Laws of the People's Republic of China

the State Food and Drug Administration

Order of the State Food and Drug Administration

No. 22

The Measures for the Administration of Imported Medicinal Materials (for Trial Implementation), which were adopted upon deliberation at the executive meeting of the State Food and Drug Administration on October 21, 2005, are hereby promulgated, and shall go into effect as of February 1, 2006.

Director of the State Food and Drug Administration Shao Mingli

November 24, 2005

Measures for the Administration of Imported Medicinal Materials (for Trial Implementation)

Chapter I General Provisions

Article 1

With a view to strengthening the supervision and administration of imported medicinal materials and guaranteeing the quality of imported medicinal materials, and in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law" and the "Implementation Regulation" respectively) as well as other relevant laws and regulations, the present Measures are formulated.

Article 2

The present Measures shall apply to the application for, the examination and approval of, and the registration, record keeping, port inspection, supervision and administration of imported medicinal materials.

The expression "application for, examination and approval of imported medicinal materials" shall mean that the State Food and Drug Administration, upon an applicant's application and pursuant to the legal procedures and requirements, conducts technical review and administrative examination of the medicinal materials which are manufactured outside China but are intended to be sold or used inside China, and makes a decision on whether or not to approve the import.

An applicant for imported medicinal materials shall be a pharmaceutical production enterprise or commercial enterprise that has obtained the Pharmaceutical Production License or the Drug Business License in China.

Article 3

The State Food and Drug Administration shall be responsible for the examination and approval of the import of medicinal materials, and shall supervise and administer the registration and record keeping, and port inspection, etc.

The drug (food) administration of each province, autonomous region, or municipality directly under the Central Government shall supervise and administer imported medicinal materials according to law.

The drug (food) administration at the locality of a port permitting the import of drugs or a border port permitting the import of medicinal materials (hereinafter referred to as the port or border port drug (food) administrationshalladministration shall responsible for the registration and record keeping of imported medicinal materials, and shall organize port inspections to conduct supervision and administration.

The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the sample inspection, review of quality standards, etc. of the initially imported medicinal materials.

The drug inspection institutions as determined by the State Food and Drug Administration shall be responsible for the port inspection of imported medicinal materials.

Article 4

Medicinal materials must be imported via the ports permitting the import of drugs or the border ports permitting the import of medicinal materials as approved by the State Council. A border port permitting the import of medicinal materials may only import medicinal materials produced in the neighboring countries or regions.

Chapter II Application, Examination and Approval

Section 1 General Rules

Article 5

The State Food and Drug Administration shall make public the items of the application documents and the sample texts of the relevant application letter in the places of accepting the applications for the import of medicinal materials.

Article 6

An applicant shall provide true and complete documents as required and report the true facts when applying for the import of medicinal materials, and shall be responsible for the authenticity of the essential contents in the application documents.

Article 7

Where the application documents submitted by an applicant contain any error that may be corrected on the spot, the applicant shall be allowed to correct it on the spot.

Article 8

Where the documents submitted by an applicant are incomplete or do not satisfy the prescribed form, the State Food and Drug Administration shall, either on the spot or within 5 days, inform the applicant once for all of the contents to be supplemented. If it fails to inform the applicant within the prescribed time limit, the application shall be deemed as being accepted on the date of receipt of the application documents. If it refuses to accept the application, it shall explain the reasons in writing.

Article 9

Where the State Food and Drug Administration considers in the process of examination that further documents shall be supplemented, it shall so require once for all.

An applicant shall submit the supplementary documents as required within 4 months as of the date of receipt of the notification for supplementing documents, and the time limit of examination shall be extended for another 20 days on the basis of the original time limit. If it fails to submit the supplementary documents within the prescribed time limit, the application shall be rejected. If it is unable to submit the supplementary documents within the prescribed time limit due to force majeure, it must file a written application with the State Food and Drug Administration, and explain the reasons therefor.

The State Food and Drug Administration shall render its settlement opinions within 20 days.

Article 10

Where an application for the import of medicinal materials is found to be qualified upon examination, the State Food and Drug Administration shall make a decision of approval within the prescribed time limit, and serve to the applicant a proof document on approval of the import of medicinal materials within 10 days. If the application is found to be unqualified upon examination, the State Food and Drug Administration shall inform the applicant in writing within the prescribed time limit, give the reasons therefor, and inform the applicant of the right to apply for review or administrative reconsideration, or to lodge an administrative lawsuit.

Article 11

Where, in the process of examining an application for import of medicinal materials, the State Food and Drug Administration finds that the matter in question has a direct bearing on the major interests of others, it shall notify the interested party. The applicant and the interested party may submit written opinions to describe the facts and defend itself, or to legally request a hearing.

