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CTMJ | traditionalmedicinejournals.com Chinese Traditional Medicine Journal | 2024 | Vol 7 | Issue 1 

 

  
 

    ISSN: 2693 6356 

2024 | Vol 7 | Issue 1 
 
 

 

Integrating traditional Chinese (herbal) medicines into risk-based 

regulation - With focus on non-clinical requirements to demonstrate 

safety 

Vivian Liu. nqan Fung 

Independent Scholar, 2 Woodward Place, St Ives, NSW, 2075, Australia 
 

Keywords: 

Proprietary and traditional Chinese herbal medicines 

Internationalization Nonclinical 

Drug regulation and registration reform Certificate of pharmaceutical product 

 

Introduction: 

Chinese herbal medicines was gained in the last 
decade. Yet, after ten years of growth, a 
negative growth in the value of TCM as im- 
ports and exports was reported in China for the 
first time.2 It is believed that among all the 
barriers, differences in the standards of 
evaluation accepted by drug regulation 
authorities including: the 
definition/classification of herbal products, 
paths of market entry, Good Manufacturing 
Practices (GMP) compliance, and evidential 
requirements for demonstrating efficacious 
and safe use based on product history non-
clinical and clinical studies, are key elements 

that hampered the internationalization of 
TCM.3 

These inconsistencies in drug evaluation standards do 

not merely have an impact on how a pharmaceutical 

manufacturer strategizes their worldwide registration 

plan, but can potentially cause misinterpretations that 

result in inappropriate assessment of herbal products. In 

countries that are dependent on Certificate of 

Pharmaceutical Product (CPP),1 herbal products may be 

used as medicines even when the product has not been 

assessed as a medicine. Such countries accept the review of 

scientific and clinical dossiers from CPP issuing countries as 

quality assurance that the medicinal products they 

imported meet a stipulated acceptable level of safety and 

health in their healthcare sector.4 

Depending on the criteria set by different authorities, a 

herbal product considered to be a dietary supplement and 

regulated as a 

food product in one country, may be considered as food 

supple- mint, a therapeutic good (complementary medicine 

or prescription medicine) or even a substance in another 

jurisdiction. For example, while melatonin is regulated in the 

 

      Abstract—  

All parties involved in Hong Kong's (China) public health system agree that TCM plays a significant 

role. The government, academic institutions, and industry of Hong Kong (China) must work together 

if the city is to play a pivotal role in exporting Chinese pharmaceuticals to international markets. The 

opportunity for well-established and traditional herbal medicines to demonstrate a 'acceptable safe' 

status for registration in the European Union has been opened up with the release of the final version 

of the European Medicines Agencies guidance document. This document details the acceptance of 

minimum requirements to nonclinical packages in bibliographical applications. Regardless of whether 

they are eligible to be registered under the streamlined approach inside the European Union, many 

traditional Chinese medicines may be shown to be safe to use with this basic nonclinical package. For 

qualifying proprietary Chinese medicines (pCm) with a long history of usage, this article envisions 

integrating a streamlined assessment method into the current drug regulatory system in Hong Kong 

(China). Less demand for scientific resources is required for such integration that uses the minimal 

nonclinical package based on bibliographical data or expert reports to prove safety for pCm with a 

lengthy history of usage. 'First hand' evaluation in Hong Kong (China) for qualifying pCm gives local 

and international pharmaceutical businesses an alternative to relying on Certificate of Pharmaceutical 



 

 

CTMJ | traditionalmedicinejournals.com Chinese Traditional Medicine Journal | 2024 | Vol 7 | Issue 1 

United States (US) as a dietary supplement, it is a national 

health product in Canada and a prescription medicine in  

 

  
Australia.5 Dehydroepiandrosterone (DHEA) is readily 

available as a dietary supplement in the US, while in many 

other jurisdictions it is regulated as a controlled sub- stance.5 

This heterogenicity in how CPP issuing countries define 

herbal products poses a concern to CPP dependent countries 

as some drug regulatory authorities in CPP issuing countries 

require few or less stringent registration requirements. As a 

result, the same herbal products can be marketed in a 

different category in different countries with a CPP, resulting 

in potential safety issues for the public’s health.6,7 

 
Safety, quality and efficacy of traditional Chinese and 

herbal medicines 

controlled 
As a result of the prevalence of poor scientific studies on 

Chinese herbal medicines and the lack of a systematic 

investigative approach in the past, medical professionals 

have been concerned about their efficacy and safety.8 Over 

the past decade, with the support from the Chinese 

government, the Chinese clinical trial registry was set up to 

ensure clinical trials are conducted based on international 

standards and with higher quality.9 This allows the 

anticipated effectiveness of TCM to be verified with means of 

proper understanding by Western countries. 

