Measures for the Administration of Imported Drugs
(State Drug Administration Order No. 6)
Chapter 1 General Provisions
Article 1 In order to strengthen the supervision and management of imported drugs and ensure the quality, safety and effectiveness of imported drugs, these Measures are formulated in accordance with the provisions of the Drug Administration Law of the People's Republic of China.
Article 2 The state implements a registration and approval system for imported drugs. Imported drugs must obtain the "Import Drug Registration Certificate" issued by the State Drug Administration of the People's Republic of China and pass the inspection by the port drug inspection institute authorized by the State Drug Administration.
Article 3 The State Food and Drug Administration is responsible for the approval, supervision and management of imported drugs, and local drug regulatory departments at all levels are responsible for the supervision and management of imported drugs within their jurisdiction.
Article 4 Imported drugs must comply with the provisions of the "Drug Administration Law of the People's Republic of China" and other relevant Chinese laws and regulations, and must accept the supervision and inspection of their production by the State Drug Administration.
Article 5: Imported drugs must be clinically needed, safe and effective, and have controllable quality.
Chapter 2 Application and Registration Approval
Article 6 Imported drugs applying for registration must obtain registration approval and marketing authorization from the national drug competent authority of the country of production.
Article 7 The manufacturing plant of imported drugs must comply with the requirements of the country’s Good Manufacturing Practices and China’s Good Manufacturing Practices (GMP). If necessary, it must be verified by the State Food and Drug Administration to meet the requirements. Production conditions and management levels suitable for the varieties produced.
Article 8 For registration of imported drugs, an application must be submitted by the office of a foreign pharmaceutical manufacturer in China or its registered agent in China, and the "Application Form for Imported Drug Registration Certificate" must be filled in together with the information specified in these measures. , submitted to the State Food and Drug Administration for approval.
The offices of foreign pharmaceutical manufacturers in China or their registered agents in China must be legal institutions registered with the Chinese industrial and commercial administration department.
Article 9 To apply for registration of imported drugs, the following information must be submitted:
(1) The national drug authority of the drug producing country approves drug registration, production, sales, export and production Proof and notarization documents proving that the factory complies with Good Manufacturing Practices (GMP).
(2) Documents proving that the foreign pharmaceutical manufacturer authorizes the Chinese agent to declare as an agent, a copy of the Chinese agent's industrial and commercial license; a copy of the registration certificate of the foreign pharmaceutical manufacturer's permanent representative office in China.
(3) Drug patent certification documents.
(4) Drug instructions approved by the national drug authority of the country where the drug is produced.
(5) Drug quality standards and inspection methods.
(6) A review of the results of various drug studies.
(7) Detailed technical information such as drug prescription, production process, pharmacology, toxicology and clinical research.
(8) Samples of drugs and packaging and other information.
The specific requirements for application materials shall be implemented in accordance with the "Detailed Rules for Application Materials for Imported Drugs" (Annex 1) attached to these Measures.
Article 10: Imported drugs applied for registration must undergo quality review in accordance with the requirements and procedures of the "Imported Drug Quality Review Rules" (Annex 2) attached to these Measures.
Article 11: Imported drugs applying for registration must undergo clinical research (including bioequivalence testing) in China in accordance with the procedures and requirements prescribed by the State Food and Drug Administration. If the API applied for registration has not yet been produced in China, preparations made from the API will be used for clinical research in China. Clinical research must be carried out in accordance with China's "New Drug Approval Measures" and "Good Clinical Practice" (GCP). Special diseases or other circumstances that require exemption from clinical research must be reviewed and approved by the State Food and Drug Administration.
Article 12 After the quality review and clinical research of the applied variety are completed, the State Food and Drug Administration will review the relevant information and issue an "Imported Drug Registration Certificate" if the requirements are met. The quality standard of this variety becomes the registration standard for imported drugs, and the Chinese instructions are the statutory instructions for guiding the clinical use of imported drugs in China.
Article 13: For drugs for the treatment of special diseases, if there are no other alternative drugs in China, the State Food and Drug Administration may take measures to expedite the approval.
