Regulatory Framework & Approval Process

Q: What is the regulatory pathway for international biotechs to conduct clinical trials in China?

A: International biotechs must submit an Investigational New Drug (IND) application to China's National Medical Products Administration (NMPA) through the Center for Drug Evaluation (CDE). The process includes preclinical data submission, clinical trial protocols, and manufacturing information. The NMPA follows a "default approval" system where applications are automatically approved if no objections are raised.

Q: How long does the IND approval process typically take?

A: The standard timeline is 60 calendar days from submission. However, for innovative drugs, multi-regional clinical trials (MRCTs), rare diseases, advanced therapies, and breakthrough therapies, the approval timeline can be accelerated to as fast as 30 days. If the CDE requests additional information or clarification, the clock stops until responses are provided. Well-prepared applications often receive approval within the accelerated timeframe when eligible for fast-track pathways.

Q: Can we use foreign clinical data to support our China IND application?

A: Yes, China accepts high-quality foreign clinical data, including data from FDA or EMA-approved studies. This can significantly accelerate the development timeline and reduce duplicate studies.

Q: What are the key differences between China's regulations and FDA/EMA requirements?

A: China's regulations are increasingly harmonized with ICH guidelines. Key differences include specific requirements for Chinese population pharmacokinetic studies for certain drug classes, local manufacturing considerations, and unique post-market surveillance requirements.

Clinical Trial Design & Execution

Q: Do we need to conduct separate bridging studies for the Chinese population?

A: Not always. The requirement depends on the drug class, mechanism of action, and available data. Small molecules with well-characterized pharmacology may not require bridging studies, while biologics or drugs with ethnic sensitivity considerations may need population-specific data.

Q: Can we run global multi-regional clinical trials (MRCTs) that include China?

A: Absolutely. China actively encourages participation in global MRCTs. These trials can support simultaneous global regulatory submissions and are often the most efficient approach for international biotechs. GCP ClinPlus has supported 120+ MRCTs since 2003.

Q: What patient populations and disease areas are most accessible in China?

A: China offers access to large, treatment-naïve patient populations across oncology, rare diseases, CNS disorders, ophthalmology and metabolic diseases. The country has particular strengths in hepatitis B, liver cancer, gastric cancer, and various rare diseases with higher prevalence in Asian populations.

Q: How do we ensure clinical trial quality and data integrity?

A: China follows GCP guidelines aligned with ICH standards. Choose experienced local CROs with international quality systems, implement robust monitoring plans, and conduct regular audits. Many global CROs have established local operations with international quality standards.

Regulatory Strategy & Compliance

Q: Can we use the same protocol approved in the US/EU for China trials?

A: Often yes, with minor modifications. Protocols may need adjustments for local regulatory requirements, standard of care differences, or population-specific considerations, but major design changes are typically not required.

Q: What are the requirements for local manufacturing or importation of study drugs?

A: Study drugs can be imported with proper import licenses, or manufactured locally under GMP conditions. Import requirements include drug registration certificates, import licenses, and customs clearance procedures. Many international biotechs successfully import study drugs for clinical trials.

Q: How do intellectual property protections work for clinical trials in China?

A: China has strengthened IP protections significantly. Clinical trial data is protected under data exclusivity provisions, and patent protections are enforced. However, it's advisable to file patents early and work with experienced IP counsel familiar with Chinese regulations.

Operational Considerations

Q: What are the typical costs for conducting clinical trials in China compared to other regions?

A: Clinical trial costs in China are typically 50-80% lower than US/EU, with significant savings across all operational areas:

Cost Advantages:

· Site fees and investigator payments: 60-70% lower

· Patient recruitment and retention: 40-60% lower

· Regulatory and operational oversight: 50-70% lower

· Overall program costs: 50-80% reduction vs. Western markets

Quality Assurance: These cost savings don't compromise quality. Leading Chinese CROs like GCP ClinPlus maintain global GCP standards with 100% audit pass rates from sponsors and regulatory authorities, ensuring data meets FDA, EMA, and NMPA requirements.

Value Optimization: The combination of lower costs and faster recruitment (often 2-3x faster than US/EU) provides exceptional value for international biotechs looking to optimize their development budgets while maintaining regulatory-grade quality.

Q: How challenging is patient recruitment in China?

A: Patient recruitment in China is significantly more efficient than most Western markets, with established CROs offering substantial advantages:

Recruitment Speed: Patient enrollment is typically 2-3x faster than US/EU markets due to large patient populations, centralized healthcare systems, and strong physician-patient relationships.

Network Effects: CROs with deep local expertise like GCP ClinPlus leverage extensive networks of KOLs and research sites built over decades. With 22 years of experience and relationships with 80% of oncology specialty hospitals, such networks provide preferential access to patients and investigators.

