How far is TCM from internationalization?

Authors: Liu Shujing, Li Chenshuo

The overseas innovative development of Chinese medicine is an important path to inherit and promote the excellent Chinese traditional culture, and it is also the core starting point for the implementation of the "going out" strategy.

01 The general trend: the national strategy promotes the opening of the all-round situation

1.

In recent years, as the modernization of Chinese medicine has become a national strategy, the internationalization of Chinese medicine has continued to be included in relevant national plans.

The top-level design promotes the development of Chinese medicine to the world with a larger scope, a higher level, and a deeper level

2.

On the one hand, the national strategy supports social forces in adopting a market-oriented approach to jointly build a group of friendly Chinese medicine hospitals and Chinese medicine industrial parks with countries with the potential and willingness to cooperate, and promote the open development of Chinese medicine

At present, China has built 32 overseas centers of traditional Chinese medicine and more than 40 international cooperation bases of traditional Chinese medicine along the “Belt and Road”

In addition, the role played by Chinese medicine in overseas anti-epidemic activities has had a positive impact on its internationalization

02 Accumulation of strength: internal tension promotes the acceleration of the pace of internationalization

1.

As the global acceptance of natural botanicals increases, the global Chinese medicine product market is developing rapidly

Figure 1: 2015-2019 export value of traditional Chinese medicine products (unit: 100 million U.

Source: Flint created and compiled from China Chamber of Commerce for Import and Export of Medicines and Health Care

2.

The ability to deploy overseas patents has been improved

Figure 2: The number of PCT applications for traditional Chinese medicine in the first half of 2012-2021 (unit: piece)

Source: Flint Creation Database

Speed ​​up the pace of drug registration in the US market

Table 1: Clinical trials carried out by some leading Chinese medicine companies in the United States

Source: Flint created and compiled from the National Institutes of Health

Deeply cultivate overseas mainstream markets

Vigorously develop the retail terminal layout

03 Bottleneck constraints: It is urgent to break through cultural differences, policy and technical barriers

1.
Cultural differences: there is a conflict between the unification of science and diversified cognition

The scientific and cultural concept of Chinese medicine has not yet been widely accepted by the global academic community.
The scientific diversification it represents, that is, the experience and knowledge gained from different cognitive methods and cultural practices have been upgraded to the concepts and expressions included in scientific theories.
The methods and evaluation criteria are diversified
.
At present, most people agree with the unified scientific standard with material as the center of cognition, which makes it difficult to accept the form of scientific knowledge of Chinese medicine
.

In addition, although TCM advocates that "the curative effect is the last word", the unique curative effect and scientific connotation of TCM as a medical science are gradually being recognized by more governments and people in the world, but how to prove the curative effect, whether it has sufficient truth Questions about data verification still need to be resolved
.
Just as traditional Chinese medicine has shown an active role in the prevention and treatment of the new crown epidemic, but it has not been widely recognized and used in the global fight against the epidemic, the main reason is the lack of evidence-based medical evidence
.

2.
Policy barriers: strict listing registration and certification system

Major developed countries adopt chemical drug requirements to manage the marketing registration of TCM drugs.
For example, Australia often registers TCM as registered (listed) drugs.
Different types of TCM products have different requirements and standards for their ingredients and indications.
The safety, quality and efficacy of registered drugs are subject to pre-market assessment by TGA (the agency that performs drug approval and supervision)
.
The FDA initially also required technical information such as the composition of the drug and the molecular formula of the drug for the declaration of traditional Chinese medicine
.
For traditional Chinese medicine, it usually includes a mixture of multiple ingredients, and the chemical composition and pharmacodynamic effects cannot be completely determined, which makes it difficult to obtain the recognition of the internationally registered drug market
.

In addition, the lack of systematic study of the relevant laws and regulations of overseas developed countries, especially the registration procedures, or the unfamiliarity with the corresponding rules and operating procedures are also the core challenges that domestic Chinese medicine companies encounter when entering overseas markets under the background of policy barriers
.

