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Special Provisions on the Administration of Registration of Traditional Chinese Medicines for Public Solicitation (Draft for Comments)

 Last Update: 2022-12-04
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In order to implement the "Opinions of the Central People's Republic of China/CPC Central Committee on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine", follow the development law of traditional Chinese medicine, and highlight the characteristics of traditional Chinese medicine, the State Food and Drug Administration organized the drafting of the "Special Provisions on the Registration and Administration of Traditional Chinese Medicines (Draft for Comments)", which was publicly solicited for comments
on April 29, 2020.
With the deepening of the reform of the review and approval mechanism of traditional Chinese medicines, the NMPA has further organized research, research, demonstration, comprehensive revision and improvement on the basis of the previous work, and is now open to the public again for comments
.

The public comment period is from November 11 to November 25, 2022
.
Relevant comments can be sent to zhongyaominzuyaochu@nmpa.
gov.
cn, please indicate "Feedback on Special Provisions on the Registration and Administration of Chinese Medicines"
in the subject of the email.

Annexes: 1.
Special Provisions on the Registration and Administration of Traditional Chinese Medicines (Draft for Comments)

2.
Draft instructions

3.
Feedback form

General Department of the State Food and Drug Administration

November 11, 2022

Annex 1

Special Provisions on the Registration and Administration of Chinese Medicines (Draft for Solicitation of Comments)

Chapter I General Provisions

Article 1 [Legislative Basis] These Regulations
are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on Traditional Chinese Medicine, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration and other laws and regulations, in order to promote the inheritance, innovation and development of traditional Chinese medicine, follow the laws of traditional Chinese medicine research, and strengthen the registration and management of traditional Chinese medicine.

Article 2 [Promoting the Inheritance and Innovation of Chinese Medicine] The development of Chinese medicine shall pay attention to embodying the original thinking and overall view of Chinese medicine, and encourage the use of modern science and technology and traditional Chinese medicine research methods to research and develop Chinese medicine
.
Support the development of new Chinese medicine drugs with rich clinical practice experience in Chinese medicine, such as traditional Chinese medicine preparations prepared by ancient classics, famous old Chinese medicine prescriptions, and medical institutions (hereinafter referred to as traditional Chinese medicine preparations in medical institutions); Support the development of new Chinese medicine drugs with multi-target systemic regulation and intervention functions for the human body, and encourage the use of scientific principles to explain the mechanism of action of
Chinese medicine.

Article 3 [Adhere to Clinical Value-oriented] The development of traditional Chinese medicines shall adhere to the orientation of clinical value, attach importance to the assessment of clinical value, give play to the unique advantages and roles of traditional Chinese medicine in disease prevention and treatment, and pay attention to meeting unmet clinical needs
.

Article 4 [Adhere to the Guidance of Chinese Medicine Theory] The development of traditional Chinese medicines shall be under the guidance of traditional Chinese medicine theory, and the expected functions, main symptoms, applicable populations, dosage, course of treatment, efficacy characteristics, and medication should be avoided
in the development of traditional Chinese medicines.
Encourage the observation of disease progression, symptom transformation, symptom changes, post-drug reactions and other laws in the clinical practice of Chinese medicine, and provide supporting evidence
of Chinese medicine theory for the development of new Chinese medicine drugs.

Article 5 [Emphasis on Clinical Practice] New Chinese medicine drugs derived from the clinical practice of traditional Chinese medicine shall, on the basis of summarizing individual drug experience, gradually clarify the functional indications, applicable populations, dosing regimens and clinical benefits through clinical practice, form fixed prescriptions, and on this basis, develop new traditional Chinese medicine drugs suitable for group use
.
Encourage high-quality human experience research in the clinical practice of Chinese medicine, clarify the clinical positioning and clinical value of Chinese medicine, continuously analyze and summarize based on scientific methods, and obtain sufficient evidence
to support registration.

Article 6 [Adopt a Scientific and Reasonable Review Evidence System] The registration and review of traditional Chinese medicines adopts a review evidence system combining traditional Chinese medicine theory, human use experience and clinical trials to comprehensively evaluate the clinical effectiveness and safety
of traditional Chinese medicines.

Article 7 [Improving the Evaluation of the Efficacy of Traditional Chinese Medicines] The evaluation of the efficacy of traditional Chinese medicines shall combine the characteristics of clinical treatment of traditional Chinese medicines to determine the efficacy outcome indicators
that are compatible with the clinical positioning of traditional Chinese medicines and reflect their characteristics and advantages.
The evaluation of the cured or delayed development of the disease, the improvement of the condition or symptoms, the improvement of the patient's disease-related body functions or quality of life, the combination with chemicals, etc.
, can be used to evaluate the efficacy of traditional Chinese medicine
.

Encourage the use of new tools and methods such as real-world research, patient-centered drug development, adaptive design, and enrichment design for the evaluation
of the efficacy of traditional Chinese medicines.

Article 8 [Requirements for Safety Evaluation in Compliance with the Characteristics of Traditional Chinese Medicines] The safety of traditional Chinese medicines shall be comprehensively evaluated based on the composition and characteristics of prescriptions, the theory of traditional Chinese medicine, human experience, clinical trials and necessary non-clinical safety research results, and strengthen the management
of the whole life cycle of traditional Chinese medicines.

Article 9 [Strengthen Quality Control in the Whole Process of the Development of Chinese Medicines] Registration applicants (hereinafter referred to as applicants) shall strengthen the quality control of the source of Chinese medicinal materials and pieces of Chinese medicinal herbs in the development of traditional Chinese medicines, carry out resource assessment of medicinal materials, ensure the traceability of the source of traditional Chinese medicinal materials, and clarify the origin, origin, harvest period, etc
.
of the medicinal materials.
Strengthen the quality control of the whole production process and keep the quality between batches stable and controllable
.
The taste of prescription Chinese medicine can be fed after quality uniformization
.

