WHO Global Traditional Medicine Strategy 2025–2034

Strategic objective 2. Support the provision of safe and effective TCIM through appropriate regulatory mechanisms 

 Rationale.  Appropriate regulatory mechanisms are crucial for TCIM to safeguard the public from unsafe or substandard TCIM products and services. A risk-based regulatory approach is well suited to TCIM, tailoring regulatory requirements to the specific type of TCIM products or services based on safety and efficacy. This involves establishing appropriate participatory mechanisms, quality control measures, standards and labelling requirements, as well as ensuring that the intended use is justified and rational. The highest standard of science and stringent regulatory provisions, as appropriate to national requirements, should apply for TCIM products and services used for medical purposes to ensure their safety, quality and effectiveness in clinical settings. Regulatory mechanisms for TCIM practitioners must prioritize patient safety. TCIM practitioners cannot be considered as a single group due to the diverse nature of TCIM modalities, therapeutic approaches, training, practice and practitioners’ division of labour. The identification and establishment of common norms and standards for qualifications, competencies and ethical conduct contribute to ensuring that practitioners have the necessary knowledge and skills to deliver safe and effective care (...)

Direction 2.2. Provide appropriate regulatory mechanisms for TCIM practices and practitioners 

Rationale.  Regulatory frameworks should be adapted to the different forms of TCIM practices and practitioners. They should also be aligned with TCIM policies to support the preservation and strengthening of TCIM knowledge and practices that are safe and effective, while preventing misappropriation.

Regulatory frameworks should consider – based on health system objectives, risk profiles and regulatory capacity in the local context – appropriate standards for educational programmes, certification and licensing requirements to ensure that TCIM practitioners have the knowledge and skills to deliver safe and effective care. 

Balanced frameworks contribute to interprofessional collaboration and the coordination of service delivery across the spectrum of health and social care systems, enabling a holistic and integrated approach to people-centred care. 

 Actions for Member States 

 • Establish or strengthen appropriate regulatory mechanisms to promote safe and effective TCIM practices, while recognizing their diversity. 

 Develop appropriate quality standards of medicinal preparations made by TCIM practitioners. 

 • Develop standards, guidelines and codes of conduct to promote responsible and accountable TCIM practices. 

 • Adopt or refer to WHO technical documents in developing minimum training requirements, including ethics for TCIM practitioners. 

 • Set training requirements for TCIM practitioners, including ongoing professional development. • Collect, analyse and use data on the TCIM health workforce for improved planning and accountability. Actions for partners and stakeholders 

 • Promote a dialogue between TCIM professional associations with regulatory authorities for standards pertaining to education, practices and practitioners. 

 • Encourage regulators, training institutions and professional organizations to support national and local health workforce data collection, analysis and use for improved planning and accountability. • Support research on the impact of regulatory systems in reference to patient safety and population health outcomes. Actions for the WHO Secretariat 

 • Develop a WHO international classification and qualification framework for TCIM practitioners and provide technical guidance to countries. 

 • Develop and/or update WHO technical documents in TCIM.

 • Improve health workforce data on TCIM practitioners through regular reporting in the WHO National Health Workforce Accounts Data Portal and complementary surveys and reports.

Facilitate information sharing between Member States and partners regarding approaches to and experiences with the regulation of TCIM practices and practitioners in different settings.

Draft global traditional medicine strategy 2025–2034