Provisions for Crude Drugs Importation

Provisions for Crude Drugs Importation

(Promulgated by Decree No. 9 of the State Administration for Market Regulation on May 16, 2019)

Chapter I General Provisions

Article 1 In order to strengthen the supervision and administration of crude drugs importation and ensure their quality, these Provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China and other laws and regulations.

Article 2 The Provisions are applicable to the application, approval, filing, port testing as well as supervision and administration of crude drugs importation.

Article 3 Crude drugs shall be imported via the ports where drug import is permitted or the border ports where crude drugs importation is permitted by the State Council.

Article 4 The National Medical Products Administration (NMPA) shall be responsible for the supervision and administration of crude drugs importation nationwide. The NMPA shall entrust drug regulatory department of provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as provincial drug regulatory department) to implement the review and approval for first importation of crude drugs, and supervise and guide the acts of review and approval of first importation of crude drugs under entrustment.

Provincial drug regulatory department shall supervise and manage the crude drugs importation according to laws and conduct the review and approval of first importation of crude drugs in the name of the NMPA within the scope of entrustment.

Drug regulatory department where the ports allowing drug importation or where the border ports allowing the crude drugs importation are located (hereinafter referred to as drug regulatory department of ports) shall be responsible for the filing of crude drugs importation, organize the port testing and supervision and administration.

Article 5 The crude drugs importer in the Provisions refers to the applicant applying for the review and approval of first importation of crude drugs, or the unit applying for the filing of importation of crude drugs.

The crude drug importers shall be the marketing authorization holders (MAHs) of Chinese patent medicines, manufacturers of TCMs and drug distributors with the business scope covering Chinese crude drugs or Prepared Slices within the territory of China.

Article 6 For the first importation of crude drugs, its approval shall be obtained according to the Provisions, and such filing shall be applied to the drug regulatory department of ports. First crude drugs importation refers to those crude drugs that are not from the same country (region), the same applicant or the same origin.

Non-first importation of crude drugs shall be filed directly at drug regulatory department of ports according to the Provisions. Catalogue management shall be implemented for non-first import drugs, and the specific catalogue shall be formulated and adjusted by the NMPA. Those not yet included in the Catalogue but with no change of the applicant, origin or country (region) shall be managed as non-first import drugs.

Article 7 The crude drugs imported shall comply with national drug standards. For varieties not included in the current edition of the Pharmacopoeia of the People's Republic of China, the standards for importation of crude drugs shall be implemented; for varieties neither included in the current edition of the Pharmacopoeia of the People's Republic of China nor in the standards for importation of crude drugs, other national drug standards shall be implemented. In ethnic minority areas, the importation of locally customarily used ethnic drugs shall, in the absence of national drug standards, conform to the standards for crude drug of the corresponding province or autonomous region.

Chapter II Application and Approval of First Importation of Crude Drugs

Article 8 For the first importation of crude drugs, the applicant shall fill out the Application Form for Crude Drugs Importation through the information system of NMPA (hereinafter referred to as the "information system") and submit the following data to the local provincial drug regulatory department:

(I) Application Form for Crude Drugs Importation;

(II) A copy of the Drug Manufacturing Certificate or Drug Distribution Certificate, and if the applicant is the MAH of Chinese patent medicine, a copy of relevant drug approval document shall be provided;

(III) A copy of the entity registration certificate of the exporter;

(IV) A copy of the purchase contract and the notary document thereof;

(V) Information on the crude drugs' ecological environment, resource reserves, wild or planting and breeding conditions, harvest and primary processing at the place of production;

(VI) Crude drug standards and source of standards;

(VII) The original identification certificate for the origin of crude drugs issued by the institutions with the identification qualification for the origin of animals or plants within the territory of China that contains the identification basis, identification conclusion, picture of samples, identifier, identification institution and its official seal and other information.

The applicant shall be responsible for the authenticity of application dossiers.

