Provisions for Import Crude Drugs (Trial)
Chapter I General Provisions
Article 1 The Provisions is formulated to strengthen the supervision of import crude drugs and ensure their quality in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as “Drug Administration Law”) and the Regulations for the Implementation of Drug Administration Law of the People's Republic of China (hereinafter referred to as “Regulations for the Implementation of Drug Administration Law”) and provisions of relevant laws and regulations.
Article 2 The Provisions is applicable to application and approval, record filing, port inspection and supervision of import crude drugs.
Application and Approval of Import Crude Drugs refers to the procedure in which the State Food and Drug Administration, in accordance with the application, legal procedures and requirements, conducts technical evaluation and administrative examine on the crude drugs that are produced outside the territory of the People’s Republic of China and intended to be marketed and used within the territory, and determines whether or not to allow their import.
An applicant for crude drug importation shall be a drug manufacturer or drug distributor who has obtained a Drug Manufacturing Certificate or a Drug Supply Certificate and is located within the territory of the People’s Republic of China.
Article 3 The State Food and Drug Administration shall be responsible for the examination and approval of importation of crude drugs and shall supervise the procedures of filing and port inspection.
The (food and) drug administrations of provinces, autonomous regions and municipalities directly under the Central Government shall supervise import crude drugs in accordance with law.
The (food and) drug administration of a place where a port permitted for importation of drugs or a frontier port permitted for importation of crude drugs is located (hereinafter referred to as “Port” or “Frontier Port” (Food and) Drug Administration), shall be responsible for putting import crude drugs on record, organizing port inspection, and exercising supervision and control.
The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for sample testing of crude drugs that are imported for the first time and verification of their quality specifications.
The drug testing institutions designated by the State Food and Drug Administration shall be responsible for port inspection of import crude drugs.
Article 4 Crude drugs must be imported from the ports where the entry of import drugs is allowed or the frontier ports where the entry of import crude drugs is allowed. At the frontier ports where the entry of import crude drugs is allowed, only the crude drugs produced in the countries and regions adjacent to such ports may be imported.
Chapter II Application and Approval
Section I General Rules
Article 5 The State Food and Drug Administration shall publicize the items required in an application dossier and sample texts of relevant application documents at the place where applications for importing crude drugs are accepted.
Article 6 When applying for importation of a crude drug, an applicant shall, as required, submit true, standard and complete data describing actual conditions and shall be accountable for the authenticity of the content of the application dossier.
Article 7 Where there is an error in the application dossier that can be corrected on the spot, on-the-spot correction shall be allowed.
Article 8 Where an application dossier is incomplete or not complied with laws, an one-off notification on the content to be supplemented or corrected shall be given to the applicant on the spot or within five working days by the State Food and Drug Administration ; where the notification to the applicant is not issued within the timeline, the application is deemed as accepted upon the date the dossier is received. Where an application is not accepted, the reasons shall be given in written form.
Article 9 In the examination process, where the State Food and Drug Administration finds that some materials are necessary to be supplemented, it shall make a request once and for all. The applicant shall, within four months after receiving a notice to supplement materials, submit required materials, and the examination timeline shall be extended by 20 days upon the original timeline; where the supplementary materials are not submitted within the specified timeline, the examination shall be terminated. Where the supplementary materials cannot be submitted within the specified timeline due to force majeure, the applicant shall make a written application, with reasons, to the State Food and Drug Administration. The State Food and Drug Administration shall give its opinions on how to handle the matter within 20 days.
Article 10 Where an application for importing a crude drug is examined in accordance with law and confirmed in conformity with the requirements, the State Food and Drug Administration shall approve it within the specified timeline and send to the applicant the approval documents for the importation of the crude drug within 10 days; where an application is found not in conformity with the requirements, the applicant shall be notified of the result with reasons in written form within the specified timeline, and its right to apply for a re-examination or administrative reconsideration or to bring an administrative lawsuit shall also be told.
Article 11 Where other party's vital interests are found directly involved in an application item during the examination on an application for importing a crude drug, the State Food and Drug Administration shall inform the interested party of the matter. The applicant and the interested party may submit written opinions to state their cases and defend themselves or request for a hearing in accordance with law.
