Clinical Trial Access

• Landmark 2024 'Confianza Supervisada' legislation enables 7-day tacit approval for common-risk trials and 30-day review for high-risk trials, setting legally enforceable timelines among Latin America's fastest
• 240 actively recruiting/imminently recruiting trials on ClinicalTrials.gov (0.39% of global registered trials); 4th in Latin America by density
• 150+ INVIMA/GCP-certified research centers with multiple JCI-accredited hospitals including Fundación Valle del Lili, Santa Fe de Bogotá, and Hospital Pablo Tobón Uribe
• Formal expanded access programs with 10-day INVIMA evaluation timelines and mandated post-trial access continuation at sponsor expense
• World-unique PSEN1 E280A Alzheimer's kindred (~6,000 family members) hosting landmark Genentech/Roche/NIH-funded prevention trial unavailable anywhere else globally
• Explicit gaps: No dedicated clinical-trial medical tourism pathway exists (clinical trials not yet primary marketed medical tourism offering); very limited Phase I trials; language barriers remain at most sites

Read the full Colombia report →

• 8,290+ clinical studies with Israeli participation on ClinicalTrials.gov, 1,420 planned/ongoing studies, 650+ oncology trials—far exceeds 200+ trial threshold
• Five major academic medical centers (Sheba, Hadassah, Rambam, TAMC, Ichilov) with Sheba ranked World's Best Hospital 6 consecutive years; unique TIL therapy for ovarian cancer unavailable elsewhere globally
• 3,284 compassionate use treatments administered 2020-2024 with 60% subsequently approved to national health basket, plus guaranteed 3-year post-trial free drug access under Ministry of Health Guideline 14
• Streamlined regulatory pathway with standard 2-4 month approval and March 2025 fast-track reducing drug approval to 70 days for FDA/EMA-approved medications; FDA Project Orbis membership for concurrent oncology review
• Dedicated medical tourism infrastructure with Ministry-licensed ResultMed, structured international patient departments at all major centers providing multilingual coordination (Hebrew, English, Russian, Arabic)

Read the full Israel report →

• 2,774 active clinical trials as of March 2025, ranking 3rd in Europe; 332 of 392 new 2025 applications to PEI are multinational trials
• Medical Research Act reduced mononational trial authorization to 26–31 days (well below Score 5 threshold of <60 days); Specialized Ethics Committee operational since 1 July 2025
• Multiple world-class research centers: Charité coordinates 600+ trials annually; Heidelberg University Hospital operates dedicated Medical International Office; DKFZ is Europe's largest biomedical research institute; six NCT sites and eight DKTK partner hospitals
• AMHV compassionate use framework with BfArM/PEI oversight; EU's first psilocybin compassionate use program approved July 2025
• Explicit gaps: 'Germany lacks a dedicated clinical trial medical tourism infrastructure' and 'no national program mandating multilingual trial information'; trial consent forms and communications frequently available in German only

Read the full Germany report →

• 747 MFDS-approved clinical trials in 2024 (half multinational), with 636 IND approvals in 2025 and 70% from international sponsors; combined MFDS + IRB approval in 4–8 weeks (far exceeding 60–120 day benchmark)
• Five major academic medical centers—SNUH, Asan Medical Center, Samsung Medical Center, Severance Hospital, and Seoul National University Bundang Hospital—collectively completed 2,258 studies over five years; Asan conducts 300+ trials annually with 20% Phase I; SNUH's 24/7 Phase I oncology ward managed 525 trials over 2013–2018
• 26+ dedicated Phase I units with 714+ research beds; 200+ MFDS-certified clinical trial sites and 15,000+ research professionals; 99.6% national health insurance enrollment enabling rich longitudinal EMRs for patient identification
• Compassionate use program available under Pharmaceutical Affairs Act Articles 28–29 and Article 34(4), with individual patient approvals in 7 days and multiple-patient approvals in 30 days for life-threatening conditions; KODC-Anova partnership expanding framework reach
• Critical gap: no dedicated national program linking medical tourists with clinical trial enrollment; CRIS registry operates entirely in Korean; international enrollment requires physician-to-physician referral rather than public self-service pathway; no publicly documented international patient outcomes in clinical trials

Read the full South Korea report →

• 197,090 total registered trials (1999-June 2025) with 500,000+ studies in ClinicalTrials.gov, world's largest clinical trial registry
• 99% authorization rate for ~9,000 expanded access applications over five years, demonstrating exceptional compassionate use infrastructure
• Multiple world-renowned clinical research centers with international patient programs: MD Anderson (International Center with language support), Mayo Clinic (1.3M patients annually from 130 countries), Johns Hopkins, Cleveland Clinic, NIH Clinical Center (500,000+ international participants since 1953)
• Priority given to US citizens and residents limits international recruitment, and international patients must self-fund travel and obtain B-2 visas, creating significant access barriers