Safety continues to be an essential attribute in the 

pharma- ceutical industry. There is a common misconception 

by the public that natural means safe and that herbal 

medicines are harmless.1 It is however, the inherit risk of an 

herb itself that contains unknown toxic compounds, albeit 

low, do exist. The lack of regulatory registration/evaluation 

based on international risk-based standard limits the safe 

control/use of herbal medicines.10 Hence incidents on 

overdosing (since safe levels of intake from dose-response 

data may not be established), adverse health effect caused by 

drug interaction or loss of efficacy continue to happen when 

common herbal medicines are taken together.11 

Manufacturing errors, in which one herb is mistakenly 

replaced with another or being contaminated with other 

undeclared plant and animal material, heavy metals (such as 

arsenic, lead, and cadmium), pesticides, microorganism or 

toxic compounds are not uncommon. Cases of adulteration 

have also been reported, Western medicines (such as the 

blood-thinner warfarin and the non-steroidal anti-inflamma- 

tory agent diclofenac) were mixed with herbals to enhance 

their 
efficacy. These resulted in serious complications including 
organ 
damage.10e13 

It is unquestionable that stringent requirement should 

apply to registration of any medicinal products with new 

herbal substances/ herbal preparations. There is a 

desire among the medical community for a full evaluation 

of new herbal products. Compre- hensive, thorough 

evaluation for new herbal medicinal products to ensure good 

set of quality, safety and efficacy (QSE) should be conducted 

like Western medicines with new chemical entities. However, 

if herbal medicinal products of long history of use are 

considered as ‘new’ medicines and the same stringent 

registration process applied, it inevitably hampers the 

interest of pharmaceu- tical companies to register and 

market their products globally. The hesitation in recognizing 

the long history of clinical experience for traditional Chinese 

and herbal medicines as evidence of safety has long limited 

the growth of TCM globally. 
To combat this, a tailored approach to register traditional 
and 

herbal medicinal products involving dossiers that 

incorporate long standing evidence of safety and efficacy 

has long been considered.14 The need for better quality 

assurance in drug development has been of focus for years. 

It is recognized that in view of the complexity of quality 

assurance of herbal medicines and that long history of use 

do not represent products with good quality. To achieve 

quality assurance, a comprehensive quality dossier and 

other common fundamental principles including GMP must 

be provided. Pharmacovigilance should always be required 

regardless of the life history of an herbal medicinal 

product.15 However, for safety and efficacy dossiers, a 

simplified version could be consid- ered acceptable. It is 

important that no consumption of medicines should cause 

harm. Good safety profile of any medicinal product is an 

expected feature and has grown in its importance over proof 

of efficacy in the past years.16 Between safety and efficacy 

data, the requirements in nonclinical safety testing is 

relatively less certain. The basic goals of a comprehensive 

conventional nonclinical studies package in drug 

development include, identifying the pharmacological 

properties in the establishment of comparative physiology 

between animals and humans, calibrating the safe initial 

dose permissible for first human exposure, and identifying 

the biological markers that predict potential adverse effects 

for clinical monitoring. There is a general acceptance that 

some of the 
above unknowns are indeed addressed or partially 
addressed in 

herbal medicals due to a long history and prevalence of 

use.14 This is the basis of the tailored approach. 

Much effort has been made to modernization of TCM 

world- wide. For example, in 2004, through Directive 

2004/24/EC, the registration procedure for traditional 

medicinal products was simplified. It is based on 

submission of full quality dossiers sup- ported with 

bibliographical data or expert report on well- established 

or traditional applications of herbal medicines respec- 

tively.15 Legislations regarding herbals by the European 

Union (EU) in 2011 and the Traditional Herbal Registration 

Scheme in the United Kingdom further strengthened the 

quality of herbal prod- ucts to pharmaceutical quality 

standards.17 Some regulatory bodies including the US Food 

and Drug Administration (USFDA) have placed special 

emphasis on batch-to-batch quality and therapeutic 

consistency.3 In China, enormous efforts are dedicated in 

advancing as well as consolidating TCM’s scientific 

grounding and clinical practice. The international 

community have also contributed on- going collaborative 

works such as the ‘Herbalome Project’ which aims to 

examine mainstay TCM formula and Chinese herbs for their 

structure, function and chemical composition.18 The project 

helps to establish the resource library and contribute to the 

World Health Organization (WHO)’s classification on TCM. 

