China - Obtain a Certificate of Traditional Chinese Medicine

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Procedure

• The application dossiers shall be coded in order of the aforementioned directory, the appropriate name and contents number shall be indicated at the middle and upper right of the cover, the format of the contents number is "dossier X", where X stands for contents number.
• The application dossiers shall be printed uniformly with A4 paper (with left margin not less than 28mm, and page number 20mm above the middle position of page footer), the contents shall be complete, clear, and shall not be altered.
• The information submitted should be complete and standardized, the data should be truthful and reliable; cited literature should indicate the author's name, book name, publication name, volume, issue, page, and date; unpublished literature should provide proof documents of the authors consent for use. Foreign materials shall be translated into Chinese.
• Supplementary test data should provide the original copy, the cover of which shall have the name of the validation project, the signature of the person in charge of test, test unit name and official seal, and indicate the researchers of various tests, the time frame, time and place for storage of original data, contact name, phone, etc.; copies of supplementary proof documents should be stamped with the official seal of the applicants.
• The dossiers shall be in triplicate, one for CFDA Administrative Service Center, two for corresponding provincial (autonomous regions and municipalities)FDA , each dossier shall be enclosed into a separate portfolio, the cover of which shall indicate: Application category, drug name, original/copy, applicant organization, contact person, telephone.
• "Application form for protected TCM species": enterprises applying for TCM protection can download the form from CFDA Government website (http://www.cfda.gov.cn).
• CFDA shall publicize the species approved for protection on its government website and the "China Pharmaceutical News ".

After the Application is made to the Administrative Service Center, and the application dossiers submitted in order specified, the work staff shall review the format. If the application items are not subject to administrative examination and approval according to law, the decision of non-acceptance shall be immediately made. If the application items are not within the purview of the executive authorities, the decision of non-acceptance shall be immediately made and the applicant shall be informed to apply to related administrative institutions; .If the application dossiers have errors that can be corrected on the spot, the applicant shall be allowed to correct on the sport; if the application dossiers are incomplete or do not meet the statutory form, the applicant should be informed in full to enrich or rectify the relevant contents on the spot or within five days. If they are not informed, the application dossiers shall be deemed accepted from date of receipt. If the application dossiers are within the scope of the administrative institutions, the application materials are complete and comply with the statutory form, or the applicant has submitted all application materials in accordance with the requirements of the administrative authorities for enrichment or correction, the application shall be accepted for administrative examination and approval.

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Required Documents

• Information No (1) "Application form for protected TCM species"
• Information No (2) Proof documents;
  • Proof documents (copies) for drug approval, enterprises with initial application for protection should provide their relevant supporting information for the original research enterprise.
  • "Drug Production License" and "Drug GMP Certificate "(photocopy).
  • Current national drug standards, real samples of packaging inserts and labels.
  • Statements of patents ownership and other relevant proof documents.
• Information No (3) Overview of the rationale and the reasons for protection;
• Information No (4) Relevant medical information;
  • approval for pre-marketing research.
  • approval for after-marketing research.
• Information No (5) Medical related data
  • approval for pre-marketing research.
  • approval for after-marketing research.
• Information No (6) Relevant Pharmacology and toxicology data:
  • approval for pre-marketing research.
  • approval for after-marketing research.
• Information No (7) Proposed improvement planning and implementation programs.

Office Locations & Contacts

China Food and Drug Administration
Address: 26 Xuanwumen Xidajie, Beijing, 100053, P.R. China
Fax: 86-010-68310909
Email: [email protected]

National Health and Family Planning Commission of P.R.China
Address: No 1 Xizhimen Outer South Road, Xicheng District, Beijing
Postal code: 100044
Telephone: 010-68792114
Email: [email protected]

Eligibility

Provide eligibility criteria's for going through this procedure.

Fees

• Review fee: RMB 15,000 Yuan for each species
• Annual charges for protected species: RMB 7500 Yuan for each species

Validity

The validity of CFDA-issued Class I "Certificate of Protected TCM Species" is ten, twenty and thirty years, for Class II certificates, the validity is seven years. Extended term of protection shall not exceed the term of protection in initial approval.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Administrative licensing decision shall be made within 140 days from the date of acceptance. (Note: CFDA shall make the decision within 20 days. If a decision cannot be made within 20 days, and extension of 10 days can be granted with competent leaders consent.) The above timeframe does not include the time for supplementary information and the corresponding review.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 
	

Instructions

A practitioner of traditional Chinese medicine cannot engage in traditional Chinese medicine service until he has passed the qualification examination in accordance with the laws, administrative regulations and department rules on health administration and obtained a license through registration.

A person who has studied traditional Chinese medicine in the way of apprenticeship or a person who has proved to have special expertise in this field cannot practice traditional Chinese medicine until he has passed the appraisal and examination for the qualification of a licensed doctor or licensed assistant doctor in accordance with the provisions of the health administrative department of the State Council and obtained a doctors license through registration.

Required Information

The contents in the form should be true, complete, clear, and shall not be altered. Enterprise name, drug name, approval number, dosage form, specifications and other items should be consistent with the valid approval certificates.

In the column of "production and quality management", aside from introductions of the production and quality management, the applicant must also specify the name, model and manufacturer names of major production equipment and testing instruments associated with the products under application.

Need for the Document

Traditional Chinese Medicine (TCM) has made great contribution to the health of Chinese people for thousands years, and it became an independent medical system in world medical field with its special clinical effect, rational theory system and rich practice experience.

In Chinese medical history TCM was born, spread and developed along with Chinese people against various diseases, TCM education has also been carried out from one generation to another for thousands years.

Information which might help

The administrative department of traditional Chinese medicine of the State Council is responsible for administration of traditional Chinese medicine nationwide. The relevant departments of the State Council shall be responsible for the work related to traditional Chinese medicine within their respective functions and duties.

The department responsible for administration of traditional Chinese medicine of the local peoples government at or above the county level is responsible for administration of traditional Chinese medicine in its administrative area. The relevant departments of the local peoples government at or above the county level are responsible for the work related to traditional Chinese medicine within their respective functions and duties.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Regulations of the Peoples Republic of China on Traditional Chinese Medicine

China Food and Drug Administration

State Organs

National Health and Family Planning Commission of the PRC

Review and (initial) issuance of Certificate for protected TCM species

Others

The State protects, supports and develops the traditional Chinese medicine undertaking, lays equal stress on traditional Chinese medicine and Western medicine, encourages these two schools o