Article 14: Drugs needed for major disasters and epidemics in China, special clinical needs and urgently needed drugs, donated drugs and research samples, etc., without obtaining the "Import Drug Registration Certificate", can be obtained through the national The Food and Drug Administration specifically approves the import. Such medicines may only be used within specific limits for specific purposes.
Article 15: The import registration application for drugs under any of the following circumstances will not be approved:
(1) Those that do not comply with the provisions of Articles 6 and 7 of these Measures ;
(2) The application materials do not meet China’s imported drug registration and approval requirements;
(3) There are serious adverse reactions during clinical use;
( 4) The clinical efficacy is inaccurate or the reported clinical research data cannot explain the exact efficacy of the drug;
(5) The quality standards and inspection methods are imperfect, and the quality indicators are lower than China’s national drug standards and China’s biological products regulations or international pharmacopoeia and registered enterprise standards for similar varieties;
(6) Containing ingredients that are prohibited from being imported into China;
(7) Others that do not comply with relevant Chinese laws, regulations and regulations.
Chapter 3 Imported Drug Registration Certificate
Article 16 "Imported Drug Registration Certificate" is issued by the State Food and Drug Administration to allow foreign-produced drugs to be registered, imported and Approval document for sale use. All port drug inspection offices of the State Food and Drug Administration accept applications for inspection with the "Imported Drug Registration Certificate".
Article 17 The "Imported Drug Registration Certificate" is divided into original and duplicate. It is valid for three years from the date of issuance of the certificate.
Article 18 The "Imported Drug Registration Certificate" is numbered in a unified format and is the registration certificate number. The registration certificate number consists of the letter
Article 19 The "Imported Drug Registration Certificate" stipulates the following contents: generic name of the drug, trade name, main ingredients, and dosage form. Specifications, packaging specifications, drug validity period; company, manufacturer name and address; registration certificate validity period, inspection standards, registration certificate number, approval time, licensing authority and seal, etc.
For each different specification of the approved registered variety, an "Import Drug Registration Certificate" will be issued separately; each "Import Drug Registration Certificate" can contain up to two packaging specifications.
Article 20 The "Imported Drug Registration Certificate" is only valid for the content stated, and any changes to its content must be reported to the State Food and Drug Administration for review and approval.
Article 21: For some raw materials, excipients, and semi-finished preparations approved for import registration, the State Food and Drug Administration will limit the scope of use in the remarks on the "Imported Drug Registration Certificate".
Chapter 4 Renewal and Approval of the "Imported Drug Registration Certificate"
Article 22 The renewal of the "Imported Drug Registration Certificate" shall be handled by the offices of foreign pharmaceutical manufacturers in China The institution or its registered agent in China shall submit an application to the National Medical Products Administration six months before the expiration of the registration certificate. Those that have exceeded the validity period of the registration certificate will be managed as newly applied registered varieties.
Article 23 To apply for the renewal of the "Imported Drug Registration Certificate", you must fill in the "Application Form for Renewal of the Imported Drug Registration Certificate" and submit the following information:
(1) A document issued by the national drug authority of the country of drug production approving drug registration, production, sales, export and compliance with Good Manufacturing Practices (GMP).
(2) Documents proving that the foreign pharmaceutical manufacturer authorizes the Chinese agent to declare as an agent, a copy of the Chinese agent's industrial and commercial license; a copy of the registration certificate of the foreign pharmaceutical manufacturer's permanent representative office in China.
(3) Drug instructions approved by the national drug regulatory authority of the country where the drug is produced and its Chinese translation.
(4) Drug prescriptions, production processes, quality standards and inspection methods.
(5) Import and sales status in China during the validity period of the "Imported Drug Registration Certificate" (including import batches, quantities, import ports, etc.).
(6) Summary report on the use and adverse reactions of imported drugs.
(7) Samples of drugs and packaging and other information.
The specific requirements for application materials shall be implemented in accordance with the "Detailed Rules for Application Materials for Imported Drugs".
