n the rapidly evolving global pharmaceutical research and development landscape, China is transitioning from harmonization with international standards to becoming a vital innovation engine.

ICH: Accelerating China’s Global Integration

China’s implementation of ICH guidelines has significantly amplified the internationalization of China’s pharmaceutical regulation, spurred alignment with global standards, and streamlined the synchronized research and development (R&D) and overseas launch of innovative drugs. The review clock for innovative-drug Investigational New Drug applications in China has been compressed from 14 months in 2012 to a median of 30 working days in 2023, a reduction of more than 90%.

Since joining ICH in 2017, China’s National Medical Products Administration (NMPA) has fully adopted all 71 ICH guidelines and aligned its regulatory framework with global standards. This integration has not only boosted international confidence in Chinese drug quality but also strengthened China’s voice in global rule-making through participation in 45 ICH working groups, and accelerated overseas expansion of China-originated drugs: Zanubrutinib and benvitimod obtained rapid back-to-back approvals from the NMPA and US Food and Drug Administration (FDA) using an identical, ICH-compliant global data set, underscoring the seamless acceptability of China-generated evidence to major regulatory authorities. NMPA continues to optimize the review and approval of clinical trials, especially for innovative drugs: After the 2024 “30-day pathway” pilot (in Chinese), this benchmark was formalized on 12 September 2025 when NMPA codified the 30-working-day clinical-trial authorization route.

China as a Clinical Trial and Innovation Powerhouse

In 2024, Chinese companies initiated 39% of global oncology clinical trials—the highest share worldwide—while contributing around one-third of the global new drug pipeline, cementing China’s status as an innovation hub. To sustain this momentum, experts emphasize the imperative need for early integration of global patient needs, multiregional data, and proactive engagement with global agencies like the FDA and European Medicines Agency (EMA). Leveraging partnerships with globally experienced contract research organizations (CROs) is also vital. Ultimately, achieving success requires a sharp focus on a drug’s distinct value proposition and the unmet medical needs it addresses, going beyond simply replicating existing approaches. While cultural challenges remain, they can be addressed through targeted strategies.

For instance, both China-originated toripalimab and tislelizumab obtained FDA approval by actively engaging with the agency and utilizing available data, despite travel restrictions and other COVID-19 challenges that delayed the review process. This collaboration enabled the necessary inspections and underscored the importance of these therapies for unmet medical needs in oncology. An increasing number of successful instances of simultaneous application and/or approvals in both the US and China (e.g., KY-0301) highlight the trend of global drug codevelopment and synchronized submissions.

AI Reshaping Drug Development

AI has emerged as the undisputed cornerstone of future R&D in China, reframed not merely as isolated tools but as intelligent ecosystem cores. AI has evolved from automating tasks to driving systemic efficiencies. Recent research reveals AI’s potential to significantly reduce clinical trial database lock times and improve patient recruitment efficiency. However, unleashing AI’s full potential requires high-quality data, robust governance, and transparent model validation. Regulators emphasize the need for international guidelines to ensure AI is used ethically and effectively in healthcare, and existing guidance from the FDA, EMA, and NMPA can serve as references.

Collaborative Ecosystems and Future Challenges

Even after all this progress, key challenges remain for advanced therapies (ATMPs), such as regulatory complexity and manufacturing costs, which call for early partnerships with contract development and manufacturing organizations (CDMOs) and innovative reimbursement models to collaboratively overcome. To tackle the regulatory challenges, NMPA has issued a series of guidance documents (Draft for Comment) for ATMP since 2024 (Scope, Classification, and Interpretation of ATMPs, Detailed Rules for the Application and Management of Type I Meetings in Communication and Exchange for ATMPs) to aim at establishing a clear registration pathway.

Cultivating hybrid talent—skilled in AI, data science, and cross-border collaboration—is also essential for future success (see related article). As outlined in the Blue Book Opportunities and Challenges for International Talent in China’s Innovative Pharma Companies’ Global Expansion, published at the Talent Forum, China’s global aspirations hinge on its “5H” leadership paradigm: Heart (empathy), Horizon (insight), Head (execution), Hand (entrepreneurship), and Health (resilience).

Conclusion: A New Era of Collaborative Innovation

China’s success in helping to meet the world’s healthcare needs—from mainstream medicines to advanced therapies—will hinge on sustained cross-border collaboration, grounded in regulatory harmonization, data-driven rigor, and cultivating adaptable talent. The path forward demands flexibility, continuous learning, and unwavering international cooperation.