Decree of State Food and Drug Administration

Chapter III Port Testing

Article 20 Drug control institutes of port shall be designated by the State Food and Drug Administration according to the demand of port testing of drugs to be imported. The responsibilities of a drug control institute of port include:

(I) carrying out on-site examination of the goods arriving at port;

(II) verifying the original Certificate of Analysis for release and Certificate of Origin;

(III) taking samples as prescribed;

(IV) imposing port testing on drugs to be imported;

(V)  carrying out a verification test when the testing result is objected; and

(VI) handling other matters specified by State Food and Drug Administration.

Article 21 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for guiding and coordinating the port testing for drugs to be imported. The biological reference standard and chemical reference substance required for port testing shall be reviewed and characterized by the National Institute for the Control of Pharmaceutical and Biological Products.

Article 22 Drug control institutes of port shall test the import drugs in accordance with the registration standards as specified in the Import Drug License (or the Pharmaceutical Product License).

Article 23 Drug control institutes of port shall, within two days after receiving the Notice of Port Testing for Import Drugs, contact the importer, and carry out on-site sampling at the specified storage location in accordance with the Rules for Import Drugs Sampling.

The importer shall, before sampling, provide the original Certificate of Analysis for release and Certificate of Origin.

Where the sampling location is at customs surveillance area, the drug control institute of port shall contact the customs at the same time for sampling matters and ask for approval from the customs. When taking samples, both the importer and the customs officials shall be present on-site.

Article 24 When carrying out on-site sampling, the drug control institute of port shall impose close inspection on the actual condition of the imported drugs upon arrival, make sampling records, and fill in the Record of Sampling for Import Drugs.

In the case of drugs other than those specified in Article 10 of the Provisions, when sampling is completed, the drug control institute of port shall indicate "Sampled" on the original Import Drug Note held by the importer, and affix the seal of sampling entity.

In the case of the narcotic drugs and psychotropic substances, when sampling is completed, the drug control institute of port shall indicate "Sampled" on the Import License, and affix the seal of sampling entity.

Article 25 Drug control institutes of port shall not take samples on drugs to be imported in any of the following cases:

(I) the original Certificate of Analysis for release and Certificate of Origin is not provided, or the original copy provided is inconsistent with the photocopies submitted at the time of importation record filing;

(II) the shipping marks are not in conformity with the documents;

(III) the batch number or quantity of the drug to be imported is not in conformity with the documents;

(IV) the packaging and labeling of drugs to be imported is inconsistent with the documents; and

(V) the drug regulatory department has other evidence proving that the drug to be imported may damage people's health.

As to drugs from which no sample shall be taken, the drug control institute of port shall within 2 days deliver the Record of Sampling for Import Drugs to the local drug regulatory department at ports of entry.

Article 26 Drug control institutes of port shall test the samples taken without delay, complete testing within 20 days after sampling, and issue the Report of Testing for Import Drugs. If the testing cannot be completed on time due to special varieties or special circumstances, the time limit for testing may be appropriately extended, where the importer and the drug regulatory department at ports of entry shall be notified.

The Report of Testing for Import Drugs shall clearly indicate testing conclusion such as "up to relevant standards" or "not up to relevant standards".

In the case of biological products subject to lot release specified by the State Food and Drug Administration, if a batch of biological products meets relevant standards based on port testing and conforms to the requirements according to examination, a certificate of lot release for that batch shall also be issued at the same time.

Article 27 If drugs to be imported conform to relevant standards based on testing, the drug control institute of port shall deliver the Report of Testing for Import Drugs to the local drug regulatory department at ports of entry and the importer.

If drugs to be imported fail to meet relevant standards based on testing, the drug control institute of port shall promptly deliver the Report of Testing for Import Drugs to the local drug regulatory department at ports of entry and other drug control institutes of port, and shall, at the same time, report to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.

Article 28 The samples for testing of drugs to be imported shall be kept until the expiry date. Retained samples which are not easy to be stored may be kept for a period of time according to the actual situation. Any retained sample of goods which are claimed for compensation or asked to be returned shall be kept until the end of the relevant case. Any reserved sample which pasts its date of expiry shall be disposed by the drug control institute of port and recorded for archiving.