Article 10 [Ensuring the Sustainable Use of Chinese Medicine Resources] Applicants shall ensure the sustainable use of Chinese medicinal materials resources and shall pay attention to the impact on the
ecological environment.
Where endangered wild animals and plants are involved, relevant national provisions
shall be complied with.

Article 11: [Measures to Support the Acceleration of the Whole Process of Traditional Chinese Medicine Innovation] The national drug regulatory department comprehensively coordinates the development of drug review, registration and inspection, on-site verification, generic name approval, and other such work, and the national drug review, verification, and inspection institutions adopt measures such as linkage of research and review, and front-end services, to accelerate the development of
innovative traditional Chinese medicine drugs.

Article 12 [Support for Chinese Medicines to "Go Global"] The national drug regulatory department shall organize and carry out international exchanges on the registration and management of traditional Chinese medicines, strengthen cooperation with international organizations, and promote the "going global"
of traditional Chinese medicine products.

Chapter II: Registration Classification and Market Approval of Traditional Chinese Medicines

Article 13 [Clarify the Registration Classification of Chinese Medicines and Requirements for Application Materials] The registration classification of Chinese medicines includes innovative Chinese medicines, improved new drugs of traditional Chinese medicines, compound preparations of ancient classic famous Chinese medicines, and drugs with the same name
.
The refinement of the registration classification of Chinese medicines and the corresponding application materials requirements shall be implemented
in accordance with the Requirements for Registration Classification and Application Materials of Chinese Medicines.

Article 14 [Selection of Development Paths or Modes of New Chinese Medicines in Accordance with the Actual Development of Varieties in Combination with the Registration and Classification of Traditional Chinese Medicines] The research and development of new Chinese medicines shall be combined with the registration classification of traditional Chinese medicines, and the research and development path or mode
that meets the characteristics of the varieties shall be selected.
Chinese medicines that discover and explore the efficacy characteristics based on Chinese medicine theory and human experience, mainly confirm their efficacy through human experience and/or necessary clinical trials; To determine the Chinese medicines to be developed based on pharmacological screening studies, necessary clinical pharmacology studies shall be conducted, and exploratory clinical trials and confirmatory clinical trials
shall be carried out in an orderly manner.

Article 15 [Simplified Approval of Marketing Applications for Ancient Classic Prescription Preparations] Simplified registration approval shall be implemented for the marketing application of ancient classic Chinese medicine compound preparations (hereinafter referred to as ancient classic prescription preparations), and the specific requirements shall be implemented
in accordance with relevant provisions.

Article 16 [Implementation of a Priority Review System Based on Clinical Value] Priority review and approval shall be carried out for registration applications for traditional Chinese medicines and new drugs under the following circumstances where the clinical positioning is clear and have obvious clinical value:

(1) Used for the prevention and treatment of major diseases and rare diseases;

(2) Clinical urgent need and market shortage;

(3) Medication for children;

(4) The substance is basically clear, and the mechanism of action of the drug is basically clear
.

Article 17 [Conditional Examination and Approval of Traditional Chinese Medicines] For the treatment of diseases that seriously endanger life and for which there are no effective means of treatment, as well as traditional Chinese medicines that are urgently needed by the competent department of health or traditional Chinese medicine under the State Council, where there are data in clinical trials of drugs or empirical evidence of high-quality traditional Chinese medicines showing efficacy and predicting their clinical value, conditional approval may be attached, and relevant matters
shall be stated in the drug registration certificate.

Article 18 [Special Approval of Traditional Chinese Medicines Using Human Experience in Public Health Emergencies] In the event of a public health emergency, the competent department of health or traditional Chinese medicine under the State Council determines that traditional Chinese medicines are urgently needed, and evidence of human experience may be used to directly apply for clinical trials or marketing authorization or increase functional treatment
in accordance with special approval procedures.

Chapter III: Rational Application of Human Empirical Evidence

Article 19 [General Description of the Characteristics of Human Use Experience of Traditional Chinese Medicines] Human experience of traditional Chinese medicines is usually accumulated in clinical practice, with certain regularity, reproducibility and clinical value, including the understanding and summary
of the clinical positioning, applicable population, dosage, efficacy characteristics and clinical benefits of traditional Chinese medicine prescriptions or preparations accumulated in the process of clinical drug use.

Article 20: [Compliance Requirements for Human Use Experience] Applicants may collect and sort out human use experience through multiple channels, and shall be responsible for the authenticity and traceability of the data, and the standardized collection, collation, and assessment of human use experience shall meet relevant requirements
.
As the key evidence to support the registration application, the drug regulatory department shall organize and carry out corresponding drug registration verification
in accordance with relevant procedures.

Article 21 [Use of Human Experience in Traditional Chinese Medicine] Human experience in reasonably and fully analyzing data and giving correct interpretation of results may be used as evidence
to support the registration application.
Applicants can determine follow-up research strategies and provide corresponding application materials
according to the degree of support for drug safety and efficacy with empirical evidence.

Article 22: [Pharmaceutical Requirements for Human Use Experience Research] The prescription drug flavor (including primogen, medicinal parts, preparation, etc.
) and dosage of drugs used by human experience as key evidence to support registration applications shall be fixed
.
The key pharmaceutical information and quality of the declared preparation should be basically consistent with the drugs used in human experience, and if the preparation process, excipients, etc.
change, it should be evaluated, and the research evaluation data
that provides support for relevant changes should be provided.

