for China-based companies surged in 2025, with 94 M&A or licensing deals, up from 71 in 2024, and with the largest increase from North American companies, predominately the US, followed by European companies.

US government seeks to turn the tide
Given the rising role of China in R&D, particularly early-stage research, the US government is moving forward with a plan to facilitate early-stage research in the US at the same it is increasing its oversight of clinical trials conducted overseas.

In June (June 2026), HHS announced the launch of “Operation TrialBlazer,” a coordinated US government effort to identify and remove barriers to clinical research in the US, increase participation in clinical research, and strengthen domestic research capacity.

“[I]n recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation,” said HHS in a June 22, 2026, statement in announcing the launch of Operation TrialBlazer. “…HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery. “

FDA says it is “committed to reversing the current trajectory of research leaving the US” by focusing on two strategic priorities: (1) accelerating the time to first-in-human clinical trials by addressing the regulatory requirements for IND applications and reimagining the pre-IND phase and (2) accelerating later-stage clinical development and reducing administrative burden by pursuing Institutional Review Board reform and increasing trial access and participation. Details of certain key priorities are highlighted below.

Pilot in the IND process. A key part of the plan is a proposed pilot program to shorten and remove barriers in the investigational new drug (IND) process. FDA is soliciting public comments on a proposal to develop a pilot program that would shorten the time it takes from drug identification to first-in-human Phase I clinical trials. By focusing only on risk-based and phase-appropriate requirements, FDA believes sponsors can save up to 6 to 12 months of development time versus current IND submissions.

Reducing trial timelines. In June (June 2026), FDA issued draft guidance clarifying that, in many cases, one high-quality late-stage clinical trial with confirmatory evidence will generally be sufficient to provide substantial evidence of effectiveness in support of a drug approval.

Streamlining CMC data requirements. FDA is also clarifying what sponsors of chemistry, manufacturing and controls (CMC) data should submit before a Phase I clinical trial. To this end, FDA has released a webpage clarifying common Phase I CMC data misconceptions to streamline CMC data requirements.

For advanced therapies (i.e., cell and gene therapies) to address the high cost of manufacturing, FDA plans to expand the use of prior knowledge from standardized and well-understood methods of manufacturing and drug delivery so that sponsors can reuse data from one product to support the next product to reduce time and cost and incentivizing the use of platform knowledge to support future submission.

Increasing oversight of clinical trials overseas
FDA also announced in an agency blog that it is taking several concrete actions to address challenges in the oversight of overseas clinical trials as outlined below.

Expanding inspection coverage. FDA is adding resources for foreign Bioresearch Monitoring inspections to expand oversight at foreign clinical trial sites, including through inspecting more Phase I and early-stage trials, and by expanding the scope of some inspection assignments to include more trials occurring at the facility. FDA is also planning updates to the risk-based criteria it uses to help identify sites for inspection to better reflect compliance risks for trials conducted in specific countries or regions.

Improving communication with sponsors. FDA says it is being more systematic about communicating to sponsors and the public when trial sites and relevant personnel and documents have not been available for inspection, or where inspections were conditioned on agreements FDA cannot execute. Sponsors who are considering relying on data from those sites should factor this information into their regulatory strategy from the outset.

Strengthening internal reviewer training. FDA is providing additional training for medical product reviewers to help them identify clinical trial sites where there may be concerns about whether studies have been conducted in accordance with good clinical practice where required, including, critically, that informed consent was obtained, freely given, and documented as required. Reviewers will be equipped to identify and escalate data-integrity concerns.