Alternative Medicine Regulation

• MFDS achieved WHO maturity level four, the highest level, as the first WHO Member State to reach this level for regulatory systems in both medicines and vaccines
• 750 certified Korean Medicine doctors produced annually through 4-7 year curricula in 12 universities with 22,074 clinicians including 2,474 clinical specialists; national licensing examination with 380 multiple choice items requiring minimum 60% overall and 40% per subject bundle
• Mandatory continuing medical education of eight points annually required since 1965 with license suspension consequences for non-compliance
• National Health Insurance covered Korean Medicine services since 1987, the first time an entire traditional medicine system was insured by an NHI scheme anywhere in the world
• Mandatory medical malpractice liability insurance for all registered medical institutions since 2016; criminal penalties of up to three years imprisonment and 30 million won fines for unregistered medical brokers
• Herbal medicine usage in NHI reduced dramatically; only 0.21% of total pharmaceutical expenditure covers herbal medicines despite 3.6% of total medical expenditure being Korean Medicine, suggesting most herbal medicine practice occurs outside regulated insurance channels
• Despite high demand for Korean Medicine from international patients, there is no official distribution channel for continuing herbal medicine use after foreign patients return home, with current private shipping raising quality and safety concerns

Read the full South Korea report →

• TCAM Unit established by MOHAP in 2002 with nine officially recognized modalities (Ayurveda, Homeopathy, TCM, Acupuncture, Chiropractic, Osteopathy, Naturopathy, Unani, Hijama), all requiring bachelor's degree plus 2 years post-internship experience and standardized written/oral licensing examination
• DHA's 2021 mandate requiring basic health insurance plans to cover approved alternative treatments, with CAM insurance market valued at USD 155 million in 2023 and projected 17.17% CAGR growth through 2030
• Federal Decree-Law No. 38/2024 extends market authorization requirements to traditional medicines, herbal preparations, and food supplements through the Emirates Drug Establishment, with enforcement demonstrated by 2025 legal action against misleading health claims
• Comprehensive facility licensing process with five-stage review, mandatory annual inspections, professional liability insurance requirements, and EMR integration in Abu Dhabi and Dubai
• Multiple complaint pathways through MOHAP, DHA, or DOH with medical liability committees authorized to impose sanctions including license suspension/revocation under Federal Decree-Law No. 4/2016
• Regulatory fragmentation: four separate authorities maintain non-transferable licenses and varying standards, with no publicly searchable disciplinary database limiting consumer transparency for both residents and medical tourists

Read the full United Arab Emirates report →

• T&CM Act 2016 (Act 775) mandates statutory registration for practitioners in seven recognized practice areas (Traditional Malay, Chinese, Indian, Homeopathy, Chiropractic, Osteopathy, Islamic Medical Practice) with 18,802 applications processed as of February 2025
• Mandatory registration commencing March 2021; active enforcement against unregistered practitioners began March 1, 2025 with penalties of RM 30,000 or 2 years imprisonment for first offence
• Dedicated T&CM Division and statutory T&CM Council within Ministry of Health with established Inspectorate and Enforcement Section comprising three operational units
• Product regulation via NPRA with mandatory GMP requirements in force since 1999, updated guidance June 2024; 162 adulterated products identified but active post-market surveillance system in place
• Public online practitioner credential-verification portal (tcmonline.moh.gov.my) allowing independent verification of registration status; T&CM Council formal complaint and disciplinary proceedings system modeled on Malaysian Medical Council
• Deep healthcare system integration with 16 MOH hospitals providing integrated T&CM services and interprofessional collaboration; traditional postnatal care in 104 public clinics across 15 states
• Private facility regulation gap: private T&CM clinics (where most medical tourism treatment occurs) lack statutory licensing or inspection requirements; remedial legislation in pre-drafting public consultation stage as of October–November 2025