Article 24 If there are changes in excipients, production processes, quality standards, instructions, etc. in drug prescriptions, the following information must be submitted at the same time:
(1) Reasons for the modification and its illustrate.
(2) Documentation proving the approval of this modification by the national drug regulatory authority of the country of production.
(3) Experimental research data on which this modification is based.
Article 25 The State Food and Drug Administration will review the varieties that apply for renewal of the "Import Drug Registration Certificate". If necessary, it can arrange quality assessment or clinical re-evaluation. If the requirements are met, the renewal will be approved. Issue an "Imported Drug Registration Certificate" and a new registration certificate number.
Article 26: For imported drugs that fall under any of the following circumstances, the application for renewal of the "Import Drug Registration Certificate" will not be approved:
(1) Serious adverse reactions are found
(2) The clinical efficacy is inaccurate and the quality is unstable;
(3) The second batch of failed port inspections;
(4) Those who have been punished by the State Food and Drug Administration for more than two times (including two times);
(5) Others that do not comply with relevant Chinese laws, regulations and regulations.
Chapter 5 Supplementary Application
Article 27 For imported drugs that have obtained the "Import Drug Registration Certificate", the following situations are supplementary applications.
(1) Changes in the generic name, trade name, company name, manufacturer name, etc. stated in the "Imported Drug Registration Certificate".
(2) Changes in quality standards, production processes, validity periods, etc.
(3) Increased indications.
(4) Changes in the content of the instruction manual.
(5) Changes in packaging and label styles and contents.
(6) Changes in excipients in the prescription.
(7) Change of origin.
(8) Changes or additions to drug specifications.
(9) Packaging specifications are changed or added.
(10) Any other changes to the declared content when the registration was approved.
Article 28 The supplementary application must fill out the "Supplementary Application Form for Imported Drugs", together with the supplementary application materials specified in the "Detailed Rules for Application Materials for Imported Drugs", and submit it to the State Food and Drug Administration for review and approval.
Article 29 When applying for additional indications, clinical trials must be conducted in China; if drug quality standards are changed, quality standards review must be conducted.
Article 30 A supplementary application for changing the place of origin or adding drug specifications must be submitted at least 12 months before the expiration of the original "Imported Drug Registration Certificate"; if it is less than 12 months, it can be submitted in accordance with the fourth step of these Measures. According to the provisions of the chapter, apply for the renewal of the "Imported Drug Registration Certificate", and at the same time apply for changing the place of origin and increasing drug specifications.
After the supplementary application for changing the place of origin and adding drug specifications is reviewed and approved by the State Food and Drug Administration, an "Import Drug Registration Certificate" for the new place of origin and added drug specifications will be issued. The new registration certificate number will be the original registration certificate. The number is formed by adding the letter B in front of it. The validity period of the registration certificate shall be based on the original registration certificate.
Article 31: Supplementary applications for content specified in the "Imported Drug Registration Certificate", such as changes to packaging specifications, common names, trade names, company names, manufacturer names, etc., shall be reviewed and approved by the State Food and Drug Administration After that, a new "Imported Drug Registration Certificate" will be issued, and the original registration certificate will be invalidated and taken back by the State Food and Drug Administration; a supplementary application for increasing packaging specifications, including the large packaging specifications required for imported sub-packaging production, will be issued by the State Food and Drug Administration. After review and approval, a new "Imported Drug Registration Certificate" will be issued, and the original registration certificate can continue to be used.
The new registration certificate number is composed of the original registration certificate number preceded by the letter B. The validity period of the registration certificate shall be based on the original registration certificate.
Article 32: After the supplementary application for Chinese instructions and quality standards for imported drugs is reviewed and approved by the State Food and Drug Administration, the revised instructions and quality standards will be issued, and the original instructions and quality standards will be abolished. .
Article 33 If there are only minor changes in the packaging and label style and content of imported drugs, they should be reported to the State Food and Drug Administration for filing.
Chapter 6 Drug Names, Packaging, Labels and Instructions
Article 34 Imported drugs must use Chinese drug names and must comply with the Chinese drug naming principles.