Article 12 The State Food and Drug Administration shall publish the procedures of accepting and examining the applications for crude drug importation, as well as relevant information about approved import crude drugs on its official website.
Section II Application and Approval of Crude Drug Importation
Article 13 Applications for crude drug importation include first-entry application and non-first-entry application. A first-entry application consists of first-entry application for importing a crude drug with an official standard and one without an official standard.
Article 14 To apply for importing a crude drug, an applicant shall fill in an Application Form for Crude Drug Importation as required and submit relevant materials to the State Food and Drug Administration.
Article 15 The State Food and Drug Administration shall make a preliminary review to see if the dossier submitted is standard and complete, and issue a notice of acceptance or non-acceptance within five days after receiving the application dossier.
Article 16 After a first-entry application for an import crude drug is accepted, the applicant shall immediately submit testing samples and relevant materials to the National Institute for the Control of Pharmaceutical and Biological Products.
Article 17 After receiving samples and relevant materials, the National Institute for the Control of Pharmaceutical and Biological Products shall complete sample testing within 30 days in respect of a first-entry application for an import crude drug with an official standard, or shall complete verification of quality specifications and sample testing within 60 days in respect of a first-entry application for an import crude drug without an official standard. The test reports and verification opinions shall be submitted to the State Food and Drug Administration.
Article 18 The State Food and Drug Administration shall complete its technical review and administrative examination on a crude drug within 40 days after receiving the test report and verification opinions from the National Institute for the Control of Pharmaceutical and Biological Products. Where the requirements are met, an Import Crude Drug Approval shall be issued; where the requirements are not met, a Notice of Examination Conclusion shall be issued with reasons.
Article 19 The State Food and Drug Administration shall complete its technical review and administrative examination on a crude drug within 30 days after accepting a non-first-entry application for an import crude drug. Where the requirements are met, an Import Crude Drug Approval shall be issued; where the requirements are not met, a Notice of Examination Conclusion shall be issued with reasons.
Article 20 The State Food and Drug Administration may conduct an on-site inspection at the production site of an import crude drug when necessary.
Article 21 The Import Crude Drug Approval is classified into a single-import approval and a multi-import approval. The former is valid for one year and the latter is valid for two years.
The format of Import Crude Drug Approval No. shall be: Guo Yao Cai Jin Zi + Year（4 digits） + Sequence number (4 digits).
Article 22 The State Food and Drug Administration shall issue a single-import approval for an application of importing a crude drug of endangered species or importing a crude drug for the first time.
Article 23 Where the name of applicant or port of delivery in an Import Crude Drug Approval is to be changed, the applicant shall submit a supplementary application and relevant materials to the State Food and Drug Administration.
The applicant of supplementary application shall be the holder of the original Import Crude Drug Approval.
Article 24 The State Food and Drug Administration shall conduct a preliminary review to see if the dossier is standard and complete and issue a notice of acceptance or non-acceptance within five days after receiving the supplementary application.
Article 25 The State Food and Drug Administration shall complete the administrative examination within 20 days after accepting the supplementary application. Where the application complies with the requirements, an Approval for Supplementary Application of Import Crude Drug shall be issued; where the application does not comply with the requirements, a Notice of Examination Conclusion shall be issued with reasons.
Article 26 The valid term of the Approval for Supplementary Application of Import Crude Drug shall be the same as that of the original approval.
Article 27 Where there is any disagreement on a disapproval decision made by the State Food and Drug Administration, the applicant may apply for a re-examination in written form with reasons to the State Food and Drug Administration within 10 days upon receiving a disapproval notice.
The scope of re-examination shall be limited to the original application item and original application dossier.
Article 28 The State Food and Drug Administration shall re-examine according to the examination timeline for and requirements on the original application item and make a decision after receiving the re-examination application. Where a decision of disapproval is revoked, the State Food and Drug Administration shall issue a corresponding Import Crude Drug Approval or Approval for Supplementary Application of Import Crude Drug to the applicant; where the original decision is maintained, another application for re-examination shall not be accepted by the State Food and Drug Administration.
