Guidelines for the approval of packaging materials and containers for direct contact with pharmaceuticals

ã€Chinese Packaging Network Newsã€‘ This guideline is applicable to the application and processing of the approval of packaging materials and containers for direct contact with drugs.

Second, project information

(1) Project Name: Approval of Packaging Materials and Containers Directly in Contact with Drugs

(B) Approval Category: Administrative Licensing

(3) Project Code: 30004

Third, the basis for processing

"The People's Republic of China Drug Administration Law", "The People's Republic of China Drug Administration Act Implementation Regulations," and "Direct Contact Drugs Packaging Materials and Container Management Measures."

Fourth, acceptance agencies

State Food and Drug Administration Drug Review Center

Fifth, the decision agency

State Food and Drug Administration

Sixth, the number of approvals

No limit

VII. Working Conditions

Applicant Conditions: Overseas applicants should be legally registered overseas pharmaceutical packaging material manufacturers.

VIII. Application Materials

(I) Examination and approval of packaging materials and containers for direct contact with pharmaceuticals (including Hong Kong, Macao and Taiwan)

1. Application Materials Directory

(1) Application Form for Registration Certificate of Imported Pharmaceutical Packaging Materials and Containers:

(2) Producers' legal production qualification certificates, notarized documents and their Chinese translations;

(3) Declared product manufacturers entrust authorized agencies in China to file the authorized documents, notarized documents and their Chinese translations. Business licenses of agencies in China or "Registration certificates of permanent representative offices of foreign companies in China" that apply to domestic manufacturers' offices in China;

(4) Summary of production, sales and application of declared products in foreign countries and the reasons for applying for special instructions for registration in China;

(5) Three batches of declared product quality inspection reports issued by drug and packaging inspection agencies set up or determined by the State Food and Drug Administration;

(6) Cleanroom (area) cleanliness inspection report and three batches of product self-inspection report;

(7) The formula of the declared product;

(8) The production process of the declared product and the description of the main production and inspection equipment;

(9) Quality standards for declared products;

(10) Research data on stability tests (drug compatibility tests) conducted in conjunction with drugs packaged in declared products;

(11) Apply for the floor plan of the product production plant area and clean room (area).

2. General requirements for filing data:

(1) The first page of filing data is the list of filing data items, and the application data items in the list are arranged in the order specified in Attachment 3 of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs (Order No. 13 of the State Food and Drug Administration). On the cover of each item, indicate the name of the medicine package, the item number of the item, the name of the item, the contact name of the applicant organization, telephone number, and address.

(2) The application materials should be printed or copied on A4 paper. The contents are clear and must not be altered. The data should be complete and standardized, and the data should be true and reliable.

(3) Information is put into the portfolio according to the package, and the cover of the portfolio is indicated: application classification, registration classification, packaging material name, X bag X bag belonging to X bag, original/copy, contact person, contact phone, Application for registration agency name.

(4) Submit 2 sets of complete application materials (1 set as original and 1 set as copy), 3 copies of application form (2 copies of original data, and 1 copy of copy information).

(5) "Application Form for Registration of Medicine Packaging Materials": Download the "Drug Registration Application Form Proposal Procedure" from the website of the State Food and Drug Administration (SFDA), fill in the form as required, and print and save it.

(6) The electronic version of the application form should be sent to the applicant when mailing or submitting application materials.

(7) The data check code of the electronic application form and the paper application form should be the same.

(8) All application materials should be in Chinese and attached with English. Other documents can be attached for reference. The Chinese translation should be consistent with the original text.

3. Specific requirements for filing data:

(1) "Application Form for Registration of Medicine Packaging Materials": Fill in the application form according to the instructions for completing the form. All applicants should sign and seal the application form (if any).

(2) Proof documents:

1) Producers' legal production qualification documents, notarized documents and their Chinese translations

The applicant shall submit