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International patients considering medical care in China often ask: “China has so many new drugs and clinical trials — can I participate?” This is a question that deserves an honest answer — false hope is harmful to patients. This article provides an honest assessment: international patient participation in formal Chinese new drug clinical trials is largely impractical in most cases; however, accessing imported drugs unavailable in your home country through Hainan Boao Lecheng and similar special medical zones is a genuinely feasible pathway. Understanding this distinction helps you make realistic medical decisions.

China’s Clinical Trial Scale and Development

China’s clinical trial sector has grown rapidly over the past decade:

Joined ICH (International Council for Harmonisation) in 2017: NMPA began accepting overseas clinical trial data conforming to ICH guidelines; MRCT (multi-regional clinical trials) became a mainstream pathway for new drug approval in China [1].

2024 data [2]:

  • CDE registered clinical trials: 4,900 projects (+13.9% YoY)
  • New drug-related: 2,539 projects (51.8%)
  • BE (bioequivalence) studies: 2,361 projects

International comparison [3]:

  • WHO ICTRP + ITIF analysis: 2024 China registered approximately 7,100 clinical trials, surpassing the United States (approximately 6,000) for the first time
  • 2023 China registered interventional trials exceeded 11,000, approximately 50% more than the US

Core implication: China is one of the largest clinical trial markets globally — but a large number of trials does not mean international patient participation is easy.

Real Barriers to International Patient Participation in Chinese Clinical Trials

Barrier 1 · Human Genetic Resources Management Regulations (effective July 2019)

This is the largest institutional barrier [4]:

  • Explicitly prohibits foreign entities from collecting, preserving, or providing human genetic resources to overseas locations in China
  • Foreign parties must cooperate with Chinese parties for research; sample and derived data export requires Ministry of Science and Technology approval
  • Violations carry fines of RMB 1 million–10 million, or 5–10 times the illegal proceeds

Although the regulations primarily target “Chinese human genetic resources” export, they also create significant compliance burdens on trial procedures involving foreign participants — leading many research centers, due to compliance costs, to avoid enrolling foreign patients in practice.

Barrier 2 · Trials Designed Around Local Follow-Up

The vast majority of NMPA-registered clinical trials in China are designed with the default assumption that participants will reside in China for long-term follow-up:

  • High follow-up frequency (oncology trials typically every 4–8 weeks)
  • Imaging, lab work, and biological sample collection at the trial site
  • Adverse event monitoring and emergency management require on-site presence
  • International patients cannot bear the cost of long-term China residence — returning home means loss to follow-up, which invalidates trial data

Barrier 3 · Insurance and Payment Barriers

  • The trial drug itself is typically provided free
  • But pre-trial screening, concomitant medications, adverse event management, and long-term follow-up tests require self-payment
  • Chinese health insurance covers only Chinese residents — all costs for international patients are out-of-pocket
  • Actual total expenditure may equal commercial treatment costs

Barrier 4 · Language and Cultural Barriers

  • Informed consent forms, trial protocols, medical orders, and follow-up questionnaires are all in Chinese
  • Most trial centers lack dedicated international patient coordinators
  • Communication misunderstandings can affect data integrity, leading researchers to avoid foreign enrollment

Combined conclusion: For the vast majority of international patients, “participating in a Chinese new drug RCT” is impractical in actual implementation — this is the honest reality.

Hainan Boao Lecheng: The Genuinely Feasible “Chinese New Drug Access” Pathway

Boao Lecheng International Medical Tourism Pilot Zone is China’s only medical special economic zone with a complete “special licensed medical care + international medical exchange” policy framework. Key fact:

Lecheng provides “legal use of drugs approved overseas but not approved in China,” not enrollment in new drug RCTs in China — this distinction must be clear.

“Four Special Authorizations” policy [5]:

  • Special licensed medical care: permits use of imported drugs and medical devices approved abroad but not in China within the Lecheng zone
  • Special licensed research: permits early-stage clinical research at Lecheng
  • Special licensed operation: medical institution operating authorization
  • Special licensed international medical exchange: foreign physician practice, cross-border medical collaboration

As of the latest public reporting [5]:

  • 485 imported drugs and devices already approved overseas but unapproved in China have been introduced through “special license”
  • 130,000+ patients have benefited
  • Real-world data (RWD) pilot: 10 drugs selected; 4 received NMPA marketing approval based on Lecheng RWD (pralsetinib, trilaciclib, inclisiran, fluocinolone intravitreal implant)
  • Urgent clinical drug/device approval compressed from standard process to 3–7 days

Real value of Lecheng for international patients:

For international patients, Lecheng’s core value scenario is:

  • You already have access to drug X in your home country, but supply is short or pricing is prohibitive
  • Drug X is not approved elsewhere in China, but has been imported into Lecheng via special license
  • You travel to Lecheng to legally use drug X at lower cost than at home

Typical cases: rare disease drugs, targeted oncology drugs, novel biologics, medical devices (especially products approved in Europe/US but not in multiple Asian countries).

