The Asia-Pacific region is home to a diverse array of traditional medicinal practices. The region is also rich in a large and diverse population. This diversity includes genetic variations, dietary patterns, environmental factors, and disease profiles, which makes trial results more applicable across global populations. Moreover, the growth of research facilities presents opportunities for sponsors to build and expand upon the knowledge gained from hundreds of years of traditional medicine. Together, these strengths position Asia-Pacific as the ideal region for clinical trials on traditional medicine.

Traditional medicine in the Asia-Pacific region has deep historical and cultural roots. Systems such as Ayurveda in India and Traditional Chinese Medicine (TCM) in China have evolved over thousands of years. These practices are not only healthcare methods but also considered expressions of cultural identity and philosophy. 

Today, traditional medicine remains central to the healthcare regime for millions in the region. Many governments recognize and regulate it as part of national health policy. Traditional medicine in the Asia-Pacific serves as a link between heritage and modern science, while continuing to adapt and preserve its ancient wisdom.

What are traditional medicines?

WHO defines traditional medicine (TM) as healthcare systems developed before modern biomedicine. These systems include practices, knowledge, and philosophies from diverse cultural contexts. TM focuses on natural remedies and holistic approaches. It focuses on restoring balance between the mind, body, and environment. Over time, these practices have evolved continuously through experience and continue to adapt with modern science.

Major traditional medicine systems in the Asia-Pacific region and their practices are listed below:

Traditional Medicine System	Country of Origin	Specific Practices
Ayurveda	Indian subcontinent	Herbal remedies, diet, yoga, focus on balancing mind, body, and spirit
Traditional Chinese Medicine (TCM)	China, East Asia	Herbal medicine, acupuncture, massage (tui na), exercise (qigong), and dietary therapy
Kampo	Japan	Holistic diagnosis, decoctions, herbal therapy, aroma therapy, dietary supplements, and acupuncture
Traditional Korean Medicine (TKM)	Korea	Acupuncture, herbal medicine (Hanyak), and moxibustion to promote overall health by balancing the body
Sowa Rigpa	Bhutan	Herbal medicine, behavioral modification, acupuncture/acupressure, and spiritual healing
Jamu	Indonesia	The consumption of Jamu, the use of specialized traditional healers called dukun, and traditional Karo medicine
Thai Traditional Medicine (TTM)	Thailand	Herbal medicines, bodywork, and spiritual healing methods
Ya Phurn Meuang Lao	Laos	Combines herbal remedies with spiritual practices, shaped by influences from Buddhism, Sino-India, and ancient Khmer traditions
Traditional and Complementary Medicine (T&CM)	Malaysia	Incorporates various practices, including traditional Malay, Chinese, and Indian medicine
Đông Y/Vietnamese traditional medicine	Vietnam	Herbal remedies, non-herb practices like cạo gió (wind scraping) and giác hơi (cupping), and the use of other traditional methods such as acupuncture, massage, and bloodletting
Taing-yin Hsay Pyinnya	Myanmar	The Desana system (based on the balance of natural elements like hot and cold), and the Bhesajja (Ayurvedic) system (based on balancing the three doshas using herbal and mineral compounds)
Folk medicine	Phillipines	Herbal remedies, spiritual healing, and physical manipulation techniques

Why are clinical trials required for traditional medicinal products?

Clinical trials aim to establish scientific validation by verifying traditional claims through the collection of reproducible data. They assess how treatments work, identify safety concerns, and measure therapeutic outcomes under controlled experimental conditions. 

Regulatory bodies across the Asia-Pacific increasingly require scientific evidence before approving products for the market. Many countries are aligning their frameworks with international standards such as ICH-GCP. This is why traditional medicine products can gain acceptance both regionally and globally while ensuring patient safety.

