Accelerate global drug development: Navigating China's evolving pharmaceutical regulatory landscape

This blog is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.

Introduction 

China’s position as one of the most significant and rapidly growing pharmaceutical markets comes with a complex, evolving regulatory environment. Through the implementation of regulatory and operational changes, this landscape is creating opportunities for pharmaceutical companies seeking to expand their global footprint.  

Recent regulatory reforms, including those announced in January 2025 by the State Council of China,¹ demonstrate China's commitment to strengthening drug and medical device regulation while promoting high-quality development within the pharmaceutical sector. 

Key regulatory reforms 

The State Council of China has implemented 24 reform measures across five strategic areas, designed to modernize the country's approach to pharmaceutical regulations: 

1. Enhanced support for R&D innovation 

• Implementation of specialized programs such as the "Pilot Plan for Encouraging the Development of Pediatric Anticancer Drugs" 
• Establishment of the Center for Drug Evaluation’s (CDE's) Rare Disease Care Program to address unmet medical needs 

2. Optimized review and approval procedures 

• Introduction of the 30-day clinical trial approval mechanism to accelerate development timelines based on 30 working days (WD) pilot program for CTA/IND performed from August 2024 to July 2025 
• Streamlined processes for innovative therapies, and rare diseases, described in more detail in the following sections 

3. Strengthened compliance through rigorous supervision 

• Application to Pharmaceutical Inspection Co-operation Scheme (PIC/s) in September 2023, demonstrated commitment to align with international standards 
• Implementation of enhanced monitoring systems 

4. Expanded international cooperation 

• Full implementation of International Council for Harmonization (ICH) guidelines 
• Exploration of segmented production models for biological products 
• Encouragement of investigator-initiated trials (IIT) 
• Provisions for domestic manufacture of products approved in foreign markets 

5. Regulatory system advancement to meet industrial development 

• Publication of "Draft Implementation Measures for Drug Trial Data Protection (Trial)" in March 2025², strengthening intellectual property protection 
• Development of frameworks balancing industrial growth with safety requirements 

Navigating the breakthrough regulatory pathways in China   

Over the years, China has also implemented several policies for innovative drug development, specifically favorable for unmet medical needs. Like approaches taken by the European Union (EU), the United States (US), and Japanese regulatory authorities, there are accelerated regulatory pathways applicable for medicinal orphan products with foreign approvals:   

*Breakthrough therapy pathway for new or improved drugs does not apply in China if the proposed indication is already approved abroad for the same product.  

In addition to accelerated assessment procedures, there are additional advantages in China: 

• Six-year data protection 
• Regulatory flexibility: potential for clinical trial waivers or reductions based on overseas data 
• Support programs: initiatives such as the CARE plan and SPARK plan, providing early communication channels and patient-centered review approaches for rare disease products 
• Financial incentives: tax exemptions and simplified VAT rates, reducing development costs 

Additionally, a premium service has been established for conditional approval and priority review projects that allow for pre-NDA face-to-face consultations with CDE in Beijing, Shanghai and Shenzhen to minimize policy/procedural and administrative issues before NDA/BLA submission.  

Strategic considerations for global-into-China market entry 

While benefiting from the process changes, companies still need a well-designed global-to-China regulatory strategy that accounts for numerous factors, including differences in regulatory requirements and cultural perspectives. Based on extensive experience in the Chinese market, Parexel experts have identified four common scenarios regarding the acceptance of foreign clinical data, each requiring specific regulatory approaches. These are discussed in detail in the webinar referenced below.  

Bridging studies represent a significant component of China market entry strategies, with approximately one-third of Parexel's regulatory consultancy projects in China involving bridging trial requirements and design considerations. These studies are essential for addressing potential ethnic factors and ensuring data relevance to the Chinese population, such as (and not limited to):  

• Safety risks for the Chinese population, especially for drugs that had safety issues in clinical trials conducted in other regions, without well-understood mechanism and/or new active ingredient  
• Body weight differences, which are substantial between Chinese and Western populations and exposure levels for the same drug dosage may differ and lead to differences in safety and efficacy 
• Metabolic differences, based on genetic polymorphism or pharmacodynamic differences that need close investigation 

Conclusion 

China's comprehensive regulatory reforms create a more supportive ecosystem for pharmaceutical development while maintaining rigorous standards. These changes present significant opportunities for global pharmaceutical companies to accelerate their development programs by leveraging China's evolving regulatory framework. Companies that successfully navigate this complex landscape, with appropriate local expertise and strategic planning, can achieve more efficient global development timelines while accessing one of the world's most important pharmaceutical markets. 

To learn more about the changes in Chinese regulatory approaches, and how those can improve your global development planning, listen the industry expert-led webinar available now on-demand. 

Watch the webinar

Connect with our team directly and leverage our extensive experience and expertise in managing clinical trials and regulatory projects globally, including China. We are always available for conversation.

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References 

1. https://english.www.gov.cn/policies/latestreleases/202501/03/content_WS6777c872c6d0868f4e8ee7cd.html 
2. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20250319181537196.html 
3. https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200708151701834.html  

Note: This information is provided for educational purposes only. It should not be construed as legal advice, and readers should not act upon this information without seeking professional advice.  

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