Article 35 The packaging and labels of imported drugs must indicate the drug name, main ingredients and registration certificate number in Chinese, and imported drugs must use Chinese instructions.
Article 36 The packaging, labels and instructions of imported drugs must comply with China's "Regulations on the Administration of Drug Packaging, Labels and Instructions" and must be used after approval by the State Food and Drug Administration. Once approved, its content may not be changed without authorization.
Chapter 7 Import Inspection
Article 37 The State Food and Drug Administration shall, in accordance with the needs of imported drug management, establish a port drug inspection office to be responsible for the port inspection of registered varieties. Work.
Article 38 The China Institute for the Control of Pharmaceutical and Biological Products is responsible for organizing, coordinating and guiding the inspection of imported drugs, and conducting technical arbitration on disputed inspection results. Its technical arbitration results on imported drugs are: Final conclusion.
Article 39: Imported drugs must be fully inspected batch by batch in accordance with the quality standards stated in the "Imported Drug Registration Certificate". The China Institute for the Control of Pharmaceutical and Biological Products is responsible for the unified preparation, calibration and distribution of standards and reference materials required for the inspection of imported drugs. The "Imported Drug Inspection Report" adopts a unified format.
Article 40 Imported drugs must be imported from the port organization in the city where the port drug inspection office is located. For imports from other ports, the drug inspection offices at each port shall not accept inspection.
Article 41 The import inspection of biological products shall be the responsibility of the China Institute for the Control of Pharmaceutical and Biological Products or the port drug inspection office authorized by the State Food and Drug Administration.
Article 42 After the imported drugs arrive at the port, the importing unit must fill in the "Imported Drug Inspection Form" (Annex 3), hold the original "Imported Drug Registration Certificate" (original or copy), and go to the place where the imported drugs are imported. The port drug inspection office shall apply for inspection and submit the following information:
(1) A copy of the "Import Drug Registration Certificate" for the declared variety stamped with the official seal of the importing unit.
(2) A copy of the "Pharmaceutical Business Enterprise License" stamped with the official seal of the importing unit.
(3) The original certificate of origin issued by the relevant department of the producing country as stated in the "Imported Drug Registration Certificate" for the declared variety.
(4) A copy of the purchase contract for the declared product.
(5) Packing list, waybill and freight invoice for the declared product.
(6) Factory inspection report of the declared variety.
(7) Chinese and English instructions, packaging, labels and samples of the declared variety.
(8) Other relevant information.
Preventive biological products and blood products must also issue the "Biological Products Import Approval" issued by the State Food and Drug Administration; imported medicinal materials must also issue the "Imported Medicinal Materials Approval" issued by the State Drug Administration.
Article 43: After receiving the "Import Drug Inspection Form", the port drug inspection office shall promptly check all the information submitted by the import unit and check the quantity of the drugs. If the requirements are met, issue an "Import Drug Inspection Form" Drug Registration Certificate" (Annex 4).
Article 44 Within 7 days after customs release, the importing unit shall report the delivered customs tax bill to the port drug inspection office and contact the storage location for on-site sampling. The port drug inspection office should check the quantity of all imported goods with the customs tax bill and complete the sampling, sign the "Imported Drug Sampling Record Sheet" (Annex 5), and seal all goods. Imported drugs that have not passed the inspection may not be opened, allocated and used without authorization.
Sampling of imported drugs shall be carried out in accordance with the "Regulations on Sampling of Imported Drugs" (Annex 6) and the "Regulations on Sampling of Imported Medicinal Materials" (Annex 7) of the State Food and Drug Administration.
Article 45: After sampling, the port drug inspection office shall conduct timely inspections and issue an "Imported Drug Inspection Report" within the specified time. The "Imported Drug Inspection Report" should clearly indicate the inspection conclusion of "Complies with regulations and is allowed to be imported" or "Does not comply with regulations and is not allowed to be imported". If a claim is required, an English "Imported Drug Inspection Report" should be issued promptly. Samples for import inspection are retained for two years.