Article 9 Provincial drug regulatory department shall conduct preliminary review on the normalization and completeness of application dossiers upon the receipt of application dossiers for first importation of crude drugs. Where application dossiers have errors which can be corrected on site, the applicant shall be allowed for error correction on site; where application dossiers are incomplete or does not comply with the defined format, the applicant shall be informed on-site or within 5 days of what to be supplemented or corrected all at once; if the applicant is not informed within the regulatory timeline, the application is regarded as accepted on the date the dossiers are received.

If the provincial drug regulatory department accepts or rejects the application for first importation of crude drugs, it shall issue a Notice of Acceptance or Rejection; if the application is rejected, it shall state the reasons in written form.

Article 10 The applicant shall, upon receipt of the Notice of Acceptance of first importation of crude drugs, submit the test samples to the local provincial drug control institution in time and submit the materials stipulated in Article 8 herein.

Article 11 Provincial drug control institutions shall, within 30 days upon the receipt of test samples and related materials, complete the sample testing, issue the testing report of imported drugs to the applicants, and submit it to the provincial drug regulatory department. Where it is necessary to extend the testing time due to characteristics of varieties or testing items, the duration and reasons of the extension shall be reported to provincial drug regulatory department in written form and notified to the applicants.

Article 12 In the case of any objection to the testing results, the applicant may apply for re-testing in accordance with the provisions of the Drug Administration Law. Drug control institutions shall, within 20 days upon the acceptance of the application for re-testing, draw a re-testing conclusion, report to provincial drug regulatory department and notify the applicants.

Article 13 Where provincial drug regulatory department deems it is necessary for the applicants to provide supplementary materials during the approval process, the required supplementary materials shall be notified all at once.

The applicant shall, within 4 months upon the receipt of the notice of required supplementary materials, provide the supplementary materials in a single delivery as required. Where the supplementary materials fail to be submitted within the regulatory timeline, a decision of disapproval shall be made. In case of failing to submit the supplementary materials within the regulatory timeline due to force majeure or other reasons, the applicant shall submit application for extension to local provincial drug regulatory department and explain the reasons.

Article 14 The provincial drug regulatory department shall make a decision of approval or disapproval within 20 days upon the acceptance of the application. For those meeting the requirements, a one-time approval document for importation of crude drugs shall be issued. The time for testing and submission of supplementary materials shall not be counted in the timeline for approval.

Article 15 In the case of any change of the approved items in approval document for importation of crude drugs, the applicant shall fill out the Supplementary Application Form for Crude Drugs Importation through the information system and submit the supplementary application to the original provincial drug regulatory department that issued the approval document. The applicant of supplementary application shall be the holder of the original approval document for imported drugs, and submit the following materials:

(I) Supplementary Application Form for Crude Drug Importation;

(II) Original approval document for crude drug importation;

(III) Materials related to change items.

Where there is any change of the name of the applicant, in addition to materials specified in the first paragraph, a copy of the applicant's Drug Manufacturing Certificate or Drug Distribution Certificate and the copy of the amendment sheet, or a copy of the drug approval document and the approval document for the supplementary application for the change of the name of MAH shall be submitted.

Where the applicant changes the port of arrival, in addition to materials specified in the first paragraph, the applicant shall also submit a copy of the purchase contract and the notarial document thereof.

Article 16 The provincial drug regulatory department shall complete the review and approval within 20 days after the acceptance of supplementary application. For those meeting the requirements, the approval document for supplementary application for crude drugs importation shall be issued.

Article 17 Where the provincial drug regulatory department decides to grant approval, it shall, within 10 days after the decision of approval is made, serve the approval document for crude drugs importation or for supplementary application for crude drugs importation to the applicant; where the drug regulatory department decides to grant disapproval, it shall, within 10 days after the decision of disapproval is made, serve a Notice of Review Opinions to the applicant with the reasons explained, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative suit according to law.