Article 29 Where a sample test or verification of quality specifications is required for a re-examination, the timeline for and requirements on the original sample test or verification of quality specifications shall be applied.
Chapter III Registration and Filing
Article 30 After obtaining an Import Crude Drug Approval, the applicant shall import the crude drug through the port of delivery indicated in the approval.
When organizing importation of a crude drug, the applicant shall file a record at the (food and) drug administration of the port or frontier port, fill in an Application Form for Inspection of Import Crude Drug and submit relevant materials.
Article 31 The (food and) drug administration at a port or frontier port shall conduct an examination to see if the materials for record are complete, standard and true, and make a decision on the same day. Where the requirements are met, a Drug Import Note shall be issued to the applicant and the single-import approval shall be withdrawn; and a Notice for Port Inspection of Import Crude Drug, accompanied by a copy of materials for record filing, shall be issued to the drug testing institution designated by the State Food and Drug Administration. Where the requirements are not met, a Notice of Disapproval on Record Filing of Import Crude Drug shall be issued with reasons.
Article 32 The applicant shall ship back the import crude drug that is not approved for record filing. Where the import crude drug cannot be shipped back, it shall be disposed of under supervision of the (food and) drug administration at the port or frontier port in accordance with relevant provisions.
Chapter IV Port Inspection and Supervision
Article 33 A drug testing institution designated by the State Food and Drug Administration shall take samples at the specified storage place within two days in accordance with the Rules for Sampling of Import Crude Drug after receiving a Notice for Port Inspection of Import Crude Drug. At the time of on-site sampling, the applicant shall present the original of the certificate of origin of the crude drug.
Article 34 The drug testing institution designated by the State Food and Drug Administration shall examine and verify if the crude drug actually arrived is consistent with the original of the certificate of origin of the crude drug, on the basis of the record filing materials provided by the (food and) drug administration at the port or frontier port. Where the requirements are met, sampling shall be conducted, meanwhile, a Sampling Record of Import Crude Drug shall be filled in and the word “Sampled” shall be marked on the Drug Import Note with the official seal of the sampling institute; where the requirements are not met, sampling shall not be conducted and a Notice of Sampling Rejection of Import Crude Drug shall be delivered to the (food and) drug administration at the port or frontier port within two days.
The (food and) drug administration at the port or frontier port shall take administrative enforcement measures to seal or seize all the drug imported , and shall make a decision on how to handle it within seven days after receiving the Notice of Sampling Rejection of Import Crude Drug.
Article 35 The drug testing institution designated by the State Food and Drug Administration shall complete the testing within 20 days after sampling, issue an Import Crude Drug Test Report, send it to the (food and) drug administration of the port or frontier port where the institution is located, and give a notice to the applicant; where the testing cannot be completed within the specified timeline, the institution shall report it to the (food and) drug administration of the port or frontier port and give a notice to the applicant.
Article 36 For an import crude drug found in non-compliance with specifications after testing, the (food and) drug administration of the port or frontier port shall take administrative enforcement measures to seal and seize all the crude drug imported immediately after receiving the test report, and shall make an administrative decision within seven days; for a re-testing application, an administrative decision shall be made within 15 days from the date of issuing retesting result. At the same time, the relevant information shall be reported to the local (food and) drug administration of the province, autonomous region or municipality directly under the Central Government. The applicant shall report all the details of the import crude drug in terms of distribution and usage in written form to the (food and) drug administration of the port or frontier port where it is located within two days after receiving the test report.
Article 37 Where there is a disagreement on the testing result, the applicant may apply for a re-testing in accordance with the provisions in Article 67 of the Drug Administration Law. The drug testing institution shall report timely to the (food and) drug administration of the port or frontier port after accepting the application for re-testing, make a retesting conclusion within 20 days after the acceptance, report the result to the (food and) drug administration of the port or frontier port and give a notice to the applicant.