2024–2025 Lecheng data [6]:

  • 2024 medical tourists 413,700 visits (+36.8% YoY)
  • 2025 reached 865,300 visits (+109%)
  • Foreign physician short-term practice approval reduced from 52 working days to 15 working days; practice period extended to 3 years
  • 86 visa-exempt countries apply (see Article 7 on visas)
  • Zero-tariff policy for imported drugs and devices (since December 2024)

Best-suited international patient profile for Lecheng:

  • Your home country has not approved or cannot supply drug X
  • Drug X has been imported through Lecheng’s special license
  • You can bear Lecheng’s medical care costs (comparable to or slightly higher than other major Chinese cities)
  • Your condition requires sustained drug supply rather than short-term treatment

Other Realistic Pathways International Patients Can Explore

Pathway A · Overseas-Approved + China Domestic Approved Drug Pathway

Many drugs that are NMPA-approved in China (especially Chinese domestic PD-1, ADC, TKI, etc. — see Article 27) are fully compliant for use by international patients as standard prescriptions:

  • International patient consults at Chinese IMD
  • Chinese physician prescribes
  • Medication obtained at Chinese pharmacy or hospital pharmacy
  • This is not “clinical trial participation” — it’s standard medical use of NMPA-approved drugs

This pathway is the most practical way for international patients to access Chinese innovative drugs — pricing is far below US (see Article 27) and access is much easier than “participating in a trial.”

Pathway B · MRCTs by Chinese Biotechs Conducted Overseas

Some Chinese innovative pharmaceutical companies (BeiGene, Innovent, Junshi, Hutchmed, etc.) conduct international multi-center trials abroad:

  • Trial sites may be in the US, Europe, Australia, Singapore, etc.
  • These trials are open to local patients — but patients must reside near the trial site
  • International patients can search whether such trials exist in their home country: search ClinicalTrials.gov for “Chinese sponsor names”

Pathway C · Compassionate Use / Expanded Access

China’s 2019 Drug Administration Law Article 23 recognizes compassionate use [7]:

  • Applicants are typically pharmaceutical companies, not individual patients
  • Use is limited to “the medical institution conducting the clinical trial”
  • Requires IRB approval
  • CDE decides within 30 days

Real implication for individual international patients: essentially does not constitute a realistic pathway — this is designed for pharmaceutical companies to “expand use” of drugs already in clinical research, not to open new pathways for individual patients.

Synthesized Realistic Recommendations

For international patients, ranked by feasibility:

Pathway Feasibility Best-Fit Scenario
Lecheng special licensed use of overseas-approved drugs High Drugs approved abroad but unapproved/in short supply/unaffordable at home
Chinese NMPA-approved drug standard prescription High Chinese domestic innovative drug pricing advantage (PD-1, ADC, TKI, etc.)
Joining MRCTs by Chinese Biotechs in your home country Medium Condition-matching specific trials; requires search of ClinicalTrials.gov
International patient joining NMPA-registered trials inside China Low Only select academic institutions’ investigator-initiated trials (IIT); requires case-by-case evaluation
Individual compassionate use application Very low Essentially not feasible

Four-Step Practical Pathway for International Patients

Step 1 · Clarify Your Target Drug or Treatment

Organize the following information:

  • The drug you need (generic name)
  • The drug’s availability status in your home country (approved but unavailable / unapproved / unaffordable)
  • The drug’s status in China (NMPA-approved / Lecheng special license imported / not introduced at all)

Step 2 · Identify the Most Suitable Pathway

  • NMPA-approved in China → use through standard Chinese IMD prescription (see Article 27)
  • Imported through Lecheng special license → use through Lecheng
  • Neither path available → consider other countries (Singapore, Japan, Switzerland, Germany)

Step 3 · Remote Consultation for Confirmation

Through MedCareInChina remote second opinion (see Article 9) — specialists assess whether the drug is appropriate for your specific case and the most suitable access pathway

Step 4 · Actual Access

  • Standard NMPA drug: direct travel to the corresponding IMD
  • Lecheng special licensed care: entry through Haikou Meilan Airport (some visa-exempt) + admission to Lecheng zone partner hospital

Common Questions

Can I participate in a Chinese CAR-T clinical trial? In practice, very few international patients can join NMPA-registered clinical trials. However, NMPA has approved 6 CAR-T products (see Article 21), available to international patients as standard clinical treatment.

Can Lecheng really give me access to drugs I can’t get at home? Provided the drug has been imported through Lecheng’s special license. Currently 485 imported drugs/devices approved abroad have been brought in through Lecheng [5] — you need to first verify whether your specific drug is on the list. MedCareInChina can check on your behalf.