In 2018, the WHO revealed that by 2022, TCM would be 

included in its 11th revision of the International Statistical 

Classification of Diseases and Related 
Health Problems, a document that offers standardized 
diagnostic 

classification for clinical and research purposes19.As noted 

earlier, different classification categories are used in herbal and Chinese medicines, the terms ‘established’ and 



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‘traditional’ for herbal medicine use in EU20 can be 

different from those use in other 

countries, such as Hong Kong (China),21 therefore, care should 

be taken as different registration requirements apply.22 

In 2019, the European Medicines Agencies finalized 

guidelines for documenting herbal medicines of well-

established use or traditional origins in non-clinical ways. It 

reaffirms its acceptance of the waiving of a thorough 

toxicological assessment with the 

minimum package, and hence encourages more eligible 

herbal medicines to reach international risk-based 

standard.16,23 Included in this guideline are herbal medicines 

that have seen well- established usage EU-wide for the 

minimum of 15 years or in traditional medicinal use for a 

minimum of 30 years, including 15 years within the EU.20 It 

provides guidance on the minimum nonclinical package to 

demonstrate ‘acceptably safe’ for EU regis- tration purposes. 

The document recognized that human experience with 

traditional herbals of long usage history may obviate the need 

to conduct acute and chronic toxicity tests. However, this does 

not apply to reproductive toxicity, genotoxicity and 

carcinogenicity tests. It is because these areas of major concern 

can only be dealt with through careful conduct of nonclinical 

studies. The minimum nonclinical package for the simplified 

registration consists of: 

 
1. General aspects, including investigation of the effects on 

drug metabolizing enzymes 

2. In vitro and in vivo genotoxicity assays 

3. Long-term rodent carcinogenicity (for products intended to 

be continuously used for >3 months or intermittently for 

>6 months) 

4. Reproductive and developmental toxicity (for products used 

by women of childbearing age) 

 
The package takes into consideration the frequent use of 

herbal medicines in conjunction with conventional Western 

medicine, therefore making clinical and kinetic interaction 

major areas of concern. Drug interaction studies to investigate 

the effects on drug metabolizing enzymes, as mechanistic and 

genetic evidence, are key nonclinical studies in herbal 

medicines registration. This in- cludes identifying cytochrome 

P450 enzyme involved, lower sig- nificant interaction and 

potential genetic issues.24 

Special toxicity studies, like the genotoxicity assays, are 

needed because it allows early identification of potential 

carcinogenic to human. In combination with long history of 

clinical experience, this non-clinical package provides an 

acceptable safety profile for sub- chronic use of traditional 

herbal medicines. For those that request for specific targeted 

therapeutic indications or have demonstrated cause for 

concern, test on carcinogenicity and/or reproductive/ 

developmental toxicity may be required.23 

There are still many herbal products not registered within 

the EU since the introduction of the simplified procedure in 

2014,17 with the minimum nonclinical package being finalized, 

it is antic- ipated that this refined simplified procedure will 

further promote safe use of traditional herbal products and 

enable free EU-wide movement.15 

 
Opportunities and challenges for Hong Kong (China) in 

internationalization of TCM 

 
In Hong Kong (China), TCM is a vital part of the mainstream 

medicinal consideration. Conjunctive use of Western drugs and 

TCM are commonplace within the Hong Kong (China) public.25 

With the drive from the Hong Kong (China) Government and the 

increase in consumer demand worldwide, Hong Kong (China) is 

placed with the opportunity to lead the internationalization of 

herbal products and the challenge to preserve their therapeutic 

value as medicines. 

Government and businesses are the main drivers for 
regulatory 

reform. Strong policy drivers are core factors in translating 

idea into practice. Resistance to policy changes tends to be 

high when stakeholders and users are confused with how 

the changes may affect them and whether the changes 

would be positive. 

Hong Kong (China) is well positioned in creating a good 

envi- ronment for the growth of TCM globally. The Hong 

Kong (China) Government has already set key initiatives to 

develop TCM. This includes promoting research, clinical 

TCM practice and conducting clinical trials in China. The 

setup of the first Hong Kong (China) Chinese medicines 

hospital will further support the established academic 

exchange allowing more local TCM trainee to gain first- 

hand experience from TCM practitioners in China.26,27 

Implementation of new regulatory measures is complex. 