Article 38 For an import crude drug that is in compliance with the specifications after retesting, the (food and) drug administration of the port or frontier port shall immediately lift the administrative enforcement measures of sealing and seizing the drug after receiving the retesting result, and report it to the local (food and) drug administration of the province, autonomous region or municipality directly under the Central Government.
Article 39 For an import crude drug that fails to apply for retesting within the specified timeline or fails to be in compliance with the specifications after retesting, the (food and) drug administration of the port or frontier port shall make an administrative decision and take corresponding measures in accordance with law; meanwhile it shall report to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it locates.
Article 40 A first-entry import crude drug , prior to its distribution and use, must be sampled and tested by a drug testing institution designated by the State Food and Drug Administration, and shall not be distributed and used until it is tested as qualified.
Article 41 Where an import crude drug that is found, after testing, not conformed with the specifications has been transported to an area beyond the jurisdiction of the (food and) drug administration of the province, autonomous region or municipality directly under the Central Government where the port or frontier port is located, the said (food and) drug administration shall timely report to the (food and) drug administration of the province, autonomous region or municipality directly under the Central Government, where the crude drug has been transported. Some corresponding measures shall be taken by the latter.
Article 42 The package of an import crude drug shall comply with its quality requirements and be convenient for storage, transport and import inspection. Each package shall be marked with the Chinese name of the crude drug, approval number, place of origin, number of shipping mark, name of applicant, name of exporter, port of delivery, weight, and date of processing and packaging.
Chapter V Legal Liabilities
Article 43 In any of the circumstances provided in Article 69 of the Administrative Permission Law, the State Food and Drug Administration may revoke the relevant approval document of an import crude drug upon the request of the interested party or in accordance with its authority.
Article 44 In the process of examination and approval, record filing, or port inspection, any of the following cases shall be handled in accordance with Articles 72, 73, 74 and 75 of the Administrative Permission Law:
(1) Where an application for importing a crude drug that meets regulatory requirements is not accepted;
(2) Where the items of application dossier submitted for importing a crude drug is not publicized at the acceptance place;
(3) Where the obligation to inform the applicant is not performed during acceptance and examination;
(4) Where the applicant is not given an one-off notification of all the contents required to be supplemented when the application dossier is incomplete and/or not in conformity to the defined format;
(5) Where the reasons for non-acceptance or disapproval are not explained in accordance with law;
(6) Where an approval decision is made on an application of importing a crude drug that is not in conformity to the Provisions, or is made beyond statutory functions and authority;
(7) Where a disapproval decision is made on an application of importing a crude drug that is in conformity to the Provisions or an approval decision is not made within the timeline specified by the Provisions;
(8) Where a fee is charged without permission or against statutory items and standards;
(9) Where asking for or receiving property or money from others or seeking other illicit gains.
Article 45 Where an applicant conceals relevant conditions or provides a false material or sample when applying for importing a crude drug, the State Food and Drug Administration shall refuse to accept such application or disapprove it, and shall give the applicant a warning and reject any application for importing a crude drug from such applicant within one year.
Article 46 Where an applicant has obtained an Import Crude Drug Approval by providing a false proof, document, sample or by other fraudulent means, the State Food and Drug Administration shall withdraw such an approval, reject any application for importing a crude drug by such applicant within five years and impose a fine of not less than RMB 10,000 Yuan but not more than RMB 30,000 Yuan.
Where an applicant has obtained an Import Crude Drug Approval through illegal means such as bribe, the State Food and Drug Administration shall withdraw the approval and reject any application for importing a crude drug by the applicant within three years.
Article 47 If any drug testing institution designated by the State Food and Drug Administration issues a false test report or receives a fee in violation of law while conducting port inspection, it shall be punished in accordance with Article 87 and Article 96 of the Drug Administration Law.

Chapter VI Supplementary Provisions
Article 48 The working timeline specified in the Provisions shall be calculated by working days, excluding official holidays.
The first-entry import crude drug refers to a crude drug imported from a certain overseas origin for the first time.
The crude drug with an official standard refers to a crude drug with a national drug standard or a standard of a province, autonomous region or municipality directly under the Central Government.