Article 46: For imported drugs that meet the regulations, the port drug inspection office shall promptly unseal them and allow transfer, sale and use; imported drugs that do not meet the regulations shall be sealed on site.
Article 47 If the importing unit has objections to the inspection results, it shall apply to the original port drug inspection office for re-inspection within 30 days of receiving the "Imported Drug Inspection Report"; if the re-inspection results are still objectionable, If you have any objections, you can apply for arbitration inspection to the China Institute for the Control of Pharmaceutical and Biological Products within 30 days after receiving the re-test results.
If re-inspection is not applied or if the drug still fails to pass the arbitration, the unqualified drugs will be supervised and handled by the provincial drug regulatory bureau at the place where they are stored.
Article 48: For unqualified imported drugs detected, each port drug inspection institute must submit the inspection report to the State Food and Drug Administration and the China Institute for the Control of Pharmaceutical and Biological Products within 7 days, and send it to the National Institute of Pharmaceutical and Biological Products at the same time. Other port drug inspection institutes and provincial drug regulatory bureaus at the place of storage. The China Institute for the Control of Pharmaceutical and Biological Products shall summarize statistics on unqualified imported drugs last month and submit them to the State Food and Drug Administration in the first week of each month.
Article 49: Applications for inspection of imported drugs will not be accepted under any of the following circumstances:
(1) Failure to provide the "Import Drug Registration Certificate" (original or Copy), and the original "Approval Document for the Import of Biological Products" or "Approval Document for the Import of Medicinal Materials";
(2) The "Import Drug Registration Certificate" exceeds the validity period of 30 days;
(3) ) Failure to provide the original certificate of origin of the applied variety;
(4) The unit engaged in import business has not obtained the "Pharmaceutical Business Enterprise License";
(5) Declared varieties The packaging, labels, etc. are inconsistent with the "Imported Drug Registration Certificate";
(6) There are no Chinese instructions or the Chinese instructions are inconsistent with the approved instructions;
(7) Failure to comply with Imported at prescribed ports;
(8) When submitted for inspection, the pharmaceutical preparation is less than six months from its expiration date, and the bulk drug and excipients are less than twelve months from its expiration date;
(9) Forgery or alteration of relevant documents and bills;
(10) Others that do not comply with relevant regulations on the management of imported drugs.
Chapter 8 Supervision and Punishment
Article 50 Imported drugs must be produced and finally packaged in the production factory or packaging factory specified in the "Imported Drug Registration Certificate". It is not allowed to produce, change packaging, affix Chinese labels, or add Chinese instructions in other countries (or regions). In violation of the above provisions, the port drug inspection office will not accept the import inspection application for the drugs that have arrived.
Article 51: When domestic drug manufacturers, operating companies and medical units purchase imported drugs, the supplier must provide copies of the "Imported Drug Registration Certificate" and "Imported Drug Inspection Report". And stamped with the official seal of the supplier.
Article 52 Foreign pharmaceutical manufacturers that have obtained the "Imported Drug Registration Certificate" must promptly report adverse reactions that occur during the use of imported drugs in accordance with the relevant regulations on the supervision and management of adverse drug reactions of the State Drug Administration. , including adverse reactions occurring abroad. Foreign pharmaceutical manufacturers will be responsible for all consequences caused by failure to report adverse reactions to imported drugs as required.
Article 53: The sale and use of imported drugs under any of the following circumstances are prohibited:
(1) Failure to obtain the "Import Drug Registration Certificate" and "Biological Products Import Approval Document" "Or "Imported Medicinal Materials Approval";
(2) Forged or counterfeited "Imported Drug Registration Certificate", "Biological Products Import Approval" or "Medicinal Materials Import Approval";
< p> (3) Forging or counterfeiting the "Imported Drug Inspection Report" for sale.Article 54: The State Food and Drug Administration will issue a warning to foreign pharmaceutical manufacturers for imported drugs that fall under any of the following circumstances:
(1) A batch fails to pass the import inspection
(2) Failure to report adverse drug reactions in a timely manner;
(3) Changing packaging and labels without authorization;
(4) Packaging, The label does not indicate the "Imported Drug Registration Certificate" number and does not indicate the name and main ingredients of the drug in Chinese.