Article 12

The State Food and Drug Administration shall announce on its governmental website the process of accepting and examining applications for import of medicinal materials, as well as the relevant information on the medicinal materials to be imported upon approval.

Section 2 Application for, Examination and Approval of the Import of Medicinal Materials

Article 13

Applications for the import of medicinal materials include the applications for the initial import of medicinal materials and applications for the non-initial import of medicinal materials. The applications for the initial import of medicinal materials include applications for the initial import of medicinal materials with legal standards and applications for the initial import of medicinal materials without legal standards.

Article 14

To apply for the initial import of medicinal materials, an applicant shall fill in an Application Form for Import of Medicinal Materials pursuant to the provisions, and submit the relevant documents to the State Food and Drug Administration.

Article 15

The State Food and Drug Administration shall, within 5 days as of the date of receipt of the application documents, make formal examination of the conformity and completeness of the application documents, and send a notification on the acceptance or refusal of the application.

Article 16

After an application for initial import of medicinal materials is accepted, the applicant shall submit to the National Institute for the Control of Pharmaceutical and Biological Products the inspection samples and relevant documents in a timely manner.

Article 17

The National Institute for the Control of Pharmaceutical and Biological Products shall, after receipt of the inspection samples and relevant documents, finish the sample inspection within 30 days in the case of an application for the initial import of medicinal materials with legal standards, or finish the re-check of quality standards and sample inspection within 60 days in the case of an application for the initial import of medicinal materials without legal standards, and shall submit to the State Food and Drug Administration the inspection report and re-check opinions.

Article 18

The State Food and Drug Administration shall finish the technical review and administrative examination within 40 days as of the date of receipt of the inspection report and re-check opinions of the National Institute for the Control of Pharmaceutical and Biological Products. If the application is qualified, it shall issue an Approval Document for Import of Medicinal Materials; if the application is unqualified, it shall issue a Notification Document on Examination Opinions and explain the reasons therefor.

Article 19

The State Food and Drug Administration shall finish the technical review and administrative examination within 30 days as of the date of acceptance of an application for the non-initial import of medicinal materials. If the application is qualified, it shall issue an Approval Document for Import of Medicinal Materials; if the application is unqualified, it shall issue a Notification Document on Examination Opinions and explain the reasons therefor.

Article 20

The State Food and Drug Administration may, where necessary, inspect the production site of certain imported medicinal materials.

Article 21

The Approval Documents for Import of Medicinal Materials are classified into one-off approval documents and reusable approval documents. The one-off approval document shall be valid for 1 year, while the reusable approval document shall be valid for 2 years.

The format of the serial number of an Approval Document for Import of Medicinal Materials shall be: No. ___ of Gu¨® (which means nation) Y¨¤o C¨¢i (which means medicinal materials) J¨¬n (which means import) + 4-digit number of the year + 4-digit sequential number.

Article 22

The State Food and Drug Administration shall issue the one-off approval document to a qualified applicant for the import of endangered species of medicinal materials or for the initial import of medicinal materials.

Article 23

To modify the name of applicant or the port of arrival in an "Approval Document for Import of Medicinal Materials", the applicant shall file a supplementary application with the State Food and Drug Administration, and submit the relevant documents.

The applicant of a supplementary application shall be the holder of the original Approval Document for Import of Medicinal Materials.

Article 24

The State Food and Drug Administration shall, within 5 days as of the date of receipt of the supplementary application, make formal examination of the conformity and completeness of the application documents, and send out a notification on the acceptance or refusal of the application.

Article 25

The State Food and Drug Administration shall finish the administrative examination within 20 days as of the date of acceptance of a supplementary application. If the application is qualified, it shall issue an Approval Document for the Supplementary Application for Import of Medicinal Materials; if the application is unqualified, it shall issue a Notification Document on Examination Opinions and explain the reasons therefor.

Article 26

The valid period of an Approval Document for Supplementary Application for Import of Medicinal Materials shall be the same as that of the original approval document.

Article 27

Where an applicant has any objection to the disapproval decision made by the State Food and Drug Administration, it may, within 10 days as of the date of receipt of the disapproval notice, file a written application for review with the State Food and Drug Administration and explain the reasons for requesting the review.

The contents to be reviewed shall be only limited to the original matters in question and the original application documents.

Article 28

The State Food and Drug Administration shall, after receiving the application for review, review the application within the time limit of and pursuant to the requirements for examination of the original matters in question, and make a review decision. If it cancels a disapproval decision, it shall issue to the applicant the corresponding Approval Document for Import of Medicinal Materials or Approval Document for the Supplementary Application for Import of Medicinal Materials; while if it sustains the original decision, it shall not accept a second application for review.