Competitive Advantage: In China's increasingly competitive clinical trial landscape, having established relationships with investigators becomes crucial. When multiple studies compete for the same patient population, CROs with strong investigator relationships can secure faster enrollment and principal investigator attention.

Site Selection: Access to 50+ partner medical centers and streamlined site startup processes can reduce site activation time by 30% compared to industry benchmarks.

The key success factor is working with CROs that have built long-term relationships with the clinical research community rather than those operating on transactional relationships.

Q: What language and cultural considerations should we be aware of?

A: All regulatory submissions must be in Chinese, requiring certified translations. Cultural considerations include different informed consent processes, family involvement in medical decisions, and varying attitudes toward clinical trial participation. Working with experienced local teams is essential.

Q: Do we need a local legal entity to conduct clinical trials?

A: No, establishing a local legal entity is not required at all, even for complex studies like cell & gene therapy trials (which previously required local partnerships until the end of 2024). International sponsors can work through qualified CRO partners who provide comprehensive one-stop services from IND application through NDA submission. A reliable CRO partner like GCP ClinPlus can handle all regulatory interactions, site management, and operational requirements without the need for sponsors to establish their own legal presence in China.

Partnership & Service Providers

Q: Should we work with local CROs or international CROs with China operations?

A: While both options exist, working with a CRO that has deep local expertise and established relationships is crucial for success in China's competitive clinical trial environment. Local CROs like GCP ClinPlus offer significant advantages:

Deep Local Networks: Established relationships with key opinion leaders (KOLs) and premier research sites enable faster site activation and preferential patient enrollment. When multiple competing studies target the same patient population, these relationships become critical for recruitment success and gaining principal investigator attention.

Regulatory Expertise: Local regulatory teams that are fluent in both English and Chinese regulatory requirements can navigate both NMPA pathways and global standards. They understand fast-track mechanisms, accelerated review pathways, breakthrough therapy designations, and local incentives that can significantly reduce development timelines.

Site Selection & Management: Local CROs have intimate knowledge of site capabilities, patient populations, and regional healthcare systems, enabling optimal site selection and efficient operations.

Cultural Understanding: Deep cultural insights and established trust with investigators facilitate smoother trial conduct and problem resolution.

The key is choosing a CRO such as GCP ClinPlus that combines local expertise with international quality standards, rather than one that simply has a local office.

Q: What regulatory consulting services do we need?

A: Key services include regulatory strategy development, IND preparation and submission, ongoing regulatory correspondence, and commercial pathway planning. Experienced regulatory consultants can navigate complex requirements and accelerate timelines through various fast-track mechanisms:

Strategic Pathway Selection: Identifying optimal regulatory pathways including breakthrough therapy designations, orphan drug pathways, and accelerated review programs that can reduce approval timelines from 60 days to as fast as 30 days.

Regulatory Intelligence: Understanding evolving NMPA policies, leveraging government incentives, and positioning for priority review programs.

Global Integration: Ensuring China regulatory strategy aligns with FDA/EMA requirements for seamless global development programs.

NDA Preparation: End-to-end support from IND through NDA submission, including regulatory defense and agency meetings.

Choose regulatory partners with proven track records in both domestic and international submissions who can provide bilingual support and understand both local and global requirements.

Q: How do we ensure compliance with both Chinese regulations and international standards?

A: Work with service providers experienced in both regulatory environments, implement dual oversight systems, and maintain regular communication between global and local teams. Many successful international biotechs establish clear governance structures bridging both systems.

Commercial Considerations

Q: How does conducting clinical trials in China affect our global commercial strategy?

A: Clinical trials in China can accelerate global development timelines, provide access to unique patient populations, and position you for the world's second-largest pharmaceutical market. Data from China trials is increasingly accepted by global regulators.

Q: What are the pathways for eventual market access in China?

A: Successful clinical trials in China provide a pathway for New Drug Applications (NDA) to the NMPA. China offers various accelerated approval pathways for innovative drugs, including breakthrough therapy designations and priority review processes.

Q: Can we leverage government incentives or funding programs?

A: Yes, various local and national programs support innovative drug development, including tax incentives, grants, and fast-track approvals for breakthrough therapies. These programs can significantly reduce development costs and timelines.

HGRAC Requirements for Clinical Trials in China

Q: What is HGRAC, and why is it relevant to clinical trials?

A: HGRAC oversees the collection, use, and export of human genetic resources (HGR), which include biological samples (e.g., whole blood, tissues, cells) and associated genetic data derived from Chinese nationals. International collaborations involving HGR require approvals to comply with China’s Biosecurity Law and HGR Regulations 210.

Q: What materials require HGRAC approval?

· A: Regulated as HGR: Whole blood, tissues, semen, cerebrospinal fluid, patient-derived xenografts (PDX), and hair with follicles 24.