Article 23 [Exemption from the Declaration Materials for Prescriptions Only from Economic Prescriptions and Prescriptions] Where prescriptions for innovative Chinese medicine drugs come from ancient classical formulas or traditional Chinese medicine clinical experience, such as prescription composition, clinical positioning, dosage, etc.
are basically consistent with previous clinical applications, traditional techniques are basically consistent with clinical use of drugs, and functional indications, applicable populations, dosing regimens, and clinical benefits can be preliminarily determined through human experience, non-clinical effectiveness research
is not required.

Article 24 [Exemption or exemption of non-clinical safety research] Traditional Chinese medicine compound preparations composed of traditional Chinese medicine pieces generally provide toxicity test data for single administration and toxicity test for repeated administration, and other toxicological test data
when necessary.

If the Chinese medicine pieces in the prescription composition of traditional Chinese medicine compound preparations all have national drug standards or have drug registration standards, the prescription does not contain toxic medicinal odor or does not contain traditional Chinese medicine pieces that have been proved toxic by modern toxicology and are easy to cause serious adverse reactions, and the toxicity test of single administration and repeated administration toxicity test of one animal do not find obvious toxicity, generally there is no need to provide the repeated administration toxicity test, safety pharmacology test, genotoxicity test, carcinogenicity test, reproductive toxicity test data of another animal
。

The toxic medicinal odor referred to in the preceding paragraph refers to traditional Chinese medicine pieces (concocted products containing toxicity)
made from toxic medicinal materials included in the Measures for the Administration of Toxic Drugs for Medical Use.

Article 25 [Exemption from Exploratory Clinical Trials] Where new traditional Chinese medicine drugs derived from clinical practice can provide research evidence in clinical positioning, applicable population screening, treatment course exploration, dose exploration, etc.
, exploratory clinical trials
may not be conducted.

Article 26 [Introduction of Real-World Evidence] Where there are already people who have experienced the clinical research and development of traditional Chinese medicines, on the basis of fixed prescriptions and production processes, there is applicable high-quality real-world data, and the real-world evidence formed through well-designed clinical research is scientifically sufficient, and after the applicant communicates and reaches an agreement with the national drug evaluation agency on the real-world research plan, he may apply for real-world evidence as one of
the bases to support the marketing of the product.

Article 27: [Medical establishments shall continue to carry out the collection, collation, and assessment of experience data on traditional Chinese medicine preparations in medical establishments] Medical establishments are responsible for the safety, effectiveness, and quality controllability of traditional Chinese medicine preparations in medical establishments, and shall continue to standardize the collection and collation of experience data of traditional Chinese medicine preparations in medical establishments, and submit an annual report
on the collection, collation, and evaluation of the experience of traditional Chinese medicine preparations in medical establishments to the local provincial drug regulatory department.

Article 28 [Exemption of Declaration Materials for New Traditional Chinese Medicine Drugs Derived from Preparations of Medical Institutions] Where new traditional Chinese medicine drugs derived from preparations by medical institutions, such as prescription composition, process route, clinical positioning, usage and dosage, etc.
, are basically consistent with previous clinical applications, and can be preliminarily determined through human experience, functional indications, applicable populations, dosing regimens, and clinical benefits, etc.
, do not need to carry out non-clinical effectiveness research
。 If the composition of the prescription, extraction process, dosage form, packaging of direct contact drugs, etc.
are consistent with the traditional Chinese medicine preparations of the medical institution, on the basis of providing the pharmaceutical research data of the traditional Chinese medicine preparations of the medical institution, research materials such as dosage form selection, process route screening, and research on packaging materials in direct contact with the drug may not be provided
.

Article 29 [Encouraging Communication and Exchanges] Applicants may, according to the specific variety situation, communicate with the national drug evaluation agency on traditional Chinese medicine theory, human use experience research plan and human use experience data at the key research and development stage
.

Chapter IV: Innovative Drugs

Article 30 [Carrying out Drug Clinical Trials] Innovative traditional Chinese medicine drugs shall have sufficient evidence of effectiveness and safety, and in principle, randomized controlled confirmatory clinical trials shall be carried out before marketing, and the sample size shall be reasonably estimated
based on human experience and/or exploratory clinical trial results.

Article 31: [Evaluation of Efficacy Based on Diagnosis and Treatment Plans] Encourage the exploration of clinical trials and efficacy evaluation
of innovative Chinese medicine drugs based on clinical staging and time-sensitive medication based on clinical practice of traditional Chinese medicine.

Article 32 [Reasonably Establish Controls for Drug Clinical Trials] Encourage clinical trials of innovative traditional Chinese medicine drugs to give priority to the use of placebo controls or placebo controls
loaded with basic treatment when ethical requirements are met.

Article 33 [Clarify the Requirements for the Composition of Chinese Medicine Compounds] Chinese medicine tablets, extracts, etc.
may be used as prescription components
of traditional Chinese medicine compound preparations.
If it contains Chinese medicine pieces or extracts that do not have national drug standards and do not have drug registration standards, their drug standards shall be attached to the preparation drug standards
.

Article 34 [Research on Extracts and Preparations] Traditional Chinese medicine extracts and their preparations shall have sufficient basis for establishing a topic, and carry out research
on effectiveness, safety, and quality controllability.
A reasonable preparation process
should be studied and determined.
The structure type of the large class of ingredients and the structure of the main components should be studied and clarified, and the quality of extracts and preparations should be fully characterized by establishing quality control items such as content determination of main ingredients and large categories of ingredients and fingerprints or feature maps, so as to ensure the uniform and stable
quality of different batches of extracts and preparations.