Read the full United States report →

• CenterWatch lists 339 active trials in Abu Dhabi and 295 in Dubai; ADHRC manages 200+ active studies across 22 therapeutic areas
• Abu Dhabi Department of Health achieves 28-day clinical trial approvals; federal MOHAP process takes 6-12 months, creating inconsistent regulatory timelines
• Three major AAHRPP-accredited research centers: Cleveland Clinic Abu Dhabi (March 2025), Sheikh Shakhbout Medical City with Mayo Clinic partnership, and PureHealth's SEHA/ADHRC (April 2026)
• Federal Decree-Law 38/2024 establishes compassionate use and Emergency Use Authorization pathways, but implementing regulations remain unpublished as of early 2026
• Report states no dedicated international patient clinical trial program exists; most UAE-based trials recruit patients residing in UAE rather than through deliberate international outreach

Read the full United Arab Emirates report →

• Brazil maintains 1,500+ active clinical trials with 4,735 recruiting in REBEC (national registry) as of October 2025, exceeding the 100+ threshold for Score 4
• Law 14.874/2024 (effective August 2024) reduced ethics committee review from 180 days to 30 business days and ANVISA regulatory review from 12+ months to 90 business days, with parallel simultaneous review now permitted
• No formal framework or dedicated pathway facilitates foreign patient enrollment; the report states international patients must navigate trials independently, establish direct contact with Portuguese-only administrative staff, and face officially-mandated Portuguese-language documentation requirements
• Expanded access programs exist under RDC 38/2013, but neither existing nor proposed revisions explicitly address eligibility for foreign or non-resident patients; access in practice is processed through Brazilian physicians at Brazilian facilities
• Hospital Israelita Albert Einstein operates an International Patient Center with multilingual coordinators, but public academic research centers (HCFMUSP, INCA) are predominantly Portuguese-only; geographic concentration (77% of centers in South/Southeast) limits access for international patients

Read the full Brazil report →

• 578 pharmaceutical interventional commercial trials initiated in 2024 with 41-day average combined regulatory approval, representing the most significant UK clinical trial regulatory overhaul in over two decades
• The Christie Hospital operates world's largest Phase I clinical trials unit (~200 simultaneous trials, ~2,400 patients/year); Royal Marsden/ICR enrolls ~300 patients annually in Phase I studies
• EAMS compassionate use program has benefited 1,200+ patients since 2014 but explicitly excludes non-UK residents; no structured expanded access pathway exists for international patients
• Industry trial participants declined 25% from 2022/23 to 2024/25 (lowest in eight years), with only 27% of commercial studies opening to recruitment within 60 days, despite strong infrastructure
• Report explicitly states 'No dedicated medical tourism clinical trial infrastructure exists' and access for international patients is 'sometimes possible, but can be very difficult' and relies on opaque, inconsistent physician referrals

Read the full United Kingdom report →

• 9,000+ trials registered on ClinicalTrials.gov and 15,000+ on jRCT, with NCCH conducting 507 registration-directed trials and maintaining seven authorized medical coordinating agents for international patients
• Only 31 expanded access clinical trials conducted over five years (1.5% activation rate); no single-patient emergency access pathway, restricting access to experimental drugs until late in development phases
• Language barriers identified as 'the most significant practical obstacle,' with over 50% of non-native Japanese speakers requiring professional medical interpretation; clinical protocols, consent documents, and safety monitoring conducted entirely in Japanese

Read the full Japan report →

• ~5,000 clinical studies registered on ClinicalTrials.gov with 2,354 in Phase III as of April 2024; Mexico is Latin America's second-largest clinical trials market at USD 379.51 million (2025)
• INCan holds ESMO designation and treats 5,000+ new cancer patients annually; CHRISTUS Muguerza maintains CAP-certified laboratory and unbroken JCI accreditation since 2007
• Historical approval timelines of 6–10 months total (3–6 months institutional review + 90-day COFEPRIS evaluation), among the slowest in Latin America, though COFEPRIS announced 45-day target
• No formal national expanded access or compassionate use program; access to investigational treatments is case-by-case through COFEPRIS or multinational manufacturer programs
• All clinical trial documentation must be in Spanish; no multilingual trial coordination infrastructure at national level despite 1.4–3 million annual medical tourists