Early stakeholder engagement, including community, 

industries, in- stitutes and affirmative financial support are 

crucial to a successful reform. The benefit of promoting 

Hong Kong (China) to be a TCM hub, including having early 

access to Chinese medicines and enhancement of import 

and export trade business need to be communicated early. 

Concerns, including the high cost incurred for complying 

with the requirements for providing the QSE of Chinese 

medicines should also be addressed. Financial support 

assisting licensed TCM manufacturers in conducting safety 

tests and re- searches could be promoted. 

It is recognized that language is a barrier in promoting 

TCM globally. Translating scientific information of Chinese 

medicine is paramount in this amalgamation.3,28 Only a 

miniscule portion of this tradition has been translated in 

English. The theory of Chinese medicine functions on a 

different paradigm to that of modern sci- ence and cannot 

be fully captured within its context or discourse. It requires 

of the translator an intimate knowledge of the subject 

matter at hand.28,29 The sociocultural context of Hong Kong 

(China) is influenced by the convergence of East and West. 

It has the advantage of having Chinese being the national 

language and has inherited the cultural and philosophical 

understanding of TCM direct from the People’s Republic of 

China.30 

As a Special Administrative Region, Hong Kong (China) 

has the advantage of having a different pharmaceutical 

regulatory system from the People’s Republic of China. The 

regulation of TCM in Hong Kong (China) is also separated 

from its Western medicines. This provides the flexibility for 

Hong Kong (China) to make policy changes in developing 

new registration process for Chinese medi- cines without 

affecting the existing system for both Chinese and Western 

medicines. 

To maintain a creditable system, a scientific approach 

when making policy changes in regulating Chinese 

medicines must be maintained. Product assessment and 

registration is a major step for marketing and to ensure 

pharmaceutical products meeting appropriate standards of 

QSE. Drug regulation process is complex and resource 

intensive. Limitation in scientific and clinical exper- tise and 

resources is not uncommon in Asian countries. In 

Singapore, the national drug regulatory agency, Health 

Sciences Authority managed this limitation by engaging 

both internal and external evaluators. It further adopted a 



 

 

risk based approach by implementing a full registration 

process with three evaluation routes for Western 

medicines. This approach is confidence based. It leverages 

on the evaluations conducted by selected competent drug 

regulatory agencies. Thus, allows flexibility in utilizing its 

expertise according to the depth of evaluation required yet 

ensuring robustness in the evaluation system.31 With years 

of effort in bringing international standards into the drug 

regulatory pro- cess, Singapore is accepted as a regulatory 

member, together with China, Taiwan (China), Republic of 

Korean and Brazil, of the Inter- national Council for 

Harmonization of Technical Requirements for 

Pharmaceuticals for Human Use (ICH). The ICH is a global 

platform for discussion of drug registration with regards 

its technicalitie



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and science. In Singapore, regulation of herbal medicines is 

subject to less stringent registration requirements than Western 

medicines.32 

 
Regulation of Chinese herbal medicines in Hong Kong 
(China) 

 
In Hong Kong (China), the term herbal medicines mean 

essen- tially herbal species that do not undergo any 

manufacturing to change their form. Proprietary Chinese 

medicines (pCm) are Chi- nese herbal medicines that have 

undergone some degree of manufacturing to be made into 

tablets, powder, liquid, etc. They are used to treat many 

medical problems, including gynecological and 

gastrointestinal disorders.33 The term pCm is clearly defined 

under the Chinese Medicines Ordinance.2 All pCm are 

categorized into established, non-established and new 

medicines.21 They must be registered with the statutory 

Pharmacy and Poisons Board before they can be legally 

marketed. Secondary review3 is conducted to ensure all pCm 

meet the registration requirements prescribed by the Board 

regarding their safety, efficacy and quality.35,37 Much efforts 

have been placed by the Hong Kong (China) government on 

improving the quality control and post marketing 

surveillance of pCm. Unlike registration of Western 

medicines which compliance 
with GMP standards is mandatory,38 manufactured licensed 
pCm, 