Article 35 [Comparative Study of Extracts and Preparations] For new applications for the registration of extracts and their preparations, if there are already single-flavor preparations or single-flavor extract preparations on the market and the functional indications (indications) are basically the same, non-clinical and clinical comparative studies shall be conducted with such preparations to explain their advantages and characteristics
.

Article 36 [Basic Principles for the Research and Development of New Medicinal Materials] An application for registration of new medicinal materials and their preparations shall provide research materials on the taste, attribution, efficacy, etc.
of the medicinal material, and the relevant research data shall provide supporting evidence
for the taste, attribution, efficacy, etc.
of the new medicinal material formulated.

Article 37 [Enriching the Main Treatment Situations of Traditional Chinese Medicine Compound Preparations] Traditional Chinese medicine compound preparations can be divided into different situations according to the different main treatments:

(1) Chinese medicine compound preparations for symptom syndrome refer to Chinese medicine compound preparations used to treat Chinese medicine syndrome under the guidance of Chinese medicine theory, including Chinese medicine compound preparations for the treatment of diseases or symptoms of Chinese medicine, and the functions and main treatments are expressed
in Chinese medicine professional terms.

(2) The main treatment is a combination of Chinese medicine compound preparations, the "disease" involved refers to the disease of modern medicine, and the "certificate" refers to the syndrome of Chinese medicine, and its function is expressed in Chinese medicine professional terms, and the main treatment is expressed
in the way of combining modern medical diseases and Chinese medicine syndrome.

(3) Traditional Chinese medicine compound preparations that are mainly treated by diseases belong to special drugs for diseases and are formulated under the guidance of Chinese medicine theory
.
The "disease" involved is a modern medical disease, and its function is expressed in Chinese medicine terminology, and the main treatment is expressed
as modern medical disease.

Article 38 [Completion of Pharmaceutical Research in Stages] Registration applicants for innovative Chinese medicine drugs may conduct phased research for the main purposes of different research
stages, such as applying for clinical trials, confirmatory clinical trials, and applying for marketing authorization, according to the characteristics of traditional Chinese medicines and the general rules of research and development of new drugs.
The research of the credit stage of traditional Chinese medicine should reflect the concept of quality from design, pay attention to the integrity and systematization of research, and refer to relevant technical guidelines
for details.

Article 39: [Scientific and Reasonable Selection of Dosage Forms and Routes of Administration] Innovative traditional Chinese medicine drugs shall reasonably select dosage forms and routes of
administration on the basis of comprehensive analysis of drug production processes, physical and chemical properties, traditional drug methods, biological characteristics, dosage form characteristics, clinical drug safety, and patients' medication compliance on the basis of comprehensive analysis of drug production process, physical and chemical properties, traditional drug use methods, biological characteristics, dosage form characteristics, clinical drug safety, and patients' medication compliance.
Those who can choose oral administration do not choose injection administration
.

Article 40: [Carrying out Necessary Non-clinical Safety Tests] The development of innovative traditional Chinese medicine drugs shall carry out corresponding non-clinical safety tests
based on safety information obtained based on drug characteristics, clinical applications, and so forth.
Non-clinical safety trials
can be carried out in stages according to different registration categories, risk assessment and development processes.

Article 41 [Requirements for Non-clinical Research and Clinical Trial Samples] Samples used in non-clinical safety tests shall use samples of pilot or above scale
.
When applying for clinical trials, information shall be provided to explain the preparation of
samples for non-clinical efficacy and safety tests.
Samples used in clinical trials should generally be samples on a production scale
.
When applying for marketing, information shall be provided on the preparation of samples used in clinical trials, including test samples and placebos
.

Article 42 [Circumstances in which clinical pharmacology research shall be clarified] Where prescriptions contain toxic medicinal odors, or contain traditional Chinese medicine tablets, extracts, etc.
that do not have national drug standards and do not have drug registration standards, or where non-clinical safety test results show obvious toxic reactions and indicate that the human body may have a greater safety risk, or where it is necessary to obtain human pharmacokinetic data to guide clinical use of drugs, necessary clinical pharmacology research
shall be carried out.

Chapter V: Improved New Drugs

Article 43 [Clarify the Basic Principles for the Research and Development of Improved New Drugs] Support drug marketing authorization holders in carrying out research
on improved new drugs.
The research and development of improved new drugs shall follow the principles of necessity, scientificity and rationality, and clarify the purpose of
improvement.
On the basis of the marketed drugs, based on the objective, scientific and comprehensive understanding of the improved drugs, research should be carried out on the defects of the improved traditional Chinese medicines or the newly discovered therapeutic characteristics and potential in the process of clinical application
.
When developing improved new drugs for children, it shall conform to the characteristics of children's growth and development and medication habits
.

Article 44 [Advantages and Characteristics of Clinical Application of Improved New Drugs Modified Dosage Forms and Routes of Administration] Modified new drugs that change the dosage form or route of administration of traditional Chinese medicines that have already been marketed shall have advantages and characteristics of clinical application, such as increasing effectiveness, improving safety, improving compliance, etc
.
, or promoting environmental protection and improving production safety levels on the premise that effectiveness and safety are not reduced.

Article 45:[Change of route of administration shall be reasonable and necessary] An application for registration to change the route of administration of a marketed drug shall explain the reasonableness and necessity of changing the route of administration, carry out corresponding non-clinical research, and carry out clinical trials around the purpose of improvement, proving the advantages and characteristics
of the clinical application of changing the route of administration.

If the functional indications of the new route of administration are consistent with the original route of administration, at least confirmatory clinical trials
should be conducted.
If the functional indications of the new route of administration are inconsistent with the original route of administration, clinical trials shall be conducted in accordance with the requirements
of innovative drugs.

