Drug Discoveries & Therapeutics. 2024; 18(4):210-212.

Editorial

210

DOI: 10.5582/ddt.2024.01055

Tailored to fit: China optimizes policies and regulations regarding
drug registration and review to promote innovation in traditional
Chinese medicine
Daoran Lu1, Fangzhou Dou1, Fanghua Qi2, Jianjun Gao1,*1
2

Department of Pharmacology, School of Pharmacy, Qingdao University, Qingdao, Shandong, China;
Department of Traditional Chinese Medicine, Shandong Provincial Hospital affiliated with Shandong First Medical University, Ji'nan, Shandong,China.

SUMMARY

The classification system for drug registration and the review and approval process influence theinnovation and development of pharmaceuticals. China's previous classification standards forregistration of traditional Chinese medicines (TCMs) overly emphasized the material basis whileneglecting the clinical value of TCM. Moreover, the review and approval system did not fully consider
the characteristics of new TCM drugs, such as the clinical experience already available for many
TCM formulations guided by TCM theories. This resulted in suboptimal quality and quantity in thedevelopment of new TCM drugs. Since 2019, China has introduced a series of policies and regulations
aimed at reforming the classification system for registration of TCMs and establishing a review system
tailored to TCM characteristics. The new classification system for registration of TCMs emphasizes
that the development of new TCM drugs should be oriented towards clinical value, focusing on
meeting unmet clinical needs. The policies and regulations promote the conversion of prescriptions inancient classics into new drugs and encourages the conversion of preparations from medical facilities
into new TCM drugs. Secondary development of already marketed TCM products is encouraged toenhance the advantages of their clinical use. The new review system places importance on the roleof TCM theories and clinical experience in supporting the registration of new TCM drugs. These
reform measures have paved a path for registration and review of the characteristics of TCMs and will
positively promote the development of new TCMs.

Keywords

traditional Chinese medicine, registration, classification, policy, regulations

Traditional Chinese medicine (TCM) is a treasureof the Chinese nation, having made enormous
contributions to the health and well-being of theChinese people over thousands of years. Comparedto modern medicine, TCM has a unique theoreticalsystem and plays a distinct role in maintaining andpromoting people's health. It has particularly notableadvantages in the treatment of specific conditions andspecialties such as orthopedics, proctology, pediatrics,dermatology, gynecology, cardiovascular diseases,
kidney diseases, and peripheral vascular diseases.
During the fight against the COVID-19 pandemic,
TCM gained significant attention for its ability toeffectively alleviate symptoms, reduce the progressionof mild cases to severe cases, increase cure rates, andpromote the recovery of individuals in the convalescentphase (1). Despite this, the development of innovative
TCM drugs faces several challenges and issues. As anexample, the classification of TCMs for registration is
not sufficiently rational, leading to an overemphasison the material basis while undervaluing their clinicalsignificance. In addition, the policies and regulations
related to the review and approval process areincomplete, causing suboptimal quality and quantity inthe development of new TCMs.
In October 2019, the government issued theOpinions on Promoting the Passing Down, Innovation,
and Development of Traditional Chinese Medicine(2). Addressing various issues and deficiencies inthe development of TCM, such as an incomplete
TCM care system, inadequate supply of quality
TCMs, the shortage of skilled personnel, an imperfectinnovation system, and lack of prominent development
characteristics, the document proposed comprehensive
requirements for reform. In promoting quality drug
development, the document emphasized optimizing

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Drug Discoveries & Therapeutics. 2024; 18(4):210-212.

the management of TCM evaluation and approval andrefining the management of TCM classification andregistration. Revised Measures for the Administrationof Drug Registration in China were promulgatedin January 2020, introducing a new, more rationalclassifications for TCM registration (3). In September
2020, detailed classifications for TCM registration andcorresponding application requirements were issued by
the National Medical Products Administration (NMPA)(4). In February 2023, the NMPA issued the Special
Provisions for Registration of Traditional Chinese
Medicines, which further refined the requirements forTCM research and development based on the generalprovisions of drug registration management (5). Thisenhanced the management of the development andregistration of new TCMs.
After the reform, the system to manage drugclassification categorizes TCM registration into fourtypes: innovative TCMs, improved TCMs, TCMs
in ancient classics, and drugs with the same nameand formula (4). The first three categories fall under
the scope of new TCMs. Innovative TCMs include
preparations of Chinese herbal medicines, extracts,
and preparations obtained from single plants, animals,minerals, etc., as well as new herbal materials andtheir preparations (4). Improved TCMs modify theadministration route or dosage form of existing
marketed TCMs, with advantages and characteristics
in terms of clinical use such as enhanced therapeuticfunctions or new indications (4). TCMs in ancientclassics refer to formulas recorded in ancient TCM
classics that are still currently widely used with provenefficacy, distinctive features, and advantages (4). Unlike
the previous classification system for registration ofTCMs that emphasized the material basis for innovationin TCM, the revised system underscores that thedevelopment of new TCM should be guided by clinicalvalue (5). It emphasizes assessing clinical benefits andrisks, capitalizing on the unique advantages of TCM
in disease prevention and treatment, and addressing
unmet clinical needs. The strategy for developing novel
TCMs focuses on promoting research and developmentof preparations based on TCM formulas in ancientclassics and encouraging the conversion of preparations
from medical facilities into new TCMs (5). Secondary
development of existing marketed TCMs is encouraged
to enhance the advantages of their clinical use (5).
Another highlight of the reform is the emphasison the support role of TCM theories and clinicalexperience in the registration of new TCMs. Unlike
chemical drugs, Chinese herbal medicines areoften clinically used to treat related diseases before
registration. Therefore, the policies and regulations
emphasize the supporting role of clinical experiencein the safety and effectiveness of TCMs. During
the registration and approval process, an integrated
system for evaluating evidence that combines TCM

