编者按：2025年12月18日，《中国日报》（China Daily）刊发题为Robust regulation key to promoting TCM globally 的英文报道，采访了世界针灸学会联合会副主席拉蒙·马利亚·卡尔杜克（Ramon Maria Calduch）。文章围绕中医药全球发展中的监管体系、科学证据评价与国际标准建设等议题，系统阐述了其观点。现将该文编译转发，供读者参考。

Robust regulation key to promoting TCM globally

By WANG XIAOYU | CHINA DAILY | Updated: 2025-12-18 09:00

Ramon Maria Calduch

Traditional Chinese medicine has significantly expanded its global presence over the past five years, alongside growing international recognition of the need to develop scientific evaluation models suited to TCM and to establish robust regulatory systems to support its development, according to a healthcare expert.

Looking ahead to the 15th Five-Year Plan period (2026-30), Ramon Maria Calduch, president of the European Foundation of Traditional, Complementary and Integrative Medicine, called for more focused international cooperation on regulation, evidence methodology and capacity building to promote the high-quality integration of TCM into diverse healthcare systems worldwide.

In an interview with China Daily, Calduch said TCM's inclusion in national strategies such as the Healthy China initiative, the growing number of overseas TCM centers, and sustained investment in service quality, professional training, and clinical and basic research have collectively strengthened its international footprint.

He noted that China has also enhanced community-level TCM services, promoting care that combines TCM with Western medicine, while establishing advanced research platforms that integrate modern scientific methods with TCM knowledge.

"These domestic advances carry significant global relevance by demonstrating the potential of integrative healthcare models in which TCM and Western medicine complement each other," Calduch said. "At the same time, foreign countries are gaining access to better information to evaluate the prospects of introducing TCM into their own systems.

"The modernization of TCM in China is not only an internal process," he added. "It is also a reference laboratory from which other countries can draw to advance their own regulation and integration of TCM."

According to Calduch, one of the most important strategic developments in TCM's global advancement is the growing awareness that it requires an internationally accepted model for evaluating scientific evidence. Equally important is the recognition that its international expansion must be underpinned by solid regulatory frameworks in each adopting country.

"There is increasing acknowledgment of the need for evidence-evaluation models that respect TCM's holistic diagnostics and personalized treatments, rather than forcing it into paradigms designed for isolated chemical drugs," he said.

He pointed to growing cooperation between Chinese and international research teams to adapt research designs to TCM's characteristics, including pragmatic trials, real-world effectiveness studies and mixed-method approaches.

"This is the right direction — not abandoning rigor, but adjusting method to subject," Calduch said.

Parallel to this progress, he said, is a shared understanding that sound national regulatory systems covering training, licensing, quality control and patient safety are prerequisites for responsible integration.

Calduch cited tangible advances in global TCM standardization, including technical benchmarks and clinical guidelines for acupuncture and moxibustion developed by the World Federation of Acupuncture-Moxibustion Societies, as well as standards issued by the World Federation of Chinese Medicine Societies and the World Health Organization.

As countries face ongoing pandemic risks and a rising burden of chronic disease, Calduch said TCM offers distinct advantages.

"TCM places strong emphasis on prevention and early management, which aligns closely with the concept of resilient health systems centered on health promotion," he said.

"Integrated interventions such as herbal medicine, acupuncture and Tui Na can complement conventional medical protocols in the prevention and rehabilitation of infectious diseases, as well as in the management of complex chronic conditions," he added.

According to the Recommendations of the Communist Party of China Central Committee for Formulating the 15th Five-Year Plan for National Economic and Social Development that was released in late October, China has proposed promoting the preservation and innovative development of TCM, as well as the integrated application of TCM and Western medicine.

Looking ahead to the next five years, Calduch said China can further strengthen these advantages by deepening TCM integration in primary care and chronic disease management, developing research platforms for public health emergencies, and leveraging digital health technologies.

At the same time, he identified improving the quality of international applications as the main challenge in expanding TCM's global role.

"This means China should not limit itself to promoting TCM services abroad, but should also engage in sharing and jointly building standards for scientific evidence and regulation," he said. "Without clear regulatory frameworks, no national health system can responsibly integrate acupuncture and TCM into its benefits package."

Calduch said the top priority is helping countries regulate TCM before integration, including defining professional accreditation, facility standards, safety protocols and oversight mechanisms.

"China should promote, together with the WHO and academic institutions across continents, an internationally accepted model for evaluating evidence in TCM," he said.

"If consensus can be reached on how to conduct research and interpret evidence in TCM, it will be much easier for national regulators to decide which interventions to incorporate into their public health systems," he added.

He also said major overseas TCM cooperation projects should engage in sustained dialogue with local health authorities to align TCM with national legal and coverage structures.

"If China combines its clinical and scientific strengths with a clear strategy to support regulatory development in other countries, TCM can be incorporated into national health systems gradually, safely and sustainably," Calduch said. "This would benefit population health and strengthen global health cooperation."

Over the long term, he said, TCM's global advancement will be more sustainable and gain wider acceptance by being firmly grounded in shared scientific research, internationally recognized standards and the principle of mutual benefit.

"China has already taken important steps during the 14th Five-Year Plan period (2021-25)," Calduch said. "The challenge now is to deepen this path in a more open, cooperative way, oriented toward measurable outcomes for population health."