Read the full Malaysia report →

• TCM Practitioners Act 2000 with TCMPB as dedicated statutory regulatory body; mandatory registration for all TCM physicians and acupuncturists requiring 5-year bachelor's degree and TCMPB qualifying examination
• Mandatory continuing professional education (50 CPE points per cycle, at least 30 core TCM training) enforced through practising certificate renewal process
• Public searchable TCMPB practitioner registry enabling credential verification; formal disciplinary process with fines up to SGD 50,000, suspension, or registration cancellation
• Chinese Proprietary Medicines subject to mandatory HSA product listing with heavy metal limits (arsenic ≤5 ppm, lead ≤10 ppm), microbial contamination standards, and prohibition on disease-cure claims for 19 serious conditions
• Regulatory vacuum for non-TCM CAM modalities: chiropractors, naturopaths, homeopaths, and energy healers have no mandatory government licensing or registration requirements
• CAM facility licensing under Healthcare Services Act 2020 has been explicitly deferred by MOH; no facility-level standards, inspections, or quality audits required for non-TCM CAM premises
• Formal healthcare system integration: MediSave pilot for acupuncture treatment at public institutions since 2020, TCM Research Grant program (sixth cycle 2025), TCM Integrative Sandboxes launched January 2025

Read the full Singapore report →

• Only four CAM modalities formally regulated (acupuncture, homeopathy, chiropractic, herbalism) while the vast majority operate in complete regulatory vacuum
• NOM-017-SSA3-2012 establishes detailed framework for acupuncture with three practitioner tiers, informed consent, and clinical record requirements, but enforcement is inconsistent across states
• Over 50% of professional chiropractors reportedly practice without following health regulations
• Mexico maintains three-tier herbal product classification (Medicamento Herbolario, Remedio Herbolario, food supplement) with COFEPRIS pre-authorization for advertising claims
• COFEPRIS is PAHO-recognized as a National Regulatory Authority of Regional Reference, but facility inspections for CAM clinics are not systematically reported
• Documented herbal safety gaps despite regulatory frameworks: seven hepatotoxic medicinal plants widely sold with inadequate consumer warnings
• CONAMED medical arbitration system exists but is not CAM-specific, conducted in Spanish only, and lacks authority to revoke CAM practitioner licenses
• No insurance coverage from Mexico's major social security systems (IMSS, ISSSTE) for any CAM treatments
• Public Cédula Profesional registry allows credential verification for regulated practitioners, but no special protections exist for medical tourists
• Constitutional Article 2 and General Health Law formally recognize traditional medicine, enabling institutional integration (National Homeopathic Hospital, acupuncture in public hospitals)

Read the full Mexico report →

• Chiropractic licensure universal in all 50 states with mandatory NBCE exam, accreditation requirements, and continuing education; acupuncture regulated in 47 states plus DC with standardized NCCAOM credentialing enabling interstate reciprocity
• Approximately 11 states have enacted safe harbor laws explicitly permitting unlicensed CAM practitioners to operate legally with only disclosure requirements, creating legal regulatory gaps
• DSHEA 1994 allows an estimated 50,000–80,000 dietary supplement products to market without FDA pre-approval; adverse events severely underreported (FDA estimates 25:1 ratio of actual to reported events)
• No unified federal framework—over 300 individual state and territorial laws govern practitioners with no national disciplinary registry to track sanctioned practitioners across state lines
• Dozens of modalities (herbalism, Ayurveda, traditional naturopathy, energy healing, homeopathy except in 3 states) entirely unregulated at federal level and mostly unregulated at state level
• FTC enforces robust advertising substantiation standards for health claims with no traditional-use exemption; Medicare covers chiropractic and acupuncture for specific conditions

Read the full United States report →

• PNPIC (2006) formally recognizes 29 alternative medicine practices within Brazil's SUS; 7.1 million PICS procedures in 2024 (70% increase over 2022), 9+ million users across 7,700 establishments
• Law 15.345/2026 is the first dedicated national practitioner law for any modality (acupuncture), but 24 other recognized PICS practices remain unregulated for practitioners
• No unified national registry of alternative medicine practitioners; 160,000 acupuncturists operated without unified registry prior to 2026; independent practitioners outside licensed health professions entirely absent from official registries
• ANVISA's RDC 26/2014 establishes sophisticated regulation for herbal and homeopathic products requiring clinical data or documented traditional use; 2025 reform aligns with EMA standards
• No mandatory adverse event reporting system specific to alternative medicine; general pharmacovigilance covers products but not CAM treatment complications
• 557 acupuncture training courses with widely varying hours and curricula; research identifies professional training as key weakness in PNPIC implementation with persistent gaps in uniformity
• Multiple patient complaint channels exist (CFM, COFFITO, ANVISA, ANS, Procon, courts) but practitioners outside licensed health professions face no professional disciplinary mechanism; enforcement absent for unregistered practitioners