Read the full Mexico report →

• 267 sponsored clinical trials in 2024, ranked #2 in Southeast Asia and #28 globally; parallel NPRA/MREC submission enables ~120-day regulatory startup within Score 4 range
• Three Phase I accredited research units (SGH fully accredited, Hospital Ampang accredited 2024, UMMC pending 2026); Institut Kanser Negara and 50+ total trial sites across 20+ therapeutic areas
• No dedicated international patient enrollment pathway or coordinator network; clinical trial and medical tourism sectors remain siloed despite strong MHTC medical visa and hospital support infrastructure
• Compassionate use available under CDCR 1984 Reg. 15(6) but primarily designed as post-trial extension; international patients without prior Malaysian trial enrollment require Malaysian physician involvement; no named patient programs

Read the full Malaysia report →

• 1,395 open studies registered with 73% international sponsorship, placing Poland among Europe's top clinical research hubs
• Regulatory approval timeline of 60 days meets efficiency benchmarks, and the 2023 Clinical Trials Act modernized the framework with EU alignment
• Maria Skłodowska-Curie NRI manages 650+ trials with EORTC membership, JCI Clinical Trials Center provides modern facilities, and PCTN operates 23 Clinical Trial Support Centres
• Complete absence of formal compassionate use or expanded access programs, explicitly identified as the most consequential deficiency for international patients seeking experimental treatments outside formal trials
• Mandatory Polish-language informed consent documentation and no national translation services for international patients, combined with no dedicated medical tourism integration or facilitation agencies

Read the full Poland report →

• 527 clinical trials conducted in 2024 with over 11,000 conducted since 1999 (highest in Southeast Asia)
• Thai FDA Ethics Committee approvals take several months, with no streamlined process for international patients
• No documented compassionate use or expanded access programs for international patients in Thailand
• Thailand has more JCI-accredited hospitals than any other Asian country, with Siriraj and Bumrungrad offering clinical trial access
• Thai Clinical Trials Registry established 2009, WHO primary registry since August 2013 with all registrations in English

Read the full Thailand report →

• India has 94,730 trials registered since 2000, third-largest destination globally with 18,000 new trials in 2024 alone (CDSCO regulatory data)
• Regulatory approval timeline of 90 working days accommodates international participation within reasonable efficiency range; reforms increased approvals 67% between 2019-2023 (CDSCO data)
• Multiple world-class research centers exist including Tata Memorial Center (10+ cancer institutes registering 120,000 cancer patients annually), AIIMS, and ICMR-Network for Phase 1 Clinical Trials (established May 2024)
• Compassionate use framework is nascent stage lacking formal policies and laws; June 2020 proposed amendment for expanded access imports remains in draft and has not been incorporated (Ministry of Health proposal, 5-year gap)
• No documented explicit pathways for international patients: 'international patient-specific policies and infrastructure for facilitating medical tourism for clinical trial participation remain underdeveloped'; no dedicated facilitators, visa programs, or international patient coordinators identified
• Medical tourism infrastructure (650,000 foreign tourists in 2024, $18.2 billion market) is disconnected from clinical trial access with no documented integration or support services for international trial participants

Read the full India report →

• 2,699 active clinical trials as of 2023 with 750 industry-sponsored interventional studies
• No international IRB accreditation exists among 78 Institutional Review Boards across 34 provinces
• 4-6 week approval timeline for clinical trials through EU-aligned TİTCK regulatory processes
• 42 compassionate use programs since 2006 treating 1,247 patients, focused on oncology conditions
• 84% of trials locally sponsored, indicating limited participation in multinational international trials
• Absence of dedicated international patient coordinators or specialized medical tourism packages for clinical trial participation

Read the full Turkey report →

• 484 registered clinical trials per 2025 systematic review (362 interventional), exceeding Score 3 volume threshold but recruitment explicitly documented as 'very limited' domestically
• KHCC holds AAHRPP accreditation (8th globally) and serves as EORTC Middle East Co-ordinating Office with 6 active EORTC trial partnerships, but international recruitment not systematically marketed
• No formal JFDA-level expanded access or compassionate use program for international patients; only 2 expanded access records in Jordan's ClinicalTrials.gov history
• Regulatory approval timeline 30–90 days is competitive within MENA, but regulations lack specific international patient enrollment provisions
• 13 CROs in Amman (IPRC 180 beds, JCPR 120 beds) hold FDA/EMA credentials but primary orientation is Phase I bioequivalence studies for healthy volunteers, not disease-treatment trials

Read the full Jordan report →