Article 55: The State Food and Drug Administration shall suspend import inspection of imported drugs under any of the following circumstances:
(1) More than two batches of imported drugs fail to pass the import inspection ;
(2) Failure to report adverse drug reactions in a timely manner, resulting in serious consequences;
(3) Changing the contents of the Chinese instructions approved by the State Food and Drug Administration without authorization;
(4) Being warned by the State Food and Drug Administration twice or more (including twice);
(5) Exceeding the scope of use limited by the "Imported Drug Registration Certificate";
(6) The production, sale and use have been stopped by foreign drug authorities;
(7) Other serious violations of China’s laws, regulations and provisions on drug management.
Chapter 9 Supplementary Provisions
Article 56: Imported drugs as mentioned in these Measures include, in addition to raw materials and preparations, semi-finished products and pharmaceutical excipients, etc.
Article 57 If the applicant has objections to the bureau’s imported drug registration review and approval conclusion, it may apply to the State Food and Drug Administration for review within one month.
Article 58: The import management of narcotic drugs, psychotropic drugs and radioactive drugs shall be implemented in accordance with the provisions of the "Administrative Measures for Narcotic Drugs", "Administrative Measures for Psychotropic Drugs" and "Administrative Measures for Radioactive Drugs" of the State Council.
Article 59: Where drugs produced in Hong Kong, Macao and Taiwan apply for sale and use in the mainland, a "Pharmaceutical Product Registration Certificate" shall be issued after approval by the State Food and Drug Administration in accordance with the provisions of these Measures. 》.
Article 60: Application for registration of imported drugs must be paid in accordance with relevant national regulations.
Article 61 The State Food and Drug Administration is responsible for the interpretation of these Measures.
Article 62 These Measures will come into effect on May 1, 1999. All regulations on the management of imported drugs shall be subject to these Measures.
Attachment 1:
Details of application materials for imported drugs
1. The application materials must comply with the attached "Application Materials for Registration of Imported Drugs" and "Application for Renewal" The data items and numbers specified in the "Imported Drug Registration Certificate Application Materials" and the "Imported Drug Supplementary Application Application Materials".
2. The "Imported Drug Registration Application Form" and "Imported Drug Registration Certificate Replacement Application Form" must be filled in in triplicate, and the "Imported Drug Supplementary Application Form" must be filled in in duplicate, except for signatures and stamps. Except for chapters, all content must be printed.
3. Application materials must be in Chinese or English. Information in other languages ??can be attached for reference. Application materials must be scientific, true and comprehensive. Any handwriting that is unclear, illegible or illegible will not be accepted. All types of Chinese translations must be faithful to the original text and comply with Chinese professional standards.
4. The certification documents of various foreign government drug authorities, prescriptions, quality standards, and drug instructions for the declared varieties must be translated into Chinese. Other research materials must provide Chinese summaries of each trial.
5. The application materials must be organized in the prescribed order of data numbers, and the data with different numbers should be bound separately. The name of the data should be marked on the cover of each piece of data, and the data number should be noted in the upper right corner. Chinese translations of the same material should be ranked before the original text. All information should be submitted on A4 paper.
6. The materials for newly applied registration varieties with numbers A0l to A05 are bound into one volume with the "Application Form for Registration of Imported Drugs", which is called "Volume 1". The application form is ranked before other materials; A06 to Al3 Items of data are bound into one volume as "Volume 2"; items A14 to A22 are "Volume 3"; items A23 to A26 are "Volume 4". The application materials for the renewal of the "Imported Drug Registration Certificate" and the supplementary application materials are bound into one volume in the order of the materials, and the application form is placed before other materials.
The cover of each volume of the application materials should be written in Chinese with the common name and trade name of the product being applied for, the production company, the applicant company, the date of application, and the volume number to which the volume belongs. The Chinese table of contents of the materials in this volume should be provided on the first page of each volume.