Read the full Brazil report →

• Resolution 2927 (1998) formally recognized alternative medicine within Colombia's national health system with technical and administrative standards
• Law 1164 (2007) created formal committee structures and defined recognized alternative medicine categories (TCM, Ayurveda, Naturopathy, Homeopathy)
• 2022 State Council ruling suspended specialist credential requirement, creating regulatory uncertainty that remains unresolved and reducing practitioner qualification standards
• INVIMA maintains comprehensive product regulation for phytotherapeutic medicines (Decree 1156 of 2018) and homeopathic products with mandatory sanitary registration, Good Manufacturing Practices compliance, and post-market surveillance
• Resolution 3100 (2019) requires alternative medicine providers to register in REPS and maintain safety policies with adverse event reporting, but relies on self-evaluation rather than proactive external inspection
• No dedicated alternative medicine regulatory authority exists; oversight is fragmented among Ministry of Health, regional health secretariats, INVIMA, and Superintendencia Nacional de Salud
• No standardized national examination, competency assessment, or mandatory continuing education requirements for alternative medicine practitioners, and no publicly searchable credential database

Read the full Colombia report →

• Heilpraktiker exam requires only passing a 60-question test with no mandatory prior training (Gesundheitsämter licensing pathway)
• 83% of Germany's 165 Heilpraktiker training schools failed professional association standards (2021 study)
• BfArM manages over 6,600 licensed/registered CAM products with Good Manufacturing Practice requirements and three specialist commissions
• 2004–2007 hygiene inspections found 79% of Heilpraktiker practices lacked hygiene concepts; post-licensing oversight is limited to invasive procedures under Infektionsschutzgesetz
• No mandatory continuing education for Heilpraktiker and no public disciplinary register; Patientenrechtegesetz 2013 provides patient rights protections for all providers including Heilpraktiker
• Strong advertising controls under Heilmittelwerbegesetz with administrative fines up to €50,000 and self-regulatory fines up to €400,000

Read the full Germany report →

• Only osteopathy (Osteopaths Act 1993) and chiropractic (Chiropractors Act 1994) have statutory regulation with protected titles; all other major CAM modalities are unregulated.
• Vast majority of CAM practitioners face no legal requirement to register, hold qualifications, or meet minimum standards of practice.
• Care Quality Commission explicitly exempts most CAM clinics from regulated activity registration and inspection.
• No mandatory national adverse event reporting system for CAM practices; MHRA Yellow Card covers products only, not procedures.
• MHRA Traditional Herbal Registration scheme is rigorous and internationally recognized; manufactured herbal products must meet pharmaceutical quality standards and demonstrate 30-year traditional use.
• PSA Accredited Registers programme (CNHC, BAcC) provides rigorous voluntary standards with public complaint processes and published disciplinary decisions.
• ASA strictly enforces CAP Code prohibiting therapeutic claims without clinical trial evidence and prohibiting CAM advertising of disease cures without evidence.

Read the full United Kingdom report →

• Formal legal framework under Act CLIV of 1997 and implementing decrees establishes modality-based regulation with licensing, state examinations, and operating permits for designated CAM practitioners
• Contemporary CAM modalities not enumerated in the 1997 decrees (theta healing, Grabovoj methods, access bars) operate entirely outside regulatory scope, creating a regulatory grey zone
• No public database for verifying natural healer licenses despite formal licensing requirement, while physician credentials are publicly verifiable through OKFŐ
• National health insurance (NEAK) does not reimburse CAM services except NADA ear acupuncture for addiction rehabilitation, indicating minimal healthcare system integration
• Mandatory continuing education (150 CPE credits per 5-year period) and 2020 criminal law penalties (Act CXI of 2019) demonstrate some quality assurance mechanisms but enforcement actions are not publicly documented
• No CAM-specific adverse event reporting system, formal referral pathways, or dedicated complaint mechanisms or language resources for medical tourists

Read the full Hungary report →

• No government licensing or registration exists for any CAM modality in Israel; approximately 60 training programs operate without mandatory state accreditation
• Ministry of Health committees in 1988, 2003, and 2017 recommended CAM licensing but no legislation was enacted due to stakeholder conflicts between Israel Medical Association and CAM professional bodies
• Adverse event reporting through Israel's pharmacovigilance system covers only licensed pharmaceuticals; no systematic surveillance exists for CAM treatment harms
• No systematic inspection regime, accreditation program, or performance monitoring exists for private CAM facilities; MoH disciplinary authority does not extend to unlicensed practitioners
• Voluntary IATCM certification provides quality assurance for Chinese medicine (4-year study plus examination), but applies only to this single modality and lacks legal force
• 74% of Israeli population carries supplementary insurance covering CAM through sick funds; 82 dedicated CAM clinics operate with institutional oversight and regulated pricing
• Seven hospital integrative oncology programs enforce on-site practitioner training, CAM record integration into clinical files, and Helsinki Committee ethics oversight; 2023 professional consensus endorsement of evidence-based integrative oncology guidelines
• Pre-market NFS registration required for dietary supplements with strict therapeutic claims prohibition; homeopathic products require disclaimer labeling; MoH maintains complaint mechanism for misleading advertising