at present, is voluntary.39 A timetable will soon be set for the 

mandatory compliance of pCm manufacturing to the 

standards of GMP.40 To assist the accreditation process, 

regulatory services has been put in place to provide quality 

testing and assessment based on the Pharmacopeia of the 

People’s Republic of China and the Hong Kong Chinese Materia 

Medica Standards.41 For safety control, post registration 

monitoring of pCm in detecting any unfortunate adverse 

events has long been carried out in Hong Kong (China).41 

Since 2009, this surveillance program plays an important role 

in predicting and preventing the occurrence of adverse drug 

reactions especially when nonclinical safety data on drug 

interaction and pharmacogenomic studies are lacking or 

insufficient.37 
A strong regulatory infrastructure is essential in ensuring 
pCm 

products uphold high quality standards and safety, make true 

and non-misleading claims, and have appropriate and 

reasonable marketplace accessibility. The key regulatory 

barrier in Hong Kong (China) is the requirement for two CPPs 

as proof of quality and safety before a pCm can be registered 

for marketing. The intention of CPP is to provide quality 

assurance and to substitute the review of scientific and 

clinical dossiers to allow products to be registered in shorter 

timeframes. However, in Hong Kong (China), the 

requirement does not fully substitute an internal review of 

QSE. More test results and summary reports are required 

with further queries may be raised and together with the 

waiting time to obtain the CPP from the issuing countries, it 

defies the intention of requiring CPP submission in allowing 

patients to have earlier access to the medicines. For Hong 

Kong (China) to play a bridging role in 

 
2 The definition of pCm is defined under the Chinese Medicines 

Ordinance.34 pCm means any proprietary product e(a) composed solely 

of the following as active ingredients e(i) any Chinese herbal medicines; 

or(ii) any materials of herbal, animal or mineral origin customarily used by 

the Chinese; or(iii) any medicines and materials referred to in subparagraphs 

(i) and (ii) of paragraph 3 (a) respectively;(b) formulated in a finished dose 

form; and(c) known or claimed to be used for the diagnosis, treatment, 

prevention or alleviation of any disease or any symptom of a disease in human 

beings, or for the regulation of the functional states of the human body. 
3 Secondary review requires approval of drugs based on the reviews 

conducted by two reference ICH drug regulatory authorities. These countries 

are the US or Europe and Japan.35 The Certificate of Pharmaceutical Product 

from these countries are the evidence of approval. Most countries, including 

Hong Kong (China), require this certificate/document to proof that the 

medicinal products they imported meet a stipulated acceptable level of 

safety and health in their healthcare sector.36 

leading China’s internationalization of TCM, 

the registration pro- cess of pCm should 

consider becoming independent from the 

requirement of CPP for quality and safety 

assurance. 
Hong Kong (China), have long been recognized as a 

country having a reasonably established clinical practices 

and basic scien- tific research and development for TCM. 

With its current focus on improving quality control and 

enrichment in clinical expertise, the area that worth further 

strengthening will likely be the nonclinical assessment 

capacity when the feasibility of conducting review for a 

simplified registration for eligible pCm with long history of 

use is to be explored. 

The waiver of a thorough evaluation with a minimum 

nonclin- ical package in bibliographical applications for EU 

registration purpose represents a golden opportunity for 

Hong Kong (China) to take its first entry to evaluate pCm 

with long history of use not previously registered and 

marketed in other countries. Although the objective of 

having an EU simplified procedure aims to ensure a freedom 

of movement for herbal medicines within the EU, it does 

provide a framework of a minimum package to demonstrate 

‘acceptable safety’. It is important to note that although the 

EU simplified registration for traditional herbal medicinal 

products does include TCM, this particular registration 

process has set tight limitations. It is restricted to TCM that 

has been in the EU for at least 15 years with administration 

pathways restricted to oral, inhalation and external use.20 

Therefore, there are a great number of TCM that are 

prevented from attaining registration as traditional herbal 

medicinal products according to the outlines of the EU.22 In 

other words, the ‘minimal nonclinical package’ route of 

registration does not apply to most TCMs. Projecting the 

same principle to a Hong Kong (China) society, there are 

much wider range of TCM products satisfying minimal 

nonclinical package demonstrating ‘acceptably safe’ for 

pCm that have been in traditional medicinal use throughout 

a period of at least 30 years, including 15 years in China or 

Hong Kong (China). The establishment of a TCM registration 

process in Hong Kong (China) would pave the future for 

better recognition and growth of the TCM market beyond 

Hong Kong (China) and the region. 
One of the limitations in Hong Kong (China) drug 
regulation is 

the lack of number in expertise. The recognition of 

pharmacovigi- lance and long-standing use of pCm as 

evidence of an accepted safety profile to support a range of 

pharmacology and toxicology, including safety 

pharmacology, pharmacokinetics, single and repeat dose 

toxicity, toxicokinetics, immunotoxicity and local tolerance 

studies,23 reduce the nonclinical package significantly. This 



 

