Overview

When China's National Medical Products Administration (NMPA) proposed halving its clinical trial review period from 60 to 30 working days in June 2025,^1,2 it crystallized a competitive dynamic in which China's pace has become an increasingly important reference point. The policy followed months of accelerating deal activity with Chinese biotechs capturing 32% of global out-licensing deal value in the first half of 2025, up from 21% across 2023–2024^3,4 reflecting a growing confidence in Chinese biotech capabilities and increased appetite for China-developed assets.

Large pharmaceutical companies are now in-licensing roughly 30% of their innovative drugs from Chinese firms,⁵ underscoring how China's regulatory efficiency has become a factor in where capital flows and how development strategy is set. These dynamics are increasingly considered in decisions about where early-stage assets first enter human trials. The central question for leadership teams is shifting: regulatory efficiency is becoming an important factor in global competition, with China's reforms having become a gravitational center for global efficiency standards.

The pattern taking shape across markets suggests alignment around efficiency standards pioneered in China rather than simple imitation. The UK's MHRA, for instance, implemented its pioneering framework for decentralized manufacturing in July 2025, allowing medicines to be produced at the point of care. While the FDA, at its June Cell and Gene Therapy Roundtable, engaged seriously with proposals to streamline early-stage trial oversight.^6-9 Though these initiatives were likely years in the making, their timing and focus are consistent with the competitive pressure generated by China's efficiency gains.

What we're witnessing is not reactive policymaking, but global convergence toward efficiency models China was among the first to operationalize at scale, as regulatory systems evolve under shared pressures of competition, cost, and complexity. In short, China's reforms seem to have become a gravitational center for global efficiency standards and a benchmark that regulators worldwide increasingly measure against.

Recent Developments Illustrate China's Benchmark Effect

Recent developments illustrate how efficiency benchmarks established in China are reshaping regulatory expectations globally, and not as direct imitation, but as responses to the competitive standard China has set.

The FDA's June 2025 Cell and Gene Therapy Roundtable marked an inflection point in this ongoing evolution. At the forum, prominent researcher Carl June proposed adopting China's two-tier regulatory system - a reform reminiscent of NMPA's efficiency-first framework - where early-stage trials require only institutional review board approval before FDA involvement. June directly stated that "The U.S. process is too slow, costly, and inflexible," as reported by GEN, and advocated for regulatory reforms aligned with China's approach.^6,7

Speakers framed the discussion around competitive urgency, with some warning of "ceding dominance" to China as researchers increasingly take trials overseas due to regulatory efficiency advantages. FDA leadership emphasized they would take the feedback seriously and that the roundtable was intended to drive tangible policy change.

The UK's MHRA represents another example of efficiency-focused reform, with a move echoing China's decentralization drive and translating regulatory flexibility into clinical reality. In July 2025, new regulations took effect allowing decentralized manufacturing of personalized medicines at point of care. This made the UK "the first country in the world to introduce a dedicated legal framework for medicines made at the point of care".^8,9 While this framework was developed over several years, its implementation reflects a global urgency around efficiency in which China has been a clear leader.

The numbers reveal growing interest in Chinese biotech assets. According to industry analysis, total deal value for Chinese biotech licensing reached approximately $51.9 billion in 2024, representing substantial year-over-year growth.¹⁰ While this growth reflects multiple factors including innovation quality and cost advantages, it seems to reflect increased confidence in Chinese development capabilities, including regulatory processes.

The Mechanics of Regulatory Competition

China's decade-long regulatory transformation has not only modernized its domestic market but helped redefine global expectations of speed, risk tolerance, and efficiency. In particular three innovations seem to be influencing regulatory discussions in major markets:

1. Objection-based approval mechanisms: Under this system, trials automatically proceed unless regulators raise specific objections within defined timeframes. China's current 60-day review period (proposed to drop to 30 days) exemplifies this presumption-of-approval approach, where silence equals consent, which is a departure from traditional burden-of-proof models.^1,2 While the FDA has similar expedited programs in rare diseases, these developed independently to address specific therapeutic needs.
2. Conditional approval pathways: These accelerated pathways accept earlier-stage clinical data for life-threatening conditions, granting market access before full efficacy proof. The NMPA has applied this approach extensively, granting 103 conditional approvals from 2020-2023, nearly 90% for oncology agents, with no publicly reported withdrawals to date.¹¹
3. Parallel review processes: Rather than waiting for trial completion, this approach begins regulatory assessment while studies are ongoing, compressing traditional sequential timelines. Combined with robust clinical infrastructure, this enables accelerated data generation that outpaces traditional development timelines, though elements of parallel review exist in Western systems but are applied less systematically.