· A: Exemptions: Serum, plasma, urine, feces, commercial cell lines (e.g., immortalized cell lines), and cell-derived xenografts (CDX) if they contain minimal genetic material 2410.

Q: When is HGRAC approval needed?

A: Approval is required if:

· Foreign entities or foreign-controlled Chinese entities (e.g., WFOEs, certain joint ventures) collaborate with Chinese partners to use HGR for research.

· HGR materials or data are transferred out of China 410.

· Exemptions: Clinical trials conducted solely in China for local drug approvals (only a filing is needed) or if foreign involvement is limited to funding/EDC services without data access 25.

Q: How long does HGRAC approval take?

A: The process typically takes ~1 month. Steps include online pre-review (5 business days), paper dossier submission, expert review (20 business days), and final approval 

Q:  What documents are required for HGRAC applications?

A: Key components include:

· Research cooperation agreement (with Chinese partner).

· Ethics committee approvals (from both foreign and Chinese institutions).

· Sample/data management plan (storage, disposal, security measures).

· Informed consent forms (specific to HGR use).

· Project description (objectives, methodologies) .

Q:  Are there special rules for international collaborations?

A: Foreign entities must partner with a Chinese institution (e.g., hospital, CRO) to access HGR.Data sharing with foreign parties is permitted only after approval.

Q: What are the penalties for non-compliance?

A: Violations (e.g., unauthorized export or use of HGR) can result in fines, project termination, or criminal liability under the Biosecurity Law.

Recent regulatory updates to note:

· Since May 2024, oversight shifted from MOST to the National Health Commission (NHC), aiming to streamline processes.

· The NHC clarified exemptions for minimal-risk samples (e.g., plasma) and simplified approvals for small-scale collections (<10,000 samples).

Practical tips for biotechs:

· Start early: Factor in HGRAC timelines (1 month) during trial planning.

· Engage local partners: Chinese CROs (e.g., GCP ClinPlus) can expedite approvals.

· Monitor changes: The NHC is expected to further relax rules for cross-border data flows in free trade zones (e.g., Shanghai FTZ whitelist).

Submitting Safety Reports to China CDE in Chinese

Q:  Does the China CDE require safety reports to be submitted in Chinese?

A: Yes. The Center for Drug Evaluation (CDE) mandates that all safety reports (e.g., SUSARs, DSURs, PSURs) and pharmacovigilance documents for clinical trials in China must be submitted in Chinese (simplified characters). English-only submissions are not accepted .

Q:  What types of safety reports are affected?

· Individual Case Safety Reports (ICSRs): SUSARs (Suspected Unexpected Serious Adverse Reactions).

· Aggregate Reports: DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports).

· Risk Management Plans (RMPs) and post-marketing safety updates .

Q:  How should international biopharmas prepare Chinese-language reports?

A: Work with a local Chinese partner (e.g. GCP ClinPlus) to draft reports directly in Chinese.

· Key Requirements:

o Ensure accuracy of medical terminology (e.g., adverse event names, lab data).

o Include Mandarin translations of all patient narratives (if applicable).

o Follow CDE’s templates for structured data fields .

Q:  Are there exceptions for English submissions?

A: No. Even global studies with China as a subset site must submit safety data to CDE in Chinese. However:

· Initial filings (e.g., IND applications) may include bilingual documents, but safety updates must be Chinese-only.

· References to global data (e.g., in DSURs) can cite English sources but require a Chinese summary .

Q:  What are the timelines for submission?

· SUSARs: Must be submitted to CDE within 15 calendar days (fatal/life-threatening) or 7 days (for expedited reports).

· DSURs/PSURs: Annual submissions, aligned with the global schedule but translated into Chinese .

Q:  How to ensure compliance with CDE’s format requirements?

· Use the CDE’s Electronic Submission Gateway (ESG) for digital submissions.

· Follow the ICH E2B(R3) format for ICSRs, but ensure all fields are Mandarin-compliant.

· For DSURs, include a Chinese synopsis (1–2 pages) even if the main report references English data .

Q:  What are the risks of non-compliance?

· Delays in approvals (e.g., clinical trial pauses, NDA rejections).

· Fines or penalties under China’s Drug Administration Law (Article 125).

· Reputational damage with CDE, which may affect future submissions .

GCP ClinPlus is a leading clinical CRO headquartered in Beijing, China. With a proven track record of serving 500+ global clients across 2200+ projects including 120+ MRCTs, GCP ClinPlus offers comprehensive clinical development services with 22 years of experience, 100% audit pass rates, and deep relationships across China's clinical research ecosystem. For personalized guidance tailored to your therapeutic area and development stage, contact our international business development team at suling.zhang@gcp-clinplus.com.