The following table enlists country-wise regulatory bodies and the guidelines for clinical trials on traditional medicinal products:

Country	Regulatory Authority	Key Guideline(s)
China	The Center for Drug Evaluation (CDE), under NMPA	Requires non-clinical safety data, human use experience, and clinical trial evidence that comply with GCP standards.
Republic of Korea	Ministry of Food and Drug Safety (MFDS / KMFDS)	Clinical Trial Authorization (CTA) application to the KMFDS, who then review the trial protocol, safety, efficacy, and data quality.
India	Ministry of AYUSH / Indian Council of Medical Research (ICMR) / Central Drugs Standard Control Organization (CDSCO)	All clinical trials must be registered with the Clinical Trials Registry- India (CTRI) to ensure transparency and compliance.
Singapore	Health Sciences Authority (HSA): Clinical Trials Overview; Traditional Medicines regulatory overview	The Traditional Medicines are not subject to pre-marketing approval/licensing by HSA but must meet safety/quality standards.
Australia	Therapeutic Goods Administration (TGA), Australian Regulatory Guidelines for Complementary Medicines (ARGCM)	Herbal and traditional medicine clinical trials require an Investigational New Drug (IND) application submitted to the FDA. Trials must comply with US GCP and Belmont Report ethical standards.
Japan	The Pharmaceuticals and Medical Devices Agency (PMDA). It operates under the Ministry of Health, Labour and Welfare (MHLW)	Clinical trials require submission of a Clinical Trial Notification (CTN) to the MHLW/PMDA. Trials for new drug applications must comply with Japanese GCP, the Pharmaceuticals and Medical Devices Act (PMD Act), and the Clinical Trials Act.
The USA	Food and Drug Administration (FDA)	Herbal and traditional medicine clinical trials require an Investigational New Drug (IND) application submitted to FDA. Trials must comply with US GCP and Belmont Report ethical standards.
Europe	European Medicines Agency (EMA), National Competent Authorities	Applicants must demonstrate at least 30 years of traditional use (15 of which in EU), with well-established safety and efficacy, or provide supporting clinical data.

Why does the Asia-Pacific region lead in traditional medicine clinical research?

The Asia-Pacific region combines centuries-old traditional medicine practices with modern clinical research capabilities. This combination of ancient knowledge and scientific infrastructure has made APAC a global leader in traditional medicine research. The region offers sponsors an ideal setting for clinical trials that connect traditional healing wisdom with modern scientific standards.

In the next section, we’ll look at the key factors that make the Asia-Pacific well-suited for traditional medicine research.

1. Large, diverse patient pool 

• APAC, home to 60% of the world’s population, offers unmatched potential for strong clinical research data.
• Its diverse genetic background provides a strong foundation for collecting heterogeneous clinical datasets. This enhances the accuracy and applicability of research outcomes.

2. Cultural relevance and patient acceptance 

• APAC countries show strong cultural trust in traditional practices like acupuncture, herbal medicine, and Ayurveda. Hence the reason why it drives high patient recruitment, enrollment, and retention in clinical trials.
• Ethical and philosophical alignment between treatment approaches and patient beliefs improves adherence and data reliability. The deeply embedded traditional medicine in healthcare practices in APAC, further creates no ethical conflicts. A few examples are acupuncture and moxibustion, which are accepted therapies in countries like Korea, China, the Philippines, and beyond.

3. Cost-effectiveness 

• The APAC region offers lower operational and patient-recruitment costs than the West. This makes traditional medicine clinical trials more economically feasible.
• For instance, Australia’s Research and Development Tax Incentive reduces costs by up to 40% compared to the U.S.
• Furthermore, this financial feasibility supports trials that require large sample sizes or extended observation periods typical of traditional medicine research.

4. Advanced research infrastructure 

• Many countries in the APAC region (China, India, South Korea, Japan, and Singapore) have well-established clinical trial units and research centers dedicated to traditional medicine.
• According to recent data reported in the literature, researchers in China registered nearly 1,000 clinical trials of new traditional Chinese medicines from 2013–2021.
• In Korea, teams use advanced digital tools to strengthen trial data integrity.

5. Regulatory support and government initiatives

• Governments in APAC actively promote traditional medicine clinical research via national policies, institutional support, and registries such as the International Traditional Medicine Clinical Trial Registry (ITMCTR).
• The China-ASEAN Joint Laboratory is a great example of countries partnering to improve traditional medicine research and align regulations.
• The Global Centre for Traditional Medicine was established by the WHO in Jamnagar, Gujarat, India, in 2022 to promote traditional medicine for treating ailments. 