Article 46 [Basic Requirements for Modifying Dosage Forms] An application for registration to change a dosage form of a marketed traditional Chinese medicine shall provide sufficient basis to explain its scientific reasonableness
in light of clinical treatment needs, physical and chemical properties and biological properties of the drug.
The applicant shall carry out corresponding pharmaceutical research according to the specific situation of the new dosage form, and carry out non-clinical efficacy, safety research and clinical trials
when necessary.

For children's medication, special groups (such as dysphagia, etc.
), and some marketed traditional Chinese medicines that are inconvenient to use due to special usage, improve the clinical use compliance of drugs by changing the dosage form, and if the comparative study shows that there is no obvious change in the basis of medicinal substances and drug absorption and utilization after the dosage form is modified, and the clinical value of the original dosage form is fully based, there is no need to carry out clinical trials
.
For details, please refer to the relevant technical guidelines
.

Article 47 [Support for the Addition of Functional Treatments of Marketed Traditional Chinese Medicines] Except for the circumstances provided for in Articles 25 and 48, non-clinical effectiveness research materials shall be provided, and exploratory clinical trials and confirmatory clinical trials
shall be carried out in an orderly manner.

Those who extend the medication cycle or increase the dose shall provide non-clinical safety research data
.
If relevant non-clinical safety studies have been conducted before marketing and can support their extended cycle or increased dose, new non-clinical safety trials
may not be conducted.

If the applicant does not hold an application for adding functional indications to an already marketed Chinese medicine, he shall submit an application for registration of the same name and prescription drug at the same time, or the holder of the drug marketing authorization shall submit an application
.

Article 48 [Registration Application Materials for Exemption Applications for Increasing Functional Indications] Where an application for an additional functional treatment of a marketed traditional Chinese medicine uses empirical evidence to support the corresponding clinical positioning, non-clinical efficacy test data
may not be provided.
If the dose and course of use are not increased, and the applicable population remains unchanged, there is no need to provide non-clinical safety test data and exploratory clinical trial data, and confirmatory clinical trials
need to be carried out.

Article 49 [Encourage the Use of New Technologies and New Processes to Improve Listed Traditional Chinese Medicines] The State Drug Administration Department encourages the use of new technologies and new processes suitable for product characteristics to improve marketed traditional Chinese medicines
.
Where changes in the production process or excipients of marketed traditional Chinese medicines cause obvious changes in the basis of medicinal substances or the absorption and utilization of drugs, relevant non-clinical efficacy and safety tests, exploratory clinical trials, and confirmatory clinical trials shall be carried out for the purpose of improving effectiveness or improving safety, and shall be declared
for registration according to the improved new drug.

Chapter VI Ancient Classic Prescriptions of Chinese Medicine Compound Preparations

Article 50 [Clarify the Overall Management Requirements for Ancient Classic Prescription Preparations] Prescriptions for ancient classic prescription preparations that do not contain contraindications to compatibility or drug odors marked as highly toxic, highly toxic and proven toxic by modern toxicology shall be prepared using traditional processes, using traditional routes of administration, and the main functional treatment shall be expressed
in traditional Chinese medicine terms.
The development of such traditional Chinese medicine compound preparations does not require clinical trials
.
The drug approval number is given in a special format
.

Article 51:[Clarify Requirements for the Evaluation and Management of Ancient Classic Prescription Preparations] Ancient Classic Prescription Chinese Medicine Compound Preparations adopt a review model
based on expert opinions.
The Expert Review Committee of Ancient Classic Chinese Medicine Compound Preparations, mainly masters of traditional Chinese medicine, academicians and national famous Chinese medicine practitioners, conducts a technical review of such preparations, and issues a technical review opinion
on whether to agree to the marketing.
Relevant provisions shall be formulated
separately.

Article 52:[Clarify the Basic Requirements for the Development of Traditional Chinese Medicine Compound Preparations Managed in accordance with the Catalogue of Ancient Classic Formulas] When applying for marketing of a compound preparation of traditional Chinese medicines managed in accordance with the Catalogue of Ancient Classic Formulas, the applicant shall carry out corresponding pharmaceutical research and non-clinical safety research
.
In principle, the composition of prescriptions, the basis of medicinal materials, medicinal parts, processing specifications, converted doses, usage and dosage, functional indications, etc.
shall be consistent
with the key information of ancient classics released by the state.

Article 53:[Clarify the Basic Requirements for the Development of Other Traditional Chinese Medicine Compound Preparations Derived from Ancient Classic Formulas] In addition to providing corresponding pharmaceutical research and non-clinical safety test materials, the registration application for other traditional Chinese medicine compound preparations derived from ancient classic formulas shall also provide key information and basis for ancient classical formulas, and shall provide a systematic summary of the clinical practice of traditional Chinese medicine and explain its clinical value
.
The addition and subtraction of ancient classical formulas should be carried out
under the guidance of Chinese medicine theory.

Article 54:[Communication and Exchange of Ancient Classic Famous Chinese Medicine Compound Preparations] Based on the characteristics of ancient classic Chinese medicine compound preparations, applicants are encouraged to communicate with the national drug evaluation body on major issues such as benchmark sample research, non-clinical safety research, standardized collection and collation of human experience, and summary of clinical practice of traditional Chinese medicine at the key stage of research and development
.

Article 55:[Clarify Post-marketing Research Requirements for Ancient Classic Prescription Preparations] After the ancient classic prescription preparations are marketed, the drug marketing authorization holder shall carry out post-marketing clinical research on the drug, and continuously enrich and improve clinical evidence-based evidence
.
Drug MAHs shall continue to collect adverse reaction information, promptly revise and improve instructions, and promptly carry out non-clinical safety research
on unexpected adverse reactions found during clinical use.