 

notably lessen the demand on nonclinical 

expertise/evaluators and allow a much-needed focus on 

capability building in address- ing the major concern in 

reducing kinetic and clinical interaction concern in 

reducing the number of adverse events due to use of pCm 

concomitantly with other medicines. 

To implement a primary (first-hand) yet simplified 

evaluation route based on international practice within 

drug registration process for pCm in Hong Kong (China), a 

progressive approach can be adopted. For example, a new 

independent center can be set up to complement the 

regulatory role of the existing drug regulatory agency 

before the evaluation capability is achieved. The indepen- 

dency and flexibility in funding and structural reform will 

allow the new set up to focus only on the scientific 

evaluation on pCm of long history of use, while building up 

its drug evaluation capabilities, particularly in 

pharmaceutical chemistry, pharmacology, toxicology and 

clinical disciplines. Recognizing its own limited resources in 

pharmaceutical sciences professionals, the use of both 

internal and external expertise is worth considering. Both 

local and overseas from local universities, hospitals and 

research institutes can be engaged as external evaluators to 

conduct drug evaluation and participate in capabilities 

building. It is worth noting that a 

sustainable development of such regulatory capacities will 

provide encouragement for growth in research and 

development within Hong Kong (China) by the pharmaceutical 

industries and in the future, establish Hong Kong (China) as the 

origin for new and innovative pCm. 

Having an option to approve pCm with long history of use 

based on international standard while maintaining the existing 

review process, incur minimum burden to the registration of 

both Chinese and Western medicines. This new evaluation 

route not only will allow both local and overseas pCm with long 

history of use to obtain marketing authorization in Hong Kong 

(China) within the timeframe like other regulatory agencies 

that conduct the simpli- fied evaluation. It will also allow the 

approved pCm to expand its market globally using the CPP 

issued by the Hong Kong (China) Government when the 

necessary conditions are met. With this, the pCm trade sector 

will be better positioned and able to provide users an earlier 

access to increased variety of quality and safer medicines. In the 

long term, the building of this infrastructure will encourage the 

modernization of pCm and the improvement in drug evaluation 

capabilities will become the platform for further grow in the 

drug regulatory system in Hong Kong (China). 
There are opportunities and challenges for Hong Kong (China) 
to 

conduct first-hand review on eligible traditional pCm with long 

history of use. With the simplified EU registration process and 

the finalised minimum nonclinical package for traditional 

herbal me- dicinal products, it is a good time to strengthen the 

drug registra- tion and regulatory infrastructure of Hong Kong 

(China). The internal and external factors to the growth, 

success and threats to globalising pCM with long history of use 

are listed in Table 1. 

Concluding remarks 

 
Most herbal products that are currently available in the 

global market have yet to be subjected to drug approval 

process to demonstrate their safety and effectiveness, the 

final release of the minimum package of nonclinical in 

bibliographical applications provides an avenue to further 

reduce cost and resources in con- ducting extensive animal 

studies to fulfilling the safety re- quirements for the EU 

regulatory authorities. With this mechanism, more well-

established and traditional herbal medicines could be 

encouraged to register and obtain marketing authorization 

in EU and worldwide. 

Hong Kong (China) has relatively stringent documentary 

re- quirements for marketing pCm among the Asian cities.3 

However, its secondary review process while assuring QSE 

meeting interna- tional standard, requires a substantial 

amount of time in registra- tion and marketing 

authorization of pCm. This has been a significant obstacle 

to the pharmaceutical traders and users in Hong Kong 

(China). 

For Hong Kong (China) to be promoted to be a TCM hub 

and fulfilling its major role in leading the 

internationalization of pCm, a concerted regulatory effort in 

building a sound registration process, a good network for 

conducting epidemiological/clinical studies as well as post-

marketing experience is essential. 

With the support from the government and the maturing 

GMP compliance framework for pCm, there is an 

opportunity for Hong Kong (China) to develop an additional 

registration process to approve pCm of long history of use 

based on the simplified pro- cedure established in the EU. 