译文：

健全监管是推动中医药走向世界的关键

——拉蒙·马利亚·卡尔杜克谈中医药全球发展

中国日报记者 王小予

　　欧洲传统补充整合医学基金会 (西班牙) 主席、世界针灸学会联合会副主席拉蒙·马利亚·卡尔杜克（Ramon Maria Calduch）在接受采访时表示，过去五年来，随着国际社会日益认识到有必要建立适合中医药特点的科学评价模型，并构建完善的监管体系以支持其发展，中医药在全球范围内的影响力不断提升。

　　展望“十五五”时期（2026—2030年），拉蒙呼吁在中医药监管、证据方法学和能力建设等领域开展更加聚焦的国际合作，推动中医药高质量融入全球多元医疗卫生体系。

　　在接受《中国日报》采访时，拉蒙指出，中医药被纳入“健康中国”等国家发展战略、海外中医药中心数量持续增长，以及在服务质量、专业人才培养和临床及基础研究方面的持续投入，共同增强了中医药的国际影响力。他表示，中国还不断强化基层中医药服务体系，推动中西医结合诊疗模式，同时建立融合现代科学方法与中医药知识的先进科研平台。

　　“这些国内进展对全球具有重要示范意义，展示了中医药与西医相互补充的整合型医疗模式的巨大潜力。”拉蒙说，“与此同时，其他国家也正在获得更加充分的信息，以评估将中医药引入本国医疗体系的可行性。”

　　他进一步指出：“中国中医药的现代化不仅是一个内部发展过程，同时也可作为一个‘参考实验室’，为其他国家推进中医药监管和融合发展提供借鉴。”

　　拉蒙认为，中医药实现全球发展的最重要战略进展之一，是国际社会逐渐形成共识，即中医药亟须建立国际认可的科学证据评价模式。同样重要的是，其国际推广必须以各国健全、可靠的监管框架为支撑。“越来越多的人认识到，证据评价模型应尊重中医药整体辨证和个体化治疗的特点，而不是强行套用为单一化学药物设计的研究范式。”他说。

　　他还指出，中外科研团队之间的合作不断深化，研究设计正逐步向更符合中医药特性的方向调整，包括务实性临床试验、真实世界研究以及混合研究方法等。“这是一条正确的发展方向——不是放弃科学严谨性，而是让研究方法与研究对象相匹配。”拉蒙表示。

　　与上述进展并行的，是国际社会逐渐形成共识：涵盖人才培养、执业许可、质量控制和患者安全的国家监管体系，是中医药负责任融入医疗体系的前提条件。拉蒙列举了中医药国际标准化方面取得的具体成果，包括世界针灸学会联合会制定的针灸和艾灸技术基准与临床指南，以及世界中医药学会联合会和世界卫生组织发布的相关标准。

　　在各国持续面临疫情风险和慢性病负担不断加重的背景下，拉蒙认为，中医药具有独特优势。他说：“中医药高度重视预防和早期干预，这与以健康促进为核心、强调韧性的卫生体系理念高度契合。”

　　他进一步指出：“包括中药、针灸和推拿在内的综合干预手段，可在传染病防治与康复以及复杂慢性疾病管理中，有效补充现代医学诊疗方案。”根据2025年10月下旬发布的《中共中央关于制定国民经济和社会发展第十五个五年规划的建议》，中国提出推动中医药传承创新发展，促进中西医协同应用。展望未来五年，他表示，中国可通过深化中医药在基层医疗和慢性病管理中的融合应用，建设面向公共卫生突发事件的科研平台，并充分运用数字健康技术，进一步巩固和扩大上述优势。

　　与此同时，他认为，提升中医药国际应用的质量，是其全球拓展面临的主要挑战。“这意味着，中国不应仅着眼于向海外输出中医药服务，更应积极参与并推动科学证据和监管标准的共建与共享。”他说，“如果缺乏清晰的监管框架，任何国家的卫生体系都无法负责任地将针灸和中医药纳入其医保或公共福利体系。”

　　拉蒙指出，当前的首要任务，是帮助各国在中医药整合之前建立完善的监管体系，包括明确专业资质认证、机构标准、安全规范和监督机制。他表示：“中国应与世界卫生组织以及跨洲学术机构携手，推动建立国际公认的中医药证据评价模式。”

　　“如果能够就如何开展中医药研究、如何解读相关证据达成共识，各国监管机构在决定将哪些中医药干预措施纳入公共卫生体系时，将会更加顺畅。”他说。

　　他还强调，重大海外中医药合作项目应与当地卫生主管部门保持长期沟通，使中医药发展与各国法律制度和医保体系相衔接。“如果中国能够将自身的临床与科研优势，与支持其他国家完善监管体系的清晰战略相结合，中医药就能够以渐进、安全、可持续的方式融入各国国家卫生体系。”拉蒙表示，“这不仅有利于提升人群健康水平，也将加强全球卫生合作。”

　　从长远来看，他认为，中医药的全球发展将因扎根于共同的科学研究、国际认可的标准以及互利共赢原则，而更具可持续性并获得更广泛的接受。

　　“在‘十四五’时期（2021—2025年），中国已经迈出了重要步伐。”拉蒙说，“接下来的挑战，是以更加开放、协作的方式深化这一路径，并以改善人群健康的可衡量成效为导向。”