7. The original information of item A01 must be submitted and should comply with the unified format recommended by the World Health Organization (WHO). When necessary, the submitted documents must be notarized by the notary authority of the host country and the Chinese embassy or consulate in the host country.
1． Certification documents approved by regional international organizations for drug registration, production, sales and compliance with Good Manufacturing Practices (GMP), which are specifically recognized by the State Drug Administration and can be used as certification documents for a country.
2． If the preparation of the declared variety is completed in one place and is packaged in another place, a document certifying that the packaging plant complies with GMP signed by the competent drug authority of the country where the packaging plant is located must be provided.
3. If the product to be applied for preparations has not yet obtained registration approval and sales license in the country of production, certification documents issued by the country where the company is headquartered and at least one other country can be provided, but the GMP certification document must be signed by the drug competent authority of the country where the production plant is located.
4. For raw materials and excipients, according to the production country's management requirements for such products, if relevant certification documents cannot be provided, the production country or exporting country can provide certification documents for using the raw materials and excipients to make preparations, or provide other relevant government departments of the country. A document proving that the product has indeed been marketed for medicinal use.
5． The raw materials or semi-finished products applying for import registration are exclusively used by Chinese domestic drug manufacturers to produce Class I new drugs, and the company has obtained a domestic drug production approval number. The government certification documents for its registration and sales can be submitted to my country for approval. Copies of the drug's new drug certificate and new drug approval document, its GMP certification document and export certificate must be signed by the drug competent authority of the country where the foreign production plant is located.
6． If national-level certification documents cannot be provided for some over-the-counter (OTC) drugs and medical nutritional drugs, certification documents from the corresponding level of government departments may be provided in accordance with the laws and regulations of the producing and exporting countries.
8. If a foreign pharmaceutical manufacturer has not yet established an office in China, it must select a Chinese agent to declare on its behalf, and its A02 and H02 information should be submitted to the authorization document issued by the foreign pharmaceutical manufacturer authorizing the Chinese agent to declare on its behalf. , notarized documents and their Chinese translations, together with a copy of the Chinese agent's industrial and commercial license.
If a foreign pharmaceutical manufacturer has established an office in China, the office can apply directly, and its A02 and H02 information should be submitted to the office's "Foreign Enterprises Permanent in China" issued by the Chinese industrial and commercial administration department. Copy of Registration Certificate of Representative Office.
9. For first-time declaration of raw materials or semi-finished products, all technical data must be submitted. Among them, A23 and A24 data can be submitted for testing data on preparations made from this raw material or semi-finished products.
For APIs or semi-finished products of the same type that have been imported and registered for import, documentation on items A14 to A22 can be submitted. Information on items A23 and A24 must be submitted if the raw materials or semi-finished products are used to make preparations. For test data, only literature data shall not be used.
10. For pharmaceutical preparations submitted for the first time, all specified technical information must be submitted, and only literature information shall not be used.
For pharmaceutical preparations of the same type that have been imported and registered, literature materials for items A14 to A22 can be submitted, and test data for items A23 and A24 must be submitted for the applied species, and only literature materials are not allowed.
11. When applying for registration of pharmaceutical excipients, except for test items that cannot be carried out using excipients alone, information should be submitted with reference to the information requirements in these rules.
12. Information on items A06 and H03 of traditional medicines and natural medicines should indicate in detail the source of each original plant (animal) or mineral used in the prescription, and the family, genus, species and Latin name, English name.
13. When applying for import registration of raw materials and excipients, items A07 and H04 must describe their production technology and production process in detail.
14. The A09 and H06 information of biological products should include technical information such as bacterial and virus species, cell strains, animals used for production and verification, main raw materials, etc.
15. The information on Al2 and H09 is an inspection report conducted by the laboratory of the quality control department of the company that has the right to market the product, and shall be signed by the person in charge of the quality control department to take effect.
16. Item A13 is the stability test data of the room temperature retained samples of the three batches of samples of the registered variety and the stability test data of the accelerated test. All test data must be included, such as quality inspection reports and qualitative and quantitative chromatographic analysis charts, etc.