6. Collaborative networks

• Traditional medicine institutes are increasingly collaborating with modern clinical research networks and universities in the APAC region to improve study design, oversight, and data integrity.
• These partnerships, as such, bring rigorous methodologies, standardized protocols, and robust monitoring to traditional medicine trials. 
• Also, such integration strengthens the credibility of research findings and facilitates global publication and regulatory submission.

These advantages make APAC uniquely positioned to conduct high-quality clinical trials in traditional medicine and herbal medicine. APAC offers strong conditions for traditional medicine research. However, researchers must address key challenges to ensure successful trials. We discuss these challenges in the next section.

Conducting clinical trials on traditional medicinal products: Challenges and mitigation strategies

Traditional medicines combine complex herbal formulations, varied practices, and unique outcomes.
These unconventional endpoints create major challenges for clinical trial teams. The challenges could include designing a study, standardization, resource, and regulatory-related difficulties, among others. These are discussed in detail below: 

Challenges for conducting clinical trials on traditional medicinal products

1. Methodological barriers: 

• Creating a placebo that looks and feels like the herbal product is difficult. There are also challenges in making sure the product quality is the same from one batch to the next. Additionally, using traditional trial designs, such as blinding, can be tricky. 
• Another challenge could be deciding on clear inclusion and exclusion criteria based on different medical beliefs. This makes it hard to find a similar group of study participants.  

2. Need for harmonization and global recognition of TM clinical data:

• Regulatory frameworks for traditional medicine vary widely across countries. These differences create inconsistencies in trial design, data standards, and approval pathways. 
• The absence of uniform definitions, such as distinguishing “traditional medicines” from “herbal medicinal products,” further complicates global acceptance and data comparability.

3. Limited clinical research capacity in some regions: 

• Uneven distribution of GCP-compliant sites and trained investigators exists across the region, particularly in rural or emerging markets where TM use is most prevalent. Limited infrastructure and funding further slow trial initiation and execution.

4. Protocol and practitioner standardization:

• Traditional medicine systems rely heavily on practitioner interpretation, which can lead to variability in diagnosis, patient management, and data collection across sites.

However, to address these challenges, sponsors can implement the following strategies:

1. Utilize local traditional-medicine expertise:

The Asia-Pacific region has extensive experience in herbal medicine formulation. This includes skilled practitioners of Ayurveda, Traditional Chinese Medicine, Siddha, and Kampo. Thus, with the help of their indigenous knowledge, these practitioners can guide the development of placebos of desired quality. 

2. Adopt strict quality, manufacturing, and analytical standards:

Sponsors need to apply good manufacturing practice (GMP) and good agricultural and collection practice (GACP) while conducting clinical trials on TM.  Quality control needs to be maintained with validated analytical techniques such as HPLC, GC, and GC-MS. Regulatory guidelines often require these standards for clinical data acceptance and dossier submission.

3. Identify APAC sites with both traditional medicine knowledge and trial infrastructure:

It is recommended to select sites with the right infrastructure, regulatory fit, and traditional medicine capability. APAC offers growing site networks with both modern trial experience and traditional medicine knowledge. And hence, sponsors can partner with regional CROs and academic institutions to access trained investigators, shared infrastructure, and ethically aligned trial practices. 

4. Standardise diagnostic frameworks and protocol manuals:

Develop comprehensive practitioner manuals that clearly define how traditional diagnoses correspond to study outcomes. Also, it is a good practice to create SOPs that detail exactly how to administer traditional therapies, including dosage, timing, and delivery.

5. Establish clear inclusion and exclusion criteria:

Designing an inclusion/exclusion criteria that work within both traditional and conventional diagnostic frameworks ensures participant selection is consistent across all study sites. Moreover, emphasize providing thorough training to all practitioners involved in the trial to ensure they follow the same protocols and assessment methods. 

Conclusion

The Asia-Pacific region offers unique advantages for traditional medicine clinical trials. Its cultural acceptance, diverse populations, cost efficiency, and modern infrastructure create ideal conditions for quality research. While methodological and regulatory challenges exist, they can be overcome through strategic planning and collaboration. Hence, by addressing these complexities, researchers can validate traditional therapies and integrate ancient healing wisdom into modern, evidence-based healthcare.

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