Strategic Implications for Global Development

China's regulatory innovations are adding a new dimension to how companies approach global development strategy. While regulatory efficiency has always been a consideration, the speed differentials between markets are becoming more pronounced and harder to ignore.

This shift is most visible in how companies now approach lead market selection. China's emergence as a fast-track option has introduced a new variable into established decision-making frameworks: the possibility of using speed as a primary sequencing factor rather than market size. China approvals can increasingly serve as credibility anchors for subsequent global filings, enabling strategies that would have been impossible five years ago.

Cross-border data acceptance remains the critical enabler. Multi-regional clinical trials now routinely support Chinese approvals, enabling companies to capture China's speed advantages while building global regulatory packages.¹¹ China's conditional approval program shows no publicly reported withdrawals to date based on available data, though comprehensive post-market surveillance remains limited.¹¹

For companies considering China-first development approaches, multiple strategic questions arise. Will FDA and EMA accept Chinese clinical data for their own regulatory submissions? Do Chinese regulatory standards carry sufficient credibility for global approvals? Beyond regulatory acceptance, operational challenges include navigating different manufacturing requirements, intellectual property protection concerns, and data transfer restrictions that could complicate international development programs.

Commercial considerations also factor into strategic planning. Chinese market access requirements may conflict with global pricing strategies, and mandatory local partnerships could complicate intellectual property control. Companies must weigh China's speed advantages against these operational and commercial risks when designing global development strategies.

For investors, the question becomes: is speed becoming a leading indicator of value creation? As regulatory efficiency becomes a more prominent factor in strategic planning, these dynamics intersect with an increasingly complex geopolitical landscape.

The Policy Risk Paradox

As China's regulatory model gains global influence, geopolitical factors introduce new layers of uncertainty for strategic planning. The paradox itself stems from China's success: the more effective its model, the more others feel pressure to converge, even amid geopolitical friction.

Proposed U.S. legislation such as the BIOSECURE Act underscores growing scrutiny of China-linked biotech partnerships in Washington—creating tension between domestic security concerns and market recognition of China's regulatory advantages.^13,14

Evidence suggests market forces continue to exert strong counter-pressure against emerging political restrictions. In H1 2025, U.S. companies signed 14 China-licensed deals worth approximately $18.3 billion, compared to just 2 such deals in H1 2024—indicating that demand for China's innovation pipeline remains robust despite political tensions.¹⁵

The competitive dynamics create a dilemma for early adopters: if China's advantages prove durable, they force global convergence that eventually eliminates the advantage. If they prove unsustainable due to safety concerns, early adopters face reputational and financial risks.

Standard harmonization pressure creates both opportunity and risk. As efficiency becomes a competitive necessity globally, China's current advantages represent what may be a transitional benefit in a world moving toward China-level efficiency standards. The strategic question for companies: how to balance capturing short-term speed advantages against building sustainable long-term strategies?

Global Regulatory Competition Intensifies

Regulatory agencies worldwide face mounting pressure to achieve efficiency standards similar to China's while maintaining safety standards. This pressure will likely intensify, not diminish.

China's proposed reduction to 30-day clinical trial reviews would establish a new benchmark for regulatory speed globally.^1,2 Meanwhile, the MHRA's point-of-care manufacturing framework represents a significant regulatory adaptation, allowing bedside production of personalized medicines—demonstrating how agencies are pursuing efficiency through different approaches to oversight.

The market data supports China's continued pace-setting role. According to Jefferies analysis, Chinese biotechs have developed 639 first-in-class drug candidates since 2022. This represents a 360% increase from 2018-2021 - significantly outpacing development rates in other primary markets.³ Such a robust drug development pipeline reinforces China's position as a significant player in global drug development, intensifying competitive pressures across markets.

For companies navigating this landscape, the central questions become: Do China's speed advantages justify the operational complexity and geopolitical risks? And if competitors are gaining time-to-market advantages through China-first strategies, can we afford not to follow?

Companies that ignore regulatory efficiency trends may find themselves at a competitive disadvantage as speed-to-market becomes increasingly important. Those that adapt their global development strategies to account for varying regulatory timelines across markets will be better positioned to compete effectively.

Regulatory efficiency is emerging as a more prominent factor in global drug development strategy. Companies will need to adapt their development planning to account for varying speeds across regulatory systems, balancing efficiency opportunities against operational complexity and geopolitical considerations.

Success in this evolving landscape requires sophisticated understanding of regulatory pathways across multiple markets and the flexibility to adjust strategies as both competitive dynamics and geopolitical factors continue to shift.