What’s the difference between using a drug at Lecheng vs at a regular hospital? Lecheng’s “special licensed medical care” allows you to legally use drugs in China that are not yet approved elsewhere in China; regular hospitals can only use NMPA-approved drugs. Both are legal medical activities; the difference is the range of accessible drugs.

Can I take medications used at Lecheng back to my home country? Depends on home country customs regulations. Principles:

  • Same drugs already approved in your home country: typically allowed
  • Drugs not approved in your home country (even if legally used at Lecheng): bringing back home may violate import regulations — confirm with home country regulations before traveling
  • International shipping not recommended — typically illegal

How do I find MRCTs by Chinese Biotechs in my country (e.g., the US)? Search ClinicalTrials.gov for specific pharmaceutical company names (BeiGene, Innovent, Junshi Biosciences, etc.) + your disease — you’ll see these companies’ trials in your home country.

If I’m successful in joining a Chinese clinical trial, can I get the drug? Even if you can join, post-trial drug continuation is also a challenge — most trials only provide free drugs during the trial period; long-term use requires purchasing the drug after formal approval. For international patients, using NMPA-approved drugs is more realistic than pursuing trial enrollment.

Bottom Line

Honest answer to international patients about “Chinese clinical trials and new drugs”:

Reality Explanation
✅ China has more clinical trials than the US But international patient participation is difficult institutionally and practically
✅ Hainan Boao Lecheng is a genuinely feasible pathway Used for accessing drugs approved abroad but unavailable at home, not joining new drug RCTs
✅ Chinese NMPA-approved drugs accessible to international patients This is the most practical “Chinese innovative drug” access pathway (see Article 27)
❌ Joining clinical trials inside China Mostly impractical
❌ Individual compassionate use application Essentially not feasible

Most practical recommendations:

  • Want to use Chinese domestic innovative drugs (PD-1, ADC, TKI, etc.) → standard IMD prescription
  • Want to use drugs approved abroad but unavailable at home → Hainan Boao Lecheng
  • Want to join new drug trials → first search ClinicalTrials.gov in your home country; don’t pin hopes on “Chinese trial enrollment”

If you want to assess which pathway suits your specific situation, MedCareInChina provides realistic recommendations based on your drug needs and geographic location — and will honestly tell you when “China is not the optimal solution.”

→ Send your case to hello@medcareinchina.com

See Service & Refund Policy and Medical Disclaimer for service boundaries.

Sources

  1. China joined ICH in 2017 — NMPA accepts overseas clinical trial data conforming to ICH guidelines. Source: ISPE https://ispe.org/pharmaceutical-engineering/march-april-2024/evolving-chinas-regulatory-system-alignment-ich
  2. 2024 CDE clinical trial data — 4,900 trials registered, 2,539 new drug-related. Source: Covington Blogs https://www.covingtonblogs.com/2025/07/21/chinas-drug-regulator-releases-report-on-clinical-trial-progress-in-china/
  3. China vs US clinical trial count — 2024 China ~7,100 trials, US ~6,000. Source: ITIF https://itif.org/publications/2025/06/09/china-surpassed-us-number-drug-clinical-trials-1-100-more/
  4. Human Genetic Resources Management Regulations (2019) — Prohibits foreign entities from collecting, preserving, or providing human genetic resources overseas in China. Sources: WilmerHale https://www.wilmerhale.com/en/insights/client-alerts/20200730-china-to-strengthen-regulation-of-human-genetic-resources ; China Briefing https://www.china-briefing.com/news/chinas-human-genetic-resources-regulation-implementation-rules-key-points-for-foreign-stakeholders/
  5. Hainan Boao Lecheng “Four Special Authorizations” and data — As of the latest public reporting, 485 imported drugs/devices approved abroad but not in China have been introduced; 130,000+ patients benefited. Urgent clinical drug/device approval in 3–7 days. Sources: China.gov.cn https://english.www.gov.cn/news/202507/05/content_WS6868ce92c6d0868f4e8f3dc5.html ; Hainan Government https://en.hainan.gov.cn/englishsite/iind/202506/b3a75ac6a20e4c71a0e0aac1951cb361.shtml ; PMC https://pmc.ncbi.nlm.nih.gov/articles/PMC11718740/
  6. Lecheng 2024–2025 data — 2024 medical tourists 413,700 (+36.8%); 2025 reached 865,300 (+109%); foreign physician practice approval reduced to 15 working days; 86 visa-exempt countries apply; zero-tariff policy on imported drugs and devices.
  7. China Drug Administration Law Article 23 (Compassionate Use) — Implemented 2019; applicants are typically pharmaceutical companies. Sources: Pharma Boardroom https://pharmaboardroom.com/articles/evolving-compassionate-use-and-named-patient-programs-across-asia-pacific/ ; Frontiers in Medicine https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1642882/full