Chapter VII Same name and prescription medicine

Article 56:[Basic Principles for the Development of Drugs with the Same Name and Prescription Drugs] The development of drugs with the same name and prescription drugs shall avoid low-level duplication
.
The applicant shall evaluate
the clinical value of the marketed traditional Chinese medicine used for control and with the same name and prescription as the developed drug (hereinafter referred to as the control drug with the same name).
The safety, efficacy and quality controllability of the same name prescription drug applying for registration shall not be lower than that of the control drug with the same name
.

The development of drugs with the same name and prescription shall comply with the relevant requirements
of laws and regulations such as the Patent Law of the People's Republic of China and the Regulations on the Protection of Varieties of Traditional Chinese Medicines to protect intellectual property rights.

Article 57:[Comparative Research on Drugs with the Same Name and Prescription Drugs of the Same Name and Comparison] The development of drugs with the same name and prescription drugs shall be compared with the control drugs with the same name in the quality control of the whole process of traditional Chinese medicinal materials, Chinese medicine pieces, intermediates, preparations
, etc.
The applicant evaluates whether to carry out non-clinical safety research and clinical trials
based on the evidence of efficacy and safety of the drug of the same name and prescription, as well as the process and excipients of the drug of the same name and the drug of the same name.

Article 58:[There shall be sufficient evidence for the selection of drugs with the same name and prescription drugs] The applicant shall select the drug with the same name and prescription based on the results of clinical value assessment
.
The traditional Chinese medicines approved for marketing after clinical trials in accordance with the requirements of drug registration administration, the marketed traditional Chinese medicines included in the current version of the Pharmacopoeia of the People's Republic of China, and the marketed traditional Chinese medicines that have obtained the certificate of protected variety of traditional Chinese medicines shall generally be regarded as having sufficient evidence
of safety and effectiveness.

"Listed Chinese medicines that have obtained a certificate of protection of traditional Chinese medicines" as used in the preceding paragraph refers to the protected varieties of traditional Chinese medicines that have ended their protection period and other protected varieties of traditional Chinese medicines that comply with the relevant provisions of the protection system for varieties of traditional Chinese
medicines.

Article 59:[Clarify Requirements for Carrying out Clinical Trials of Drugs with the Same Name and Prescriptions] Where the application for registration of the same name and the same prescription drug with the same name need to be compared through clinical trials, at least confirmatory clinical trials
must be conducted.
The extracted single-ingredient Chinese medicine can prove its consistency
with the control drug with the same name and prescription drug by bioequivalence test.

Article 60:[Declaration of Varieties with Standards and No Document Number] Varieties with national drug standards but no drug approval number shall submit an application
for registration in accordance with the same name and prescription drug.
The applicant shall carry out necessary clinical trials
based on the theory of medicine and human experience.

Article 61 [Clarify the Conditions for Exemption from Clinical Trials of Drugs with the Same Name and Prescriptions] Where there is sufficient evidence of efficacy and safety against the same name and prescription drug, and the process and excipients of the same name and prescription drug are the same as those of the same name and prescription drug, or the process and excipients of the same name and prescription drug do not cause obvious changes in the basis of medicinal substances or the absorption and utilization of drugs after research and evaluation, there is generally no need to carry out non-clinical safety research and clinical trials
.

Chapter VIII Post-Listing Changes

Article 62 [Clarify the General Requirements for Changes in Listed Chinese Medicines] Changes to marketed traditional Chinese medicines shall follow the characteristics and laws of traditional Chinese medicines themselves, and meet the relevant requirements
of necessity, scientificity and rationality.
Drug MAHs shall perform the main responsibility for change research, its assessment, and change management, and comprehensively assess and verify the impact of
changes on drug safety, efficacy and quality controllability.
According to the results of research, evaluation and relevant verification, determine the change management category of marketed traditional Chinese medicines, and the implementation of the change shall be carried out or reported
after approval and filing in accordance with the regulations.
Drug MAHs may communicate with the corresponding drug regulatory authorities in a timely manner during the post-marketing change study
.

Article 63:[Clarify Requirements for Changing Specifications] Changes to drug specifications shall follow the principle corresponding to the taste of prescription drugs and the principle
of coordination with applicable populations, usage and dosage, and filling specifications.

For those where the same variety is already on the market, the specifications applied for shall generally be consistent
with the listing specifications of the same variety.

Article 64:[Clarify the Requirements and Circumstances for Changing Production Processes and Excipients] Changes in production processes and excipients shall not cause obvious changes
in the absorption and utilization of medicinal substances or drugs.
The selection of production equipment should meet the requirements of
production process and quality assurance.

Article 65:[Clarify Requirements for Changing Usage and Dosage or Increasing the Scope of Applicable Populations] Where the dosage is changed or the scope of applicable populations is increased but the route of administration is not changed, non-clinical safety research materials that support the change shall be conducted, and clinical trials
shall be conducted when necessary.
Except in the circumstances provided for in Article 66, where it is necessary to carry out clinical trials to change the dosage or increase the scope of applicable populations, exploratory clinical trials and confirmatory clinical trials
shall be carried out in an orderly manner.

Where the dosage in the listed children's medication [Dosage] is unclear, necessary clinical trials can be carried out according to the characteristics of children's medication and human experience, and the dosage and course
of medication for children of different ages can be clarified.