Hong Kong (China) possesses the 
 
 

 
Table 1 

Opportunities and challenges for Hong Kong (China) to conduct first-hand 
review on pCm with long usage history based on the EU simplified registration 

process. 
 

Strength 

1. Clear direction from Government to support the growth of TCM 

2. Strong financial business infrastructure to support Hong Kong (China) as 
Chinese medicine registration hub 

3. Independent Chinese and Western medicine regulatory 

framework, and hence having more flexibility in making policy 

changes in adopting new evaluation and registration processes 

for Chinese medicine without the need to implicate Western 

medicine framework 

4. Large pool of Chinese medicines in traditional medical use of at least 30 
years, including 15 years in Hong Kong (China) 

5. Existing GMP accreditation process for manufacture of pCm, and post 
marketing surveillance program 

6. Good scientific and clinical expertise to enrol as internal or external 
evaluators 

7. Inherit good cultural and philosophical understanding of Chinese medicine 

8. Good regulatory network with Asiaepacific countries 

Weakness 

1. Hong Kong (China) has insufficient global impact in the area of drug 
registration 

2. Inexperience in conducting first-hand/full evaluation of pCm, particularly 
in the area of nonclinical assessment 

3. Relying on CPP from other countries for registration of Chinese medicine 

4. Limited financial commitment from licensed TCM manufacturers 

Opportunities 

1. EU’s acceptance of waiving the full ICH nonclinical evaluation with a 
minimum package to demonstrate safe use of traditional herbal products 

2. Adopt the EU simplified registration process with minimum nonclinical 
package to be an option to register eligible pCm with long usage history 

3. Less demand on regulatory/evaluation capacity/capability under the 
simplified registration process 

4. Be the first country to conduct full review and globalise eligible pCm 

as Hong Kong (China) registered traditional pCm based on the EU 

recognised simplified registration process 

5. To becoming a CPP independent country for traditional pCm with a 
recognised simplified registration process 

6. To promote the use of Hong Kong (China) issued CPP/marketing 

authorisation of eligible traditional pCm for their registration of use 

and marketing in Southeast and Asiaepacific countries 

7. To explore advantages and synergise the use of Chinese and Western 

medicine by analyzing differences in their origin for human health 

between Chinese and Western medicine 

8. Preserve therapeutic values of TCM 

Threats 

1. Change in EU position on the acceptance of simplified registration 

and the use of minimal nonclinical package as a demonstration of 



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safe use of traditional herbal medicines 

2. Other countries not receptive with EU position for minimum nonclinical 

package 

3. Other countries do not accept the waiver of full nonclinical package 

for registration of TCM in Chinese society. Demand for submission 

of additional ethnical/non- Chinese data to demonstrate safety and 

efficacy 

4. Immature drug regulatory framework to support pre- and post-marketing 
authorisation on safe use of medicines 

5. Non-acceptance by Western medical profession 

6. Diminishing global interest in TCM 

Abbreviations: pCm: proprietary Chinese medicines; EU: European Union; 

TCM: traditional Chinese medicine; GMP: Good Manufacturing Practices; CPP: 

Certificate of Pharmaceutical Product; ICH: International Council for 

Harmonization of Technical Requirements for Pharmaceuticals for Human Use. 
 

academic capabilities to strengthen its drug evaluation 

capabilities to accept QSE dossier submission. The use of 

both internal and external expertise is a good option to 

expand the pool of expertise available in specialized area. An 

integration of a new evaluation route into an existing CPP 

dependent registration process has been successfully 

implemented in other countries. The advancement of Hong 

Kong (China) to be a location that can provide QSE assurance 

for the eligible pCm without waiting for reassurance from 

other countries’ CPP will encourage local manufacturers to 

export and open their products to the global market. 

Understanding and translating Chinese medical texts is 

complex. An inherited knowl- edge of the philosophical and 

holistic approach of TCM could progressively result in a 

faster evaluation and approval timeframe than the Western 

countries in a worldwide simultaneous submis- sion. 

Supported by Hong Kong (China)’s internationally recognized 

business infrastructure, a constructive drug regulatory 

reform could lead Hong Kong (China) to provide patients’ 

earlier access to pCm, facilitate importation and exportation 

of pCm, and most importantly allows the therapeutic values 

of these herbal medicinal products to be preserved with 

health care professionals in a better position to make 

informed decisions about pCm usage alongside with Western 

medicines. 

 
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