theories, clinical experience, and clinical trials is usedto comprehensively assess the safety, effectiveness,and quality controllability of TCMs (5). A point worth
noting is that preparations based on TCMs in ancientclassics generally do not require clinical trials (5).
The approval of these new TCMs mainly relies on theopinions of experts (5). This reform reflects respect
for the clinical use of TCM formulas from ancientclassics in TCM practice and highlights the academic
inheritance and clinical characteristics of TCM. For
other new TCMs used in clinical practice, if clinicalexperience can provide supporting evidence in termsof clinical positioning, patient selection, considerationof the duration of treatment and dosage, etc., suchmedicines may skip Phase II clinical trials but generally
require Phase III clinical trials to confirm the safety andefficacy (5). In contrast, if the development of a newTCM is based on studies involving pharmacologicalscreening rather than TCM theories and clinicalexperience, necessary Phase I clinical trials should beconducted, followed sequentially by Phase II and Phase
III clinical trials (5). These reform measures open up aregistration and evaluation pathway that considers thecharacteristics of TCM.
Compared to modern medicine, TCM has its own
characteristics regarding indicators of efficacy andmethods of assessment. The effectiveness of TCM is
not only reflected in the improvement of indicators of
disease pathology but also in the improvement of TCM
syndromes. Therefore, assessment of the efficacy of
TCM can now involve a combination of diseases andsyndromes (5). TCMs can be classified into three specificcategories based on their therapeutic indications (5): (i)Syndrome-based TCMs: These are formulations guided
by TCM theories to specifically treat TCM syndromes.
Their therapeutic functions and indications are describedusing TCM terminology. (ii) Combined diseasesyndrome-based TCMs: These address both modern
medical diseases and TCM syndromes. Their indications
are described in terms that combine modern medical
diseases and TCM syndromes. (iii) Disease-based TCMs:
These are medications for specific modern medical
diseases formulated in accordance with TCM theories.
Their therapeutic functions are described using TCM
terminology, while their indications are based on modern
medical diseases. In clinical trials, the assessment ofefficacy should be based on corresponding indicators of
disease pathology or TCM syndromes, fully reflecting
the unique characteristics of the efficacy of TCMs.
Establishing methods of evaluating safety and efficacy
and technical standards that align with the characteristics
of TCM is a goal of the reform.
In response to specific situations in clinical use ofTCM, recent policy reforms have clarified the criteria for
implementing priority review and approval, conditional
approval, and special approval. (i) Priority review andapproval: TCMs that have clear clinical positioning andwww.ddtjournal.com

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significant clinical value and that are used to treat majordiseases, rare diseases, clinical emergencies as a resultof market shortages, or for pediatric use are eligible
for priority review and approval (5). (ii) Conditional
approval: TCMs to treat diseases that are life-threatening
and for which no effective treatment is available may
be conditionally approved if clinical trial data or quality
clinical experience with the TCM indicates its efficacy
and predicts its clinical value (5). (iii) Special approval:
TCMs already on the market that require additional
indications to address urgent needs during sudden major
public health emergencies may undergo special approval
to expand their therapeutic indications (5). These
reforms aim to streamline the regulatory processes forTCMs, ensuring timely access to effective treatments
for critical medical conditions and public healthemergencies.
In order to fully capitalize on the advantages of thehealthcare security system and support the innovationand development of TCM, the National Healthcare
Security Administration and the National Administrationof Traditional Chinese Medicine jointly issued theGuiding Opinions on Medical Insurance Supporting
the Passing down, Innovation, and Development ofTraditional Chinese Medicine in December 2021 (6).
This guidance includes coverage of suitable TCMs
by health insurance payments. In order to enhance
the full lifecycle management of TCMs and promote
continuous improvement in their quality, the NMPA
drafted the Regulations on Protection of Traditional
Chinese Medicine Varieties (Draft for Public Comments)
in December 2022 and solicited public opinions (7).
These policies and regulations comprehensively andsystematically create a TCM management system inorder to positively promote the development of newTCMs.

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Received July 15, 2024; Accepted July 18, 2024.

Funding: None.

*Address correspondence to:
Jianjun Gao, Department of Pharmacology, School ofPharmacy, Qingdao University, Qingdao, Shandong, China.
E-mail: gaojj@qdu.edu.cn

Conflict of Interest: The authors have no conflicts ofinterest to disclose.

Released online in J-STAGE as advance publication July 20,2024.

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