17. The A14 information of vaccine products includes immunological information.
18. Item A23 data, including clinical trials and human bioavailability/bioequivalence test data, among which clinical data should be phase I, phase II and phase III trial data, including clinical trial protocols and statistical methods; Phase IV clinical trial data can be declared as a reference.
19. Items A24 and H10 must provide English instructions approved by the drug regulatory authority of the country of production and attach a Chinese translation. Chinese instructions must be translated strictly according to the contents of the English instructions and comply with Chinese professional standards. If English is not the official language of the country of production and English information cannot be provided, the original instructions approved by the drug regulatory authority of the country of production must be provided, and its English translation and Chinese instructions must be provided.
20. Items A25 and H13 refer to the actual packaging, labels and instructions used by the drug in foreign markets, excluding the drug itself; Items A26 and H14 refer to the drugs sold in foreign markets. Actual samples, including packaging, labels, the drug itself and instructions inside the box.
21. The requirements for government certification documents and technical information in the supplementary application shall be implemented in accordance with the above regulations.
Application for imported drug registration application materials
A0l The national drug authority of the drug producing country approves drug registration, production, sales, export and its production plant to comply with the Good Manufacturing Practice (GMP) )'s certification documents, notarized documents and their Chinese translations
A02 Authorization documents, notarized documents and their Chinese translations for foreign pharmaceutical manufacturers authorizing Chinese agents to declare as agents, and a copy of the Chinese agent's industrial and commercial license; foreign pharmaceuticals Copy of the registration certificate of the manufacturer's permanent representative office in China
A03 Drug patent certification document
A04 The production, sales and use of the drug abroad, basic overview of the manufacturer and application in China Reasons for special explanations for registration and their Chinese translations
A05 Summary of drug research results and their Chinese translations
A06 Drug ingredients and/or prescription compositions and their Chinese translations
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A07 Pharmaceutical production process and its Chinese translation
A08 Pharmaceutical quality standards and inspection methods and its Chinese translation
A09 Quality standards and inspection methods of raw materials for preparations and Its Chinese translation
A10 Quality standards and inspection methods for excipients used and their Chinese translation
A11 Quality standards and inspection methods for packaging materials in direct contact with pharmaceuticals and their Chinese translation
A12 Quality inspection reports for three batches of drugs
A13 Stability test data
Al4 Main pharmacodynamic test data
A15 General pharmacological research Data
Al6 acute toxicity test data
Al7 long-term toxicity test data
Al8 mutagenicity test data
A19 reproductive toxicity test data< /p>
A20 Carcinogenicity Test Data
A21 Dependence Test Data
A22 Animal Pharmacokinetic Data
A23 Drug Clinical Research Data
p>A24 English instructions (or original instructions) approved by the national drug regulatory authority of the country of drug production and its Chinese translation
A25 Samples of drug packaging, labels and instructions
A26 Samples of drugs and other information
Items of application materials for applying for renewal of the "Import Drug Registration Certificate"
H01 The national drug authority of the drug producing country approves drug registration, production, sales, export and Certification documents, notarized documents and Chinese translations of the manufacturing plant's compliance with Good Manufacturing Practices (GMP)
H02 Authorization documents, notarized documents and Chinese translations of foreign pharmaceutical manufacturers authorizing Chinese agents to declare on their behalf, Copy of the industrial and commercial license of the Chinese agent; copy of the registration certificate of the foreign pharmaceutical manufacturer’s permanent representative office in China
H03 Current drug prescription composition and its Chinese translation
H04 Current drug production process and Its Chinese translation
H05 Current quality standards and inspection methods for pharmaceuticals and their Chinese translation
H06 Current quality standards and inspection methods for pharmaceutical raw materials and their Chinese translation
< p>H07 Current quality standards and inspection methods for excipients used and their Chinese translationH08 Current quality standards and inspection methods for packaging materials that are in direct contact with drugs and their Chinese translation
H09 Recent Quality inspection reports for three batches of drugs
Hl0 Current English instructions (or original instructions) approved by the national drug regulatory authority of the country of drug production and its Chinese translation