Article 29

Where, for the sake of review, it is necessary to inspect the samples or review the quality standards, such inspection or review shall be made within the time limit of and pursuant to the requirements for the original sample inspection or re-check of quality standards.

Chapter III Registration and Record keeping

Article 30

After obtaining the Approval Document for Import of Medicinal Materials, an applicant shall organize the import of medicinal materials at the port of arrival as stated in the Approval Document for Import of Medicinal Materials.

To organize the import of medicinal materials, the applicant shall have the documents registered and filed with the port or border port drug (food) administration, fill in a Report List for Inspection of the Imported Medicinal Materials, and submit the relevant documents.

Article 31

The port or border port drug (food) administration shall examine the completeness, conformity and authenticity of the documents registered and filed, and make an examination decision on the very day. If the documents are qualified, it shall issue a List of Customs Clearance of the Imported Drugs, take back the one-off approval document; and meanwhile send a Notification for Port Inspection of Imported Medicinal Materials to the drug inspection institution approved by the State Food and Drug Administration with a whole set of the registered and filed documents enclosed; if the documents are unqualified, it shall issue a Notification on Refusing to Register and File the Import of Medicinal Materials, and explain the reasons therefor.

Article 32

An applicant shall return the imported medicinal materials, the registration and record keeping of which is not approved. If they are unable to be returned, the port or border port drug (food) administration shall supervise and dispose of them according to the relevant legal provisions.

Chapter IV Port Inspections, Supervision and Administration

Article 33

The drug inspection institution as approved by the State Food and Drug Administration shall, within 2 days as of the date of receipt of the Notification for Port Inspection of Imported Medicinal Materials and in accordance with the Provisions on Sampling of Imported Medicinal Materials, make a on-site sampling at the prescribed storage place. At the time of on-site sampling, the applicant shall provide the original of the certificate of origin of the medicinal materials.

Article 34

The drug inspection institution as approved by the State Food and Drug Administration shall, on the basis of the registered and filed documents provided by the port or border port drug (food) administration, check the original of the certificate of origin of the medicinal materials, and check whether the medicinal materials have actually arrived. If the documents are qualified, it shall make the sampling, fill in a List of Sampling Records on the Imported Medicinal Materials, indicate the word "sampled" on the List of Customs Clearance of the Imported Drugs, and affix the seal of the sampling institution on it. If the documents are unqualified, it shall refuse to make the sampling, and send a Notification on Refusing to Sample the Imported Medicinal Materials to the local port or border port drug (food) administration within 2 days.

The port or border port drug (food) administration shall, after receiving the Notification on Refusing to Sample the Imported Medicinal Materials, take administrative enforcement measures against all the imported medicinal materials, such as seizure and impoundage, and shall make a decision in this regard within 7 days.

Article 35

The drug inspection institution as approved by the State Food and Drug Administration shall, within 20 days after the sampling, finish the inspection, issue an Inspection Report on the Imported Medicinal Materials, submit it to the local port or border port drug (food) administration and notify the applicant. If it is unable to finish the inspection within the prescribed time limit, it shall report to the port or border port drug (food) administration and notify the applicant.

Article 36

For the imported medicinal materials that fail to meet the standards upon inspections, the port or border port drug (food) administration shall, after receiving the inspection report, immediately take administrative enforcement measures such as seizure or impoundage of the imported medicinal materials , and shall make an administrative decision in this regard within 7 days. In case an application is filed for the re-inspection of the imported medicinal materials, it must make an administrative decision within 15 days as of issuance of the re-inspection conclusion. Meanwhile, it shall report the relevant information to the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where it is located. The applicant shall, within 2 days as of the date of receipt of the inspection report, give a detailed explanation in writing of the circulation and use of all imported medicinal materials to the local port or border port drug (food) administration.

Article 37

Where an applicant has any objection to the inspection result, it may apply for re-inspection pursuant to Article 67 of the Drug Administration Law. The drug inspection institution shall timely report to the port or border port drug (food) administration after accepting the application for re-inspection, and shall, within 20 days after accepting the application for re-inspection, draw a re-inspection conclusion, report it to the port or border port drug(food) administration and notify the applicant of the conclusion.

Article 38

For the imported medicinal materials which are found to meet the standards upon re-inspection, the port or border port drug (food) administration shall, upon receipt of the re-inspection conclusion, immediately relieve the administrative measures such as seizure or impoundage, and report it to the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where it is located.

Article 39

For the imported medicinal materials for which the applicant fails to apply for re-inspection within the prescribed time or which are found to still fail to meet the standards upon re-inspection, the port or border port drug (food) administration shall legally make an administrative decision in this regard, take corresponding measures, and meanwhile report it to the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where it is located.