3.
Technical barriers: normative standards run through all links of planting, R&D and production

Developed countries overseas have set up high-threshold technical barriers, which run through all aspects of Chinese medicinal material planting, research and development and production of Chinese medicinal materials
.
Take Australia as an example.
If a pharmaceutical manufacturer wants to enter the country, it must obtain a Good Manufacturing Practice (GMP) certificate approved by the TGA.
At the same time, it requires that the production quality management of medicinal materials must have good clinical trial quality management practices (GCP) and Non-clinical drug research quality management practices (GLP) and other international standards
.
Traditional Chinese medicine companies must establish various standards that are in line with Australian laws and regulations in terms of dosage form, pharmacology, toxicology, and effective ingredients for planting management, processing and extraction, quality testing, pharmacological effects and toxicological evaluation of Chinese medicinal materials
.

04 A long way to go: multi-party joint efforts to deeply explore the value of traditional Chinese medicine

1.
Establish TCM standards that are in line with international standards

On the one hand, strengthen cooperation with international organizations such as the World Health Organization and the International Organization for Standardization, further clarify the role of evidence-based medicine in the development of Chinese medicine, and jointly explore unified standards suitable for the internationalization of Chinese medicine, including enterprise production standards, market approval standards, and quality testing standards and so on
.

On the other hand, it provides professional guidance for enterprises to help them familiarize themselves with overseas market product registration and market access policies and systems.
At the same time, it supports the establishment and revision of the industry standards of traditional Chinese medicine in the target market
.

2.
Create a collaborative Chinese medicine research pattern

Explore and initiate a major international scientific plan for Chinese medicine research, attract top talents from around the world, and carry out basic research on Chinese medicine treatment mechanisms and joint research on key common technologies
.
Support domestic leading Chinese medicine companies to set up overseas research and development institutions, cooperate with overseas top scientific research institutions and teams, and promote cooperation and development of Chinese medicine in overseas teaching and scientific research
.

3.
Support leading companies to build a world brand of traditional Chinese medicine

From the dimensions of technical strength, R&D capabilities, and overseas expansion potential, select a group of iconic Chinese medicine companies to increase support for talent introduction, R&D innovation, import and export trade, intellectual property protection, taxation, etc.
, and form a platform for Chinese medicine to sail abroad.
Demonstrate the driving effect, build a world brand of Chinese medicine, and lead and shorten the process of domestic Chinese medicine companies entering the international market
.

4.
Innovate the overseas dissemination model of Chinese medicine culture

The new crown pneumonia epidemic has further highlighted the value of traditional Chinese medicine on a global scale and has been further spread.
The report "Transformation of Chinese Medicine's Overseas Reputation under the Influence of the New Coronary Pneumonia Epidemic" released by the People's Daily Overseas Network shows that the role of Chinese medicine in China's fight against the epidemic The prominent role has attracted the attention of overseas media, and its value has been widely affirmed
.

Under this opportunity, on the one hand, we will strengthen overseas publicity, through systematic planning, and popularize Chinese medicine stories with the help of the media, overseas centers of Chinese medicine, and international cooperation bases of Chinese medicine; Overseas promotion and cooperative research and development, etc.
, promote the internationalization of Chinese medicine
.

references

[1] Song Yongjun, Liu Jianxun, Li Hao.
Australia Chinese medicine supervision and approval status and Chinese medicine product registration analysis [J].
China Modern Chinese Medicine, 2021, 23(05): 760-765.

[2] Mao Jialing.
China Traditional Chinese Medicine Culture and Industry Development Report (2017-2018) [M].
Social Science Literature Publishing House, 2019.

[3] China Pharmaceutical Innovation Promotion Association, Pharmaceutical Research and Development Industry Committee of China Association of Enterprises with Foreign Investment.
The first series of reports on the construction of China's pharmaceutical innovation ecosystem: 2015-2020 development review and future prospects [EB/OL].
[2021-3-2].

http:// National Institutes of Health (NIH): ClinicalTrials.
gov.