Question 1

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

Accepted Answer

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.

Question 2

How long does the IND approval process typically take?

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

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

Accepted Answer

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.

Question 6

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

Accepted Answer

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.

Question 7

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

Accepted Answer

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.

Question 8

How do we ensure clinical trial quality and data integrity?

Accepted Answer

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.

Question 9

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

Accepted Answer

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.

Question 10

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

Accepted Answer

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.

Question 11

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

Accepted Answer

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.

Question 12

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

Accepted Answer

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.

Question 13

How challenging is patient recruitment in China?

Accepted Answer

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.

Question 14

What language and cultural considerations should we be aware of?

Accepted Answer

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.

Question 15

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

Accepted Answer

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.

Question 16

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

Accepted Answer

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.

Question 17

What regulatory consulting services do we need?

Accepted Answer

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.

Question 18

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

Accepted Answer

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.

Question 19

What are the pathways for eventual market access in China?

Accepted Answer

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.

Question 20

Can we leverage government incentives or funding programs?

Accepted Answer

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.

Question 21

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

Accepted Answer

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.

Question 22

What materials require HGRAC approval?

Accepted Answer

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.

Question 23

When is HGRAC approval needed?

Accepted Answer

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.

Question 24

How long does HGRAC approval take?

Accepted Answer

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.

Question 25

What documents are required for HGRAC applications?

Accepted Answer

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).

Question 26

Are there special rules for international collaborations?

Accepted Answer

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.

Question 27

What are the penalties for non-compliance?

Accepted Answer

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).

Question 28

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

Accepted Answer

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.

Question 29

What types of safety reports are affected?

Accepted Answer

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.

Question 30

How should international biopharmas prepare Chinese-language reports?

Accepted Answer

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

Key Requirements:

Ensure accuracy of medical terminology (e.g., adverse event names, lab data).
Include Mandarin translations of all patient narratives (if applicable).
Follow CDE’s templates for structured data fields.

Question 31

Are there exceptions for English submissions?

Accepted Answer

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.

Question 32

What are the timelines for submission?

Accepted Answer

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.

Question 33

How to ensure compliance with CDE’s format requirements?

Accepted Answer

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.

Question 34

What are the risks of non-compliance?

Accepted Answer

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.

Question 35

What is a CGT IIT in China?

Accepted Answer

In China, CGT IITs are investigator-initiated trials typically conducted at leading hospitals. They are often used for early-stage exploration of new indications or treatment regimens using stem cells, CAR-T, or other CGT products. These trials fall under the regulatory purview of the National Health Commission (NHC) and local ethics committees, not the NMPA (drug authority), although data can later support NMPA IND filings.

Question 36

Are CGT IITs allowed for unapproved products?

Accepted Answer

Yes. While most IITs in China focus on marketed drugs, CGT IITs are an exception due to unmet medical needs and urgent clinical demand. This includes:

CAR-T for relapsed/refractory cancers
Stem cells for degenerative or autoimmune diseases

These are governed by special regulations such as the Stem Cell Clinical Research Guidelines (Trial) and Technical Guidance for Immune Cell Therapy Clinical Trials.

Question 37

What are the benefits of running CGT IITs in China?

Accepted Answer

Faster early-phase clinical data from real-world settings
Lower costs compared to global Phase I/II studies
Opportunity to generate pre-IND safety/efficacy data
Access to large patient populations for rare or advanced diseases
Potential to shorten time to registration by 1.5 years

Question 38

What is the regulatory and ethics review process?

Accepted Answer

Key steps include:

Submit proposal via hospital CTMS
Scientific & ethical review
Approval by hospital’s IIT office
MOH/NHC registration in the Medical Research Registry System
Human genetic resources filing (if applicable)
ClinicalTrials.gov registration

Question 39

Are there restrictions on who can run CGT IITs?

Accepted Answer

Only Tier 1 hospitals with specific credentials may host CGT IITs:

Must hold NHC certification for stem cell/immune cell therapy research.
Require on-site GMP-compliant cell processing facilities or contracted NMPA-licensed CDMOs.
Must demonstrate expertise in managing CGT-related risks (e.g., CRS, neurotoxicity).

Trials must have:

Institutional certification
Clear patient risk controls
Pre-defined stopping rules for severe adverse events

Question 40

Can CGT IIT data support later IND or registration studies?

Accepted Answer

Yes. IIT data—especially long-term safety and early efficacy signals—can be used as:

Supporting evidence for IND submission
Design reference for pivotal trials
Bridging data for conditional approvals

Question 41

Do I need a local sponsor or biotech partner?

Accepted Answer

Not necessarily. Foreign sponsors are no longer required to partner with a local biotech. However:

Using a local CDMO simplifies approvals
Working with an experienced CRO like GCP ClinPlus ensures quality, compliance, and site engagement

Question 42

Why choose GCP ClinPlus as your CRO partner in China?

Accepted Answer

22+ years' experience, with 50+ CGT trials completed
Proven track record across CAR-T, stem cells, oncolytic virus, and gene therapy
Executed 19 IITs in China in diseases including glioblastoma, MM, NSCLC, HCC, β-thalassemia, ALS, and more
Deep relationships with top CGT investigators and elite hospitals
Full-service capabilities from protocol development to site management and data submission

Question 43

What are the future trends in CGT IIT in China?

Accepted Answer

More real-world data integration into regulatory filings
Regulatory upgrades to differentiate gene-editing vs. non-editing therapies
Increasing emphasis on ethics and long-term safety
IITs as a strategic path for market entry

Question 44

How is intellectual property (IP) managed in IITs?

Accepted Answer

Sponsor-owned IP: Default if sponsor funds the trial (defined in the hospital contract).
Joint IP: Possible for investigator-initiated discoveries; rights negotiated upfront.
Publication rights: Hospitals typically require manuscript review

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