Article 40

The medicinal materials initially imported may not be sold or used until they have been found to be qualified upon the inspection conducted by means of sampling by the drug inspection institution as approved by the State Food and Drug Administration.

Article 41

For the imported medicinal materials which are found to fail the standards upon inspection but have moved out of the jurisdiction of the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where the port or border port is located, the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where the port or border port is located shall timely communicate the relevant information to the drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where the medicinal materials flow into. The drug (food) administration of the province, autonomous region, or municipality directly under the Central Government where the medicinal materials flow into shall take corresponding measures according to law.

Article 42

The packing of imported medicinal materials must satisfy the quality requirements on imported medicinal materials, and be convenient for storage, transport and import inspection. Each package of the goods must give a clear indication of the Chinese name of the medicinal materials, the approval document number, the place of origin, the shipping mark, the name of the applying enterprise, the name of the exporter, the port of arrival, the weight and the date of processing and that of packing, etc.

Chapter V Legal Liabilities

Article 43

Where any of the circumstances as provided for in Article 69 of the Administrative License Law arises, the State Food and Drug Administration may, upon the strength of its capacity or at the interested party's request, revoke the relevant proof document on approval of the imported medicinal materials.

Article 44

Where any of the following circumstances arises in the process of examination and approval, registration and record keeping, or port inspection of certain imported medicinal materials, it shall be dealt with in accordance with Articles 72 through 75 of the Administrative Licensing Law:

(1)

An application for import of medicinal materials, which meets the legal conditions, is not accepted;

(2)

The items of application documents for import of medicinal materials are not made public at the acceptance place;

(3)

The drug (food) administration fails to perform the legal obligation of informing the applicant in the process of acceptance and examination;

(4)

The application documents submitted by the applicant are not complete or do not conform to the legal form, but the drug (food) administration fails to inform the applicant of the contents to be supplemented once for all;

(5)

The drug (food) administration fails to explain the reason for refusal or disapproval of the application;

(6)

For an application for import of medicinal materials that does not comply with the present Measures, the drug (food) administration makes an approval decision, or makes an approval decision by exceeding its legitimate authority;

(7)

For an application for import of medicinal materials that complies with the present Measures, the drug (food) administration makes a disapproval decision, or fails to make an approval decision within the time limit prescribed in the present Measures;

(8)

The drug (food) administration charges fees without approval or charges fees not according to the prescribed items and fee-charging rates; or

(9)

Any staff member of the drug (food) administration asks for or accepts others' properties or seeks other benefits.

Article 45

Where an applicant conceals any relevant information or provides any false material or sample to apply for the initial import of medicinal materials, the State Food and Drug Administration shall refuse to accept or approve this application, give the applicant a warning, and shall not accept its application for import of medicinal materials within one year.

Article 46

Where an applicant obtains the Approval Document for Import of Medicinal Materials by providing any false proof, document or sample, or by other fraudulent means, the State Food and Drug Administration shall revoke the Approval Document for Import of Medicinal Materials, shall not accept its application for the import of medicinal materials within five years, and shall impose upon it a fine of not less than 10,000 Yuan but not more than 30,000 Yuan.

Where an applicant obtains an Approval Document for Import of Medicinal Materials by offering bribery or by other improper means, the State Food and Drug Administration shall revoke the Approval Document for Import of Medicinal Materials, and shall not accept its application for the import of medicinal materials within three years.

Article 47

Where a drug inspection institution approved by the State Food and Drug Administration issues a false inspection report or illegally charges inspection fees when undertaking a port inspection, it shall be punished according to Article 87 and Article 96 of the Drug Administration Law.

Chapter VI Supplementary Provisions

Article 48

The time periods as provided for in the present Measures shall be counted by working days, excluding legal holidays.

The term "Initial import of medicinal materials" shall refer to the import of medicinal materials from a certain place of origin outside China for the first time.

The term "Medicinal materials with legal standards" shall refer to the medicinal materials for which there have already been national drug standards or the medicinal material standards of the province, autonomous region, or municipality directly under the Central Government.

The term "Medicinal materials without legal standards" shall refer to the medicinal materials for which there are no national drug standards or the medicinal material standards of the province, autonomous region, or municipality directly under the Central Government, but they are included in the Chinese traditional patent medicine prescriptions as approved by the state.

Article 49

The present Measures shall go into effect as of February 1, 2006.

Where any relevant provisions on imported medicinal materials which were promulgated prior to the implementation of the present Measures are inconsistent with the present Measures, they shall be suspended from implementation from the day when the present Measures go into effect.