Article 66 [Declaration Materials for Exemption from Application for Change of Usage and Dosage or Increase of the Scope of Applicable Populations] Where an application for changing the dosage of a marketed traditional Chinese medicine or increasing the scope of the applicable population, the functional treatment remains unchanged and the route of administration is not changed, and the empirical evidence supports the new usage and dosage after the change or the usage and dosage of the new applicable population, there is no need to conduct exploratory clinical trials, only confirmatory clinical trials
.

Article 67:[Clarify Requirements for Substituting or Subtracting Toxic Medicinal Odors or Medicinal Odors in Endangered Status] Replacing or subtracting toxic medicinal odors or medicinal odors in endangered states in national standard prescriptions shall be based on the composition and efficacy of prescription Chinese medicinal flavors, and comparative research
on pharmaceutical, non-clinical efficacy and/or non-clinical safety with the original drugs shall be carried out in accordance with relevant technical requirements.
If the toxic drug odor has been specified in the prescription is substituted or subtracted, confirmatory clinical trials
can be carried out with placebo.
Replace or subtract endangered drug odors from prescriptions, at least comparative studies
of confirmatory clinical trials.
If necessary, the generic name
of the drug needs to be changed at the same time.

Article 68 [Clarify the Change Requirements for Changing the Prescription of Traditional Chinese Medicine Compound Preparations Approved for New Drugs to Self-extraction] Where the extract approved for new drugs in the prescription of Chinese medicine compound preparations is changed from outsourcing to self-extraction, the applicant shall provide corresponding research materials, including but not limited to pharmaceutical research data of the extract and the Chinese medicine compound preparation obtained through self-research, comparative research data on the non-clinical efficacy and safety of the extract, and comparative research data of confirmatory clinical trials of the Chinese medicine compound preparation
。 The quality standard of the extract should be attached to
the preparation standard.

Article 69:[Requirements for Narrowing or Deleting the Scope of Principal Treatment or Applicable Population] Where the scope of the primary or applicable population is limited or deleted, the reasonableness of limiting or deleting the scope of the primary or applicable population shall be explained, and clinical trials
are generally not required.

Chapter IX: Drug Registration Standards

Article 70 [Clarify the Research and Formulation of Standards for Traditional Chinese Medicines] The research and formulation of registration standards for traditional Chinese medicines shall aim at achieving stable and controllable quality of traditional Chinese medicines, and establish control indicators
reflecting the overall quality of traditional Chinese medicines according to product characteristics.
Reflect the quality status of the product as much as possible, and pay attention to the correlation
with the effectiveness and safety of traditional Chinese medicine.

Article 71:[Explore the Establishment of Overall Quality Control Methods] Support the use of new technologies and methods to explore the establishment of intermediates for traditional Chinese medicine compound new drugs, fingerprints or feature maps for quality control of preparations, biological effect testing, and so forth
.
Testing items such as content determination in drug standards shall have a reasonable range
.

Article 72 [Clarify the relationship between enterprise internal control standards and drug registration standards] Based on product characteristics and actual conditions, the marketing authorization holder shall formulate enterprise internal control standards not lower than the drug registration standards, and improve the quality of
traditional Chinese medicine preparations by continuously revising and improving its inspection items, methods, limits, etc.

Article 73:[Continuous Improvement of the Quality Standard System for Traditional Chinese Medicines] After drugs are put on the market, production data shall be accumulated, and in combination with the development of science and technology, a complete quality standard system including Chinese medicinal materials, Chinese medicine pieces, intermediates and preparations shall be continuously revised and improved, so as to ensure that the quality of traditional Chinese medicine preparations is stable and controllable
.

Chapter X: Drug Names and Instructions

Article 74 [Clarify Requirements for Naming Generic Names of Chinese Medicines] The naming of proprietary Chinese medicines shall comply with the requirements of the "Technical Guidelines for the Naming of Generic Names of Proprietary Chinese Medicines" and relevant national provisions
.

Article 75:[Clearly require the instruction manual to indicate the toxic Chinese medicine pieces contained in the prescription] In the following circumstances, the name of the toxic Chinese medicine pieces contained in the prescription shall be indicated under the instructions [Ingredients], and the preparation shall be indicated in the warning language that the preparation contains the pieces:

(1) Chinese medicine tablets (containing toxic concoction products) made from toxic medicinal materials included in the Measures for the Administration of Toxic Drugs for Medical Use.

(2) Other Chinese medicine pieces
that the State Drug Administration deems necessary for warning.

Article 76 [Clarify the Relevant Requirements for Instructions for Labeling New Chinese Medicines for Differential Use] [Precautions] Instructions for Instructions for New Chinese Medicines Involving Differentiated Use shall include, but are not limited to, the following:

(1) Those who need to be cautious due to factors such as the evidence, pathogenesis, and constitution of traditional Chinese medicine, as well as precautions
related to drugs such as diet and compatibility.

(2) If there is post-drug care, it shall be clarified
.

Article 77:[Clarify the Requirements for Improving the Instructions for Listed Chinese Medicines] The holder of a marketing authorization for traditional Chinese medicine drugs shall strengthen the management of the whole life cycle of the drug, strengthen the monitoring, evaluation and analysis of safety risks, and shall promptly improve
the instructions [contraindications], [adverse reactions] and [precautions] with reference to relevant technical guidelines.

If any of the items in the [Contraindications], [Adverse Reactions] and [Precautions] of Chinese medicines are still "unclear" at the time of applying for drug re-registration, re-registration
will not be granted.

Article 78:[Requirements for Writing Instructions for Chinese Medicines that Meet the Characteristics of Chinese Medicines] The instructions for compound preparations of ancient classic Chinese medicines shall list [source of prescription], [theoretical basis for functional treatment] and other items
.

