On 10 September, media outlet The New York Times reported that US authorities are considering measures against pharmaceutical products from China. The report cited a draft executive order proposing two key actions regarding US-China business development and data regulation:

First, stricter reviews of US pharmaceutical companies' acquisitions of Chinese drug candidates, including assessments by the Committee on Foreign Investment in the United States (CFIUS). Second, requiring local regulator the Food and Drug Administration (FDA) to conduct more rigorous reviews of Chinese clinical trial data while imposing higher regulatory fees on companies submitting such data.
The potential impact of enhanced cross-border transaction reviews remains unclear. Recently, more Chinese innovative drug companies have adopted transaction-driven strategies, making the industry sensitive to geopolitical fluctuations. However, some analysts suggest political manoeuvres might briefly stimulate transaction activity.

Regarding FDA recognition of Chinese clinical data, Novartis CEO Vas Narasimhan stated that the risk of halting mutual recognition of clinical data exists, but global clinical trial regional fragmentation would severely hinder drug development — the US alone cannot complete patient recruitment. He added that R&D costs would also increase for pharmaceutical companies. Thus, implementing these proposals would pose significant threats to US firms too.

Setting aside unconfirmed proposals, Chinese companies face a trend of stricter FDA reviews.
Amid global supply chain restructuring and regulatory technology upgrades, the FDA is reshaping the regulatory landscape through a set of measures that not only profoundly impact global pharmaceutical competition rules but also bring unprecedented compliance challenges to Chinese companies expanding overseas.

FDA's Stance on Overseas Clinical Data: Openness with Caution

In the widely discussed report, The New York Times reiterated the US government's push to accelerate FDA review processes. Previously, the institution proposed strategies to further speed up drug approvals, such as the Conditional National Priority Voucher (CNPV) program, but faced criticism over "cutting corners" and "politicisation of approvals".

Indeed, the FDA has sometimes prioritised speed over data volume. Two 2023 Oregon State University studies indicated FDA openness to drugs with less data. Among 37 drugs approved in 2022, 24 (65%) were approved based on a single study, while only 4 (approximately 11%) reported three or more studies pre-approval.

Patient recruitment remains challenging, as large pharma companies find US patients alone insufficient for clinical studies, forcing the FDA to become more open to overseas data.
The FDA's Drug Trials Snapshot revealed that in 2024, the FDA approved four drugs with no US participants in their trials, covering treatments for blood disorders, urinary tract infections, cancer and a rare disease. This marks an increase from two such approvals in both 2022 and 2023.
Outcomes suggest the FDA is increasingly approving drugs without US trial participants, gradually reducing absolute reliance on domestic data while accepting diverse overseas data to shorten approval timelines and meet patient needs for critical therapies.
However, for Chinese companies, the FDA maintains strict racial diversity requirements for data and growing vigilance regarding US biosecurity.

The FDA has stated it will not approve drugs based solely on China-only studies. In 2022, it issued complete response letters to Eli Lilly and Company and Innovent Biologics, requesting supplementary US patient data for sintilimab. Last year's approvals without US participants still involved trials conducted across multiple countries.

Additionally, the FDA explicitly guards against sensitive information (e.g. biometric and genomic data) access by China and other "countries of concern". For instance, in June it announced halting new studies involving sending US citizens' live cells to China or other adversarial nations for genetic engineering before reinfusion into US patients, adding it would review ongoing trials and disallow new ones.
Yet the US has not made domestic trials easier. This year's federal budget cut billions from National Institutes of Health (NIH) funding, expected to impact clinical funding nationwide. Industry sources note US firms continue actively seeking trial opportunities abroad.

Regulatory Upgrade Toughens Overseas Inspections

Beyond geopolitical factors, the FDA is rapidly advancing a comprehensive regulatory system upgrade — transitioning from "event-driven compliance reviews" to a "continuous, globalised, data-driven regulatory framework".
In recent months, the FDA has launched three major reforms leading US pharmaceutical industry transformation:
On 6 May, driven by an executive order, the FDA announced an expansion of unannounced overseas inspections to address historical "double standards" between domestic and foreign facilities.
On 26 June, the FDA issued its final guidance Conducting Remote Regulatory Assessments — Questions and Answers, formally incorporating Remote Regulatory Assessments (RRA) into its permanent regulatory toolkit.
On 10 July, as part of "radical transparency" initiatives, the FDA launched a centralised database on its public platform containing over 200 redacted complete response letters (CRL).
Additionally, the FDA officially deployed generative AI tool Elsa to assist staff in review tasks such as identifying high-priority inspection targets.
These measures demonstrate the FDA's efforts to strengthen regulatory rigour and transparency while further emphasising data integrity focus. They not only raise compliance thresholds but also reshape industry perceptions of FDA oversight — requiring companies to shift from responding to individual inspections to maintaining continuous compliance readiness.
To achieve oversight across time and location, the FDA formally integrated RRA into its regulatory toolkit and expanded unannounced overseas inspections, marking a significant step toward real-time monitoring. The RRA final guidance issued 26 June 2025 establishes RRA as a standalone permanent regulatory mechanism beyond traditional on-site inspections, applicable not only to Good Manufacturing Practice (GMP) but also clinical trial conduct under Good Clinical Practice (GCP) and all other Good Practice (GxP) related activities.
Technically, companies or manufacturing sites may refuse "voluntary" RRA without constituting direct non-compliance, but the guidance clarifies such refusal may delay FDA regulatory decision-making processes (including decisions related to pending applications) or prompt FDA to initiate traditional on-site inspections. This integrated system enables the FDA to conduct categorical assessments via remote electronic record reviews at low cost and high speed; if companies refuse RRA or provide incomplete data, the FDA may trigger unannounced inspections accordingly.
A key component of the "anytime, anywhere" regulatory framework is the FDA's increased frequency of unannounced inspections at overseas production sites. The core objectives are to require foreign manufacturers to comply with the same standards as US domestic manufacturers and more effectively expose bad actors who may falsify records or conceal violations through pre-notified inspections.
This also addresses longstanding criticisms from US pharmaceutical companies — even before the COVID-19 pandemic, the FDA faced accusations of stricter requirements for domestic firms while being more lenient with overseas companies.
Signs of tightening oversight were evident in the FDA's 2024 Fiscal Year Report on the State of Pharmaceutical Quality. Post-pandemic, FDA drug quality assurance inspections (including surveillance and for-cause inspections) increased significantly: 522 in FY2022, 766 in FY2023, and 972 in FY2024, showing year-on-year growth.

Figure 1. FDA drug quality assurance inspections by country/region from FY2019 to FY2024

In FY2024, FDA inspections of overseas sites reached a historic high, exceeding 62% of total inspections. India and China were particularly prominent: 34% of sites on India's registry and 28% of sites on China's registry were inspected. By comparison, only 24% of sites on the US registry were inspected in FY2024. 

Table 1. Proportion of sites with most recent inspection results as NAI (No Action Indicated) or VAI (Voluntary Action Indicated) by country/region as of FY2024

Historical industry practice has proven that enhanced compliance and quality requirements are a long-term passport for global competition. Current GMP inspection results reflect a site's capability to produce drugs meeting FDA quality standards. According to FDA statistics, Chinese sites' qualification rates align with global averages and even slightly exceed US rates.
In conclusion, the FDA's stricter oversight is not solely driven by short-term geopolitical fluctuations but represents a long-term trend in global pharmaceutical regulation. The FDA is evolving into a stricter, more transparent and more precise regulatory body that pushes the global pharmaceutical industry toward higher quality standards — an aspect Chinese companies can currently leverage.