Read the full Israel report →

• Formal legislation exists via the Regulation on Practices of Traditional and Complementary Medicine (October 27, 2014), covering 15 distinct alternative medicine modalities
• Pharmacovigilance regulation has not been clearly established for herbal medicines and alternative treatments, with healthcare professionals able to report only hepatotoxicity and nephrotoxicity to the Ministry of Health
• Practice of alternative medicine restricted to physicians and dentists only, requiring 350 hours education and Ministry examination for homeopathy certification
• University-based GETAT training and application centers established across Turkish universities under Ministry of Health guidance
• Limited public transparency: no readily accessible public database of certified alternative medicine practitioners, disciplinary actions, or enforcement outcomes identified
• Homeopathic remedies are legal to produce, sell, and import but the Turkish Medicines and Medical Devices Agency has not yet approved any homeopathic remedy for market authorization

Read the full Turkey report →

• Jordan has no national CAM policy as of WHO 2019 report, placing it among countries without comprehensive TM/CM policy framework
• Only chiropractic is formally licensed under Public Health Law since 1989; acupuncturists, naturopaths, homeopaths, and herbalists lack licensing requirements
• Herbal medicine pharmacovigilance system received zero adverse event reports 2010–2014; 41.2% of pharmacists would not report adverse reactions despite 63.1% unaware of herb-drug interactions
• Only 76 registered herbal products despite herbal supplements available in 98.5% of pharmacies, indicating large unregistered market; adulteration with synthetic substances documented
• Medical Liability Law No. 25 of 2018 provides patient protections for licensed medical practitioners; applicability to unlicensed CAM practitioners legally uncertain
• No public CAM practitioner register exists; no CAM-specific complaint mechanisms established; HCAC does not accredit alternative medicine facilities
• No healthcare system integration: no mandatory insurance coverage for CAM, no formal referral pathways between conventional and alternative providers

Read the full Jordan report →

• No dedicated national law regulating CAM practitioners; Royal Decree 1277/2003 restricts non-conventional therapies to physician-led health centres, but majority operates in unregistered parasanitary centres outside this regime
• No licensing, certification, or registration requirements for acupuncture, osteopathy, chiropractic, naturopathy; titles are unprotected and anyone may practice
• No mandatory CAM-specific safety protocols, adverse event reporting system, or emergency preparedness requirements for parasanitary centres
• No systematic inspection programme for CAM facilities; enforcement actions rare and typically proceed through criminal channels only
• AEMPS exercises robust regulatory authority over herbal and homeopathic medicinal products; April 2026 action withdrew therapeutic claims from 1,032 homeopathic products
• No mandatory safety standards or patient protection mechanisms in non-registered parasanitary settings; APETP estimates over 1,000 annual deaths linked to pseudotherapies
• CAM excluded from SNS coverage except one regional exception; no formal referral pathways; approximately 23.6% of Spaniards use natural therapies despite absence of regulatory recognition

Read the full Spain report →

• No comprehensive alternative medicine law; 2023 Act on Certain Medical Professions explicitly excluded CAM practitioners despite regulating 15 allied health professions
• No mandatory licensing for non-doctor CAM practitioners; occupational classifications ('acupuncturist' 2010, 'herbalist-phytotherapist' 2014) carry zero educational or examination requirements
• No mandatory safety protocols, informed-consent requirements, or adverse-event reporting for CAM practitioners; no systematic facility inspection regime
• Traditional herbal medicinal products follow EU-harmonized simplified registration via URPL with public register (RPL); dietary supplements regulated by GIS; UOKiK enforces claims restrictions with substantial fines
• Patient Ombudsman, 370+ municipal ombudsmen, and UOKiK provide general consumer-protection recourse; PTTMC and professional associations maintain voluntary credentialing standards

Read the full Poland report →