For new Chinese medicine drugs whose human experience is used as evidence for approval for marketing or to increase functional treatment, the item
[Clinical Practice of Traditional Chinese Medicine] shall be included in the label.

Chapter 11 Miscellaneous

Article 79:[Clarify Requirements for the Development of Natural Medicines] The pharmaceutical quality control of natural medicines may be implemented
with reference to these Provisions.
In the stage of confirmation of therapeutic effect, natural medicine innovative drugs should use data from at least one confirmatory test to show their effectiveness
.
The rest should meet the requirements of
modern medicine.

Article 80 [Clarify Requirements for the Registration and Administration of Overseas Marketed Traditional Chinese Medicines and Natural Medicines] Registration and administration related to the import of overseas marketed products shall meet the following requirements:

(1) The traditional Chinese medicines and natural medicines applied for import shall meet the requirements of the country or region where they are located in accordance with drug administration, and shall also meet the requirements
for the safety, efficacy and quality controllability of traditional Chinese medicines and natural medicines in China.
Where an application is made for import and marketing, clinical trials shall be carried out after approval in China, including necessary clinical pharmacology research, as well as exploratory clinical trials and confirmatory clinical trials
carried out in a sequential manner.
The registration application materials shall be provided in accordance with the requirements
of innovative drugs.
Where the State has other provisions, those provisions
shall prevail.

(2) If major changes such as changes in approval documents, indications/functional indications and indications occur in the country or region of origin, and major safety risk events occur in any country or region where imported traditional Chinese medicines, natural medicines or similar varieties are sold in any country or region around the world, they shall immediately report to the national drug evaluation agency according to the supplementary application, and the national drug evaluation agency shall take necessary regulatory measures
after assessment.

(3) If the drug is withdrawn from the market in the country or region of origin due to reasons such as safety and effectiveness, the import shall be stopped immediately and the national drug administration department shall initiate the withdrawal procedure
.

Article 81:[Clarify Requirements for the Development of Traditional Chinese Medicine and Natural Medicine Injections] The development of traditional Chinese medicines and natural medicine injections shall meet the general technical requirements
for injection research.
The necessity and rationality
of route of administration selection should be justified through adequate nonclinical studies based on the accessibility of available treatments.
The active ingredients and mechanism of action of drugs should be clear, and comprehensive non-clinical efficacy and safety studies should be carried out, and clinical pharmacology studies, exploratory clinical trials and confirmatory clinical trials
should be carried out in a sequential manner.

After the marketing of traditional Chinese medicine and natural medicine injections, the holder of the drug marketing authorization shall carry out post-marketing clinical research of the drug, continuously enrich and improve the clinical effectiveness and safety evidence, shall continue to collect adverse reaction information, promptly revise and improve the instructions, and promptly carry out non-clinical safety research
on unexpected adverse reactions found during clinical use.
The MAH shall strengthen quality control
.

Article 82:[Clarify Requirements for the Filing and Administration of Traditional Chinese Medicine Extracts] Implement record-filing management of volatile oils, greases, extracts, flow extracts, dry extracts, extracted single ingredients, and other traditional Chinese medicine extracts that are specified in the national drug standards and drug registration standards for traditional Chinese medicines, and have separate national drug standards or drug registration standards, and are used for the production of traditional Chinese medicine preparations, and specifically in accordance with the requirements of the "Implementation Rules for the Filing and Administration of Traditional Chinese Medicine Extracts
".

Chinese medicine extracts subject to record-filing management do not include extracts with specific preparation methods or standards attached to national drug standards and drug registration standards, traditional Chinese medicine extracts such as single ingredients extracted according to the approval of new drugs, products traditionally used according to Chinese medicinal materials or Chinese herbal tablets such as ice chips, Qingdai and ejiao, and products managed according to chemical APIs such as berberine hydrochloride
.

Article 83:[Include the Examination and Approval and Filing of Traditional Chinese Medicine Preparations by Medical Establishments in the Annual Report on Drug Review] The provincial-level drug regulatory departments shall submit an annual report
on the approval and filing of traditional Chinese medicine preparations by medical establishments to the State Drug Administration Department.
The national drug administration department shall, on the basis of the annual report submitted by the provincial drug regulatory department, include the approval and filing of traditional Chinese medicine preparations of medical institutions in the annual report
of drug review.

Chapter XII Supplementary Provisions

Article 84:[Definition and Scope of Chinese Medicines] "Chinese medicines" as used in these Provisions refers to medicinal substances and preparations derived from natural plants, animals, minerals, etc.
used under the guidance of Chinese medicine theory, including Chinese medicinal materials, Chinese medicine tablets, as well as Chinese medicine prescription preparations, traditional Chinese medicine preparations prepared by medical institutions, etc
.

Article 85:[Definition and Scope of Natural Medicines] Natural medicines refer to natural medicinal substances and their preparations
used under the guidance of modern medical theories.
Its sources include plants, animals and minerals, excluding substances derived from genetically modified animals and plants, substances fermented by microorganisms or chemically modified
.

Article 86:[Chinese Materia Medica Materials and Chinese Medicine Pieces Implementing Examination and Approval Management] Provisions on the Registration and Administration of Chinese Materia Medica Materials and Chinese Medicine Pieces for Examination and Approval Management shall be formulated
separately.

Article 87:[Clarify Implementation Time] These Provisions shall take effect
on the date of promulgation.
The general requirements for drug registration and administration not covered by these Provisions shall be implemented
in accordance with the Measures for the Administration of Drug Registration.
The Supplementary Provisions on the Registration and Administration of Traditional Chinese Medicines (Guo Food and Drug Administration [2008] No.
3) issued by the former State Food and Drug Administration on January 7, 2008 were abolished
at the same time.

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