The crude drug without an official standard refers to a crude drug without a national drug standard or a crude drug standard of a province, autonomous region or municipality directly under the Central Government but included in the approved formulary of Chinese traditional medicine preparations.
Article 49 The Provisions shall come into force as of February 1, 2006.
Any of provisions in respect of import crude drugs, issued prior to the enforcement of the Provisions, not in compliance with the Provisions shall be invalid as of the date when the Provisions enter into force.

Appendix 1
Application Dossier Items and Requirements for Importation of Crude Drug
I. Items and Requirements of Application Dossier for Non-first-entry Import Crude Drug
The applicant shall submit following materials, one copy each:
1. Application Form for Crude Drug Importation
2. Drug Supply Certificate or Drug Manufacturing Certificate and Business License of the applicant (photocopy)
3. Legal registration document of the supplier (e.g. Business License) (photocopy)
4. Purchase contract(photocopy)
5. Quality specifications and source of the crude drug
II. Items and Requirements of Application Dossier for First-entry Import Crude Drug
The applicant is required to submit following materials in duplicate respectively to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.
1. Application Form for Crude Drug Importation
2. Drug Supply Certificate or Drug Manufacturing Certificate and Business License of the applicant (photocopy)
3. Legal registration document of the supplier (e.g. Business License) (photocopy).
4. Purchase contract (photocopy)
5. Quality specifications and source of the crude drug
6. Documents proving the species of the crude drug (The documents shall be provided by an institution with a qualification of identifying animal or plant species within the territory of the People’s Republic of China.
Where the quality specifications of the import crude drug is provided by a province, autonomous region or municipality directly under the Central Government, in addition to above-mentioned materials, the applicant shall improve the specifications according to specific situation, and submit relevant research materials; where there is no official standard for the import crude drug, in addition to above-mentioned materials, the applicant shall submit following materials:
6.1. Description on medicinal materials in terms of its ecological environment, growth characteristics, morphological description, technology of cultivation or plantation (breeding) and processing at the place of origin, etc..
6.2. Drafting description of the quality specifications of the crude drug.
6.3. Summary of pharmacology and toxicology study.
6.4. Data of primary pharmacodynamics test and literatures.
6.5. Data of test for general pharmacological study and literatures.
6.6 Data of acute toxicity tests and literatures.
6.7. Documents proving that a formulation of a traditional Chinese medicine preparation approved in China contains the crude drug.
III. Items and Requirements of Supplementary Application Dossier
A. Change of applicant’s name
The applicant shall submit following materials, one copy each:
1. Supplementary Application Form for Crude Drug Importation.
2. Original Import Crude Drug Approval.
3. Previous Drug Supply Certificate or Drug Manufacturing Certificate and Business License of the applicant (photocopies).
4. Current Drug Supply Certificate or Drug Manufacturing Certificate and Business License of the applicant (photocopies).
5. Approval documents for changing the name of enterprise in the Drug Supply Certificate or Drug Manufacturing Certificate and Business License of the applicant (photocopies).
B. Change of Port of Delivery
An applicant shall submit following materials, one copy each:
1. Supplementary Application Form for Crude Drug Importation.
2. The original of the Import Crude Drug Approval.
3. Purchase Contract (photocopy).
All copies mentioned above shall be affixed with the official seal of the applicant.

Appendix 2
Items and Requirements of Dossier for Record Filing
The applicant shall submit the following materials in duplicate:
1. A copy of Import Crude Drug Approval (and a copy of Approval for Supplementary Application of Import Crude Drug).
2. A copy of Drug Supply Certificate or Drug Manufacturing Certificate of the applicant.
3. A copy of certificate of origin.
4. A copy of purchase contract.
5. Copies of packing list, bill of lading and freight invoice.
6. For the import crude drug transitted through other countries or regions, all purchase contracts, packing lists, bills of lading and invoices from the place of origin to various transit places shall be submitted at the same time.
7. For a crude drug involving endangered species, a copy of certificate issued by the endangered species import and export administration departments of the importing and exporting country shall be provided.
All copies mentioned above shall be affixed with the official seal of the applicant.