Article 29 Where an importer has objections to the testing result, it may, within seven days since the day of receiving such testing result, apply to the original drug control institute of port for a verification test, or directly apply to the National Institute for the Control of Pharmaceutical and Biological Products for a verification test. The verification test of biological products shall be directly applied to the National Institute for the Control of Pharmaceutical and Biological Products.

The drug control institute of port shall promptly notify the drug regulatory department at ports of entry, and shall, within 10 days after accepting the application for verification test, draw a conclusion on the verification test, notify the drug regulatory department at ports of entry and other drug control institutes of port, and submit it to the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.

Chapter IV Supervision and Administration

Article 30 As to drugs which no samples shall be taken by the drug control institute of port in accordance with the regulations of Article 25 of the Provisions but having gone through the procedures of customs examination and release, the drug regulatory department at ports of entry shall take administrative enforcement measures to seize and detain all of such drugs to be imported.

Article 31 In the case of drugs other than those specified in Article 10 of the Provisions, if they fail to meet relevant standards based on testing by the drug control institute of port, the importer shall within 2 days after receiving the Report of Testing for Import Drugs, report the detailed information on the circulation and use of all such imported drugs to the local drug regulatory department at ports of entry.

Upon receipt of the Report of Testing for Import Drugs, the local drug regulatory department at ports of entry shall promptly take administrative enforcement measures to seize and detain all such drugs, and make an administrative handling decision within 7 days. In the case of applying for verification test, an administrative handling decision must be made within 15 days since the day of issuing the testing report. Relevant information shall be reported to the State Food and Drug Administration in a timely manner and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

Article 32 Where no application for verification testis submitted within the prescribed time or the drug still fails to meet relevant standards based on the verification test, drug regulatory department at ports of entry shall make an administrative handling decision in accordance with the Drug Administration Law and relevant regulations. Relevant information shall be reported to the State Food and Drug Administration in a timely manner and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

If the drug meets relevant standards based on verification test, the drug regulatory department at ports of entry shall lift the administrative enforcement measures such as seizure and detention, and report the handling situation to the State Food and Drug Administration and at the same time to the drug regulatory department of each province, autonomous region and municipality directly under the central government and to other drug regulatory departments at ports of entry.

Article 33 Other issues found in the record filing of drugs to be imported shall be disposed of by the drug regulatory departments at ports of entry in accordance with the Drug Administration Law and relevant regulations.

Article 34 Where a domestic drug manufacturer, distributor or medical institution purchases imported drugs, the supplier shall provide the following materials at the same time:

(I) photocopies of the Import Drug License (or the Pharmaceutical Product License) or photocopies of Import Drug Approval; and

(II) photocopies of the Report of Import Drug Testing or photocopies of the Import Drug Note marked with "Sampled" and affixed with the official seal.

In the case of the biological products subject to lot release specified by the State Food and Drug Administration, photocopies of the certificate of lot release examined and issued by drug control institutes of port shall also be provided at the same time.

When importing narcotic drugs and psychotropic substances, photocopies of the Import Drug License (or the Pharmaceutical Product License), photocopies of the Import License and photocopies of the Report of Testing for Import Drugs shall be provided at the same time.

Each photocopy of the above-mentioned documents shall be affixed with the seal of the supplier.

Article 35 Drug regulatory departments at ports of entry and drug control institutes of port shall establish a strict management system for the materials of importation record filing and the materials of port testing, and shall be responsible for the confidentiality of the materials submitted by importers.

Article 36 The State Food and Drug Administration shall, based on the seriousness of the circumstances, criticize or circulate a notice of criticism to the drug regulatory department at ports of entry or the drug control institute of port which violates relevant provisions for importation record filing and port testing, and shall suspend its qualification with respect to importation record filing and port testing if the circumstances are serious.

Article 37 In the case of violating any relevant provisions related to customs as specified in the Provisions, the customs shall dispose the violation in accordance with the regulations of the Customs Law and the Regulations of the People’s Republic of China on Implementing Customs Administrative Penalty.