The continuous stream of drug approvals by Chinese pharmaceutical companies should be a source of awe to any global innovation investor. There are multiple reasons that have led to the current point. However, one key contributor is China’s drug approval policy transformation, which is one of the most under-discussed and massively impactful policy narratives of our era.
The history of the global pharmaceutical industry has largely been a monologue, spoken by the West and listened to by the East. For the better part of the post-war era, the United States, through the engines of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), served as the world’s laboratory.
In this established orthodoxy, which also included a handful of companies from Japan and Europe, China entered decades later, becoming the world’s factory. In the first phase, it became a massive but fundamentally replicative engine designed to produce volume rather than value.
This dynamic was underpinned by a regulatory lag so severe that it functioned as a non-tariff trade barrier; drugs invented in Cambridge or Basel would typically arrive in Beijing or Shanghai five to seven years after their Western debut.
This delay, known colloquially as the “drug lag,” effectively imposed a “China-last” penalty on the world’s largest aging demographic, rendering the Chinese patient population a secondary consideration in the global R&D calculus.
That era is demonstrably over. It did not end with a whimper, nor was it the result of a slow, organic drift of market forces. It ended with a calculated, statutory, and industrial restructuring of the Chinese state’s relationship with biology.
We are currently witnessing the results of a decade-long project of Acceleration by Design, a deliberate strategy to transform the regulatory review process from a discretionary gatekeeping function into a mandatory conveyance system for innovation.
The data emerging from 2024 and early 2025 confirms a tectonic inversion in the global biopharmaceutical hierarchy. For the first time in history, the sheer velocity and volume of China’s regulatory apparatus have not merely caught up to Western standards but, in specific metrics of efficiency and output, have bypassed them.
In 2024, China’s NMPA approved 83 new drugs (excluding TCM), a 12% year-on-year increase—significantly outpacing the FDA’s 50 novel medicines. Of these, 46 were Class 1/1.1 innovative drugs (the regulatory classification for drugs not previously marketed anywhere), while 48 qualified as first-in-class by mechanism of action, covering high-complexity modalities including bispecific antibodies, ADCs, and novel small molecules.
Average review times collapsed from 663 days in 2017 to approximately 105 days in 2024, an 84% reduction.
This report serves as a deep-dive forensic audit of this transformation. By verifying internal regulatory documents and synthesizing external market data, we dissect the seven structural pillars of the “Accelerationist State” and project the consequences of a world where the East no longer waits for the West’s medicine.
Acceleration by design: speed as a Legal obligation
The decisive institutional shift in China’s pharmaceutical regulatory system occurred in 2018–2019 with the revision of the Drug Administration Law.
Adopted by the Standing Committee of the National People’s Congress on August 26, 2019 and effective December 1, 2019, this reform marked the most comprehensive revision since the law’s original enactment in 1984. What distinguished this reform from incremental improvements elsewhere was structural: expedited regulatory pathways were embedded directly into statute, not left to agency discretion.
In contrast to the United States and the European Union, where accelerated approval and fast-track mechanisms remain largely discretionary and subject to negotiation, China codified these mechanisms through legally binding timelines, explicit caps on standard review durations, and mandatory statutory review periods, including the 60-day silent approval provision for clinical trial applications.
These legal changes were consequential because bureaucratic systems tend to operate at the pace they are institutionally compelled to maintain. Once review timelines were enshrined in law, delay was reclassified from an expression of regulatory caution to a form of non-compliance. Expedited review shifted from an exceptional privilege to the default regulatory mode.
The share of expedited approvals rose from effectively zero in 2017 to over 90% by 2024.
Sources: NMPA official announcements; CDE Annual Reports; FDA CDER Novel Drug Approvals; Nature Reviews Drug Discovery
The trajectories are diverging. FDA review times have lengthened to 356 days in 2024, driven by structural complexity (a record 32 percent of approvals were complex biologics), multi-cycle reviews under a post-Aduhelm safety-first stance, and ongoing global inspection backlogs.
The dip to 37 approvals in 2022 reflected a post-pandemic “administrative debt” that has not fully cleared. Meanwhile, China’s system has institutionalised acceleration as its default operating mode.
60-day clock and silent approvals
Behavioral economists have long understood that defaults shape outcomes more powerfully than preferences. The seminal 2003 organ-donation study by Johnson and Goldstein found that opt-out countries achieved donation rates above 90% while opt-in countries with similar cultural attitudes languished below 20%. China’s 60-day silent approval mechanism applies this logic to drug regulation: inaction by the regulator results in approval, not delay.
A key but often misunderstood contributor to China’s accelerated clinical development timelines is the way the statutory 60-working-day IND review clock is applied in practice. Under the baseline regulatory framework, the NMPA’s Centre for Drug Evaluation has 60 working days to raise objections to a submitted IND.
If no objections are issued within this period, the clinical trial may proceed automatically, the so-called silent approval mechanism. This structure is broadly analogous to the FDA’s 30-day IND clock, although it is longer on paper.
In practice, the effective review period is routinely compressed through pre-clearance and prioritization mechanisms. Pre-IND scientific consultations with CDE reviewers address core issues such as toxicology adequacy, starting dose, and trial design in advance. The subsequent IND is submitted in line with prior agreement, typically resulting in no substantive review questions.
This allows clinical trials to commence within days rather than months. For prioritized programs, INDs may be processed through implied consent and expedited internal routing, including early assignment to senior reviewers and parallel assessment of safety and CMC components. These practices ensure that objections are identified early and many applications are cleared within one to three weeks.
Source: CDE 2022 Annual Report; regulatory science literature
China’s regulatory modernization rests on four expedited pathways that mirror, yet distinctively diverge from, their FDA counterparts. Priority Review, the workhorse of the system, mandates a 130-working-day timeline and was utilised by 17 of the 48 first-in-class drugs approved in 2024.
Breakthrough Therapy Designation, applied with greater aggression in early-stage trials than its American model, guided 13 innovative drugs through rolling submissions that allow module-by-module review as data is generated, rather than requiring a complete dossier.
Conditional Approval has become the default for oncology and rare diseases, with 11 drugs reaching market in 2024 based on surrogate endpoints rather than overall survival data—a deliberate trade of evidentiary uncertainty for patient access. Special Approval compresses timelines further to 70 days for public health emergencies and strategic needs.
These pathways are no longer exceptional privileges; expedited designation exceeded 90 percent of novel drug approvals in 2024. The “China speed” phenomenon is not an artifact of lax standards but of procedural engineering. By legislating timelines, the state stripped the regulator of the ability to delay without cause, forcing the bureaucracy to innovate its own internal workflows to remain compliant with the law.
Capacity scaled before speed demanded
The most consequential reform may have been the most unglamorous: China rebuilt its regulatory capacity before demanding speed from it. Most jurisdictions pursue acceleration first and scramble to add capacity later. China inverted this sequence.
Between 2014 and 2024, the Centre for Drug Evaluation expanded its workforce from fewer than 200 reviewers to over 1,300 full-time staff, a 550% increase. The recruitment was not merely quantitative. CDE actively recruited PhDs from US and EU biopharma, bringing deep domain expertise alongside raw throughput.
Dedicated fast-track teams were established for breakthrough therapy designations and conditional approval applications. The structural reorganisation mattered as much as the headcount. The original four generic divisions, covering chemistry, pharmacology and toxicology, clinical assessment, and general affairs, gave way to twelve specialized centers organized by therapeutic area.
CAR-T products are now reviewed by dedicated Cell and Gene Therapy teams, achieving decision times under 60 days. The AI and Digital Biomarkers unit, established in 2022, specifically supports AI-discovered drug candidates from companies like Insilico Medicine and XtalPi.
Sources: CDE Annual Reports 2017–2024; NMPA official statistics; Therapeutic Innovation & Regulatory Science
The parallel review mechanism allowed clinical, CMC, and toxicological assessments to proceed concurrently rather than sequentially. The e-Submission platform launched in 2019. Rolling review adoption now covers more than 80% of novel drugs. Only when this capacity infrastructure was operational did speed become a realistic objective rather than a political aspiration.
China removed the “China-last” penalty
Prior to 2018, China’s pharmaceutical regulatory system was structurally slow, in part because it required repetitive studies for each new drug. These requirements often included duplicated toxicology assessments, Phase I clinical trials, and manufacturing validation, even when comparable studies had already been conducted elsewhere.
Following China’s accession to ICH as a regulatory member in June 2017, a series of reforms enabled the acceptance of foreign clinical and preclinical data. Global clinical trials were formally permitted, enabling parallel China-global development rather than sequential entry.
The acceptance of foreign data is generally stratified into three categories. Data are fully accepted when they are reliable, comply with ICH Good Clinical Practice, and show no significant ethnic sensitivity affecting safety or efficacy in Chinese patients.
Data are partially accepted when they are reliable but indicate potential ethnic differences or insufficient local evidence, typically requiring a smaller bridging study in China. Data are not accepted when they are unreliable, non-compliant with ICH GCP, or show substantial ethnic differences that prevent extrapolation to Chinese populations.
Together, these changes transformed drug development from a sequential US to EU to China pathway, which often took years, into a simultaneous China-global approach. The number of Chinese-origin drugs included in global multi-regional clinical trials has grown exponentially since 2018, from just 2 drugs during 2015–2017 to 48 during 2018–2024.
Chinese-only trials have historically faced acceptance challenges abroad. The FDA’s concerns about single-country data and population-relevance requirements have created friction for drugs developed without multi-regional representation. China’s policy response was not to fight these barriers but to render them less consequential.
By expanding MRCT participation from 2 drugs during 2015–2017 to 48 during 2018–2024, Chinese innovators gained access to global trial infrastructure. More critically, the acceleration of domestic approvals means Chinese companies can now secure home-market approval first, generating revenue, real-world evidence, and clinical credibility while global registration proceeds in parallel.
A two-to-three-year lead time in a market of 1.4 billion patients is not a consolation prize, but a strategic asset. As was the case with many electronic gadgets in North Asia, early launches in home markets serve as laboratory test cases before global launches.
Incentives aligned end-to-end
China’s transition from a generics-dominated to an innovation-driven pharmaceutical ecosystem reflects a coordinated, end-to-end incentive architecture rather than isolated regulatory reforms. This framework synchronised regulatory, reimbursement, pricing, financial, and manufacturing policies to de-risk and reward high-value research and development, creating conditions conducive to sustained innovation.
At the regulatory layer, the NMPA reduced median new drug review times from 28 months in 2015 to under six months for Priority Review designations by 2024. At the reimbursement layer, the National Reimbursement Drug List introduced fast-track inclusion pathways whereby breakthrough therapies could achieve national insurance coverage within 6–12 months of approval.
At the pricing layer, the Volume-Based Procurement programme, while highly price-eroding for generics, explicitly exempted Class 1 innovative drugs for the first five years post-approval, preserving premium pricing and return on investment.
At the capital layer, state-backed funds co-invested alongside private venture capital, with biotech venture funding increasing from US$2.1 billion in 2017 to a peak between $15.7 billion and $19.3 billion in 2021 before correcting to approximately $7.3 billion in 2024. At the manufacturing layer, the growth of high-GMP domestic CDMOs such as WuXi Biologics, Pharmaron, and JHL Biotech eliminated production bottlenecks.
Together, these aligned policies transformed innovation from a high-risk, low-return activity into a financially viable, commercially protected, and strategically rewarded endeavour, fundamentally reshaping the trajectory of China’s biopharmaceutical industry.
AI as sovereign infrastructure
While Western regulators debate the explainability of artificial intelligence in drug discovery, China has moved to treat AI as essential infrastructure. The inflection point was the CDE’s 2022 “Technical Guidelines for the Use of AI in Drug R&D,” which did what the FDA has hesitated to do: provide binding rules for how AI-generated data can support an IND submission.
The guidelines accept AI for target identification, molecule design, and pharmacokinetic prediction, require audit trails of inputs and outputs rather than demanding full algorithmic transparency, and establish specific validation standards for AI-predicted toxicity. This regulatory certainty reduced translational friction—AI-native biotechs no longer had to guess whether their data would be accepted.
The validation came in 2024–2025 when Insilico Medicine reported positive Phase IIa results for rentosertib, a drug for idiopathic pulmonary fibrosis that was entirely discovered and designed by AI—target, molecule, and development candidate.
This represents the first concept-to-clinical-proof validation of generative AI in drug discovery, and it occurred in China not merely because of the technology but because the regulatory environment permitted a rapid transition from in silico models to human trials.
Behind this sits a broader national project: petaFLOPS-scale supercomputing hubs in Hong Kong and Shanghai, centralized medical data aggregation via the National Medical Data Center, and data-export safe harbors that address the data-hungry needs of AI models.
While the US struggles with fragmented healthcare data across HIPAA silos, China is building the full stack from compute to algorithm to molecule.
Regulations aligned for the innovation era
The staggering pace of China’s pharmaceutical emergence has multiple drivers that we will cover in future pieces. But of all, the regulatory dimension has received insufficient attention.
The contrast with global Big Pharma is stark: while Western giants haemorrhage value to patent cliffs, agonize over pipeline gaps, and endure review timelines stretching toward a year, Chinese innovators operate within a system explicitly engineered to compress time-to-market.
This was not accidental. Senior policymakers framed dependence on foreign pharmaceuticals as a national security vulnerability and embedded regulatory reform within a coordinated state strategy spanning healthcare, industry, and science ministries. The result is a system where speed is not a privilege to be requested but an obligation to be met.
Purists will rightly worry about the risks of acceleration. Faster approvals will inevitably lead to more conditional authorisations, greater reliance on surrogate endpoints, and increased pressure on post-market surveillance. Some drugs that reach patients will later disappoint. But this critique misses the larger context.
In a generative AI era where drug discovery is accelerating and where computational pipelines generate candidates faster than traditional systems can evaluate them, regulatory velocity becomes a binding constraint. Chinese regulations position local companies to operate at the tempo the technology now permits.
The evidence is visible in quarterly announcements: Chinese biotechs are advancing clinical programs, securing approvals and executing licensing deals at a cadence that makes Big Pharma’s pipeline updates read like dispatches from a slower era.
The competitive dynamics compound this advantage. China’s domestic market is hypercompetitive. Dozens of companies are racing across overlapping therapeutic targets, compressing margins, and forcing relentless cost discipline.
This brutality is a feature, not a bug. It ensures that Chinese innovators retain the cost leadership that once defined the country’s generics industry, now applied to novel biologics and first-in-class mechanisms. When a Chinese bispecific reaches global markets, it arrives battle-tested on price.
If Chinese companies are yet to achieve a defining global win, a first-in-class blockbuster that reshapes a therapeutic category worldwide, the infrastructure for such a win is now operational. Capacity has been built. Incentives are aligned. Speed has been codified. The question is no longer whether China can innovate in the pharmaceutical industry.
It is whether legacy systems elsewhere can adapt to a world where China-first is increasingly the competitive default.
Archisha Mukherjee interned at GenInnov; Sidharth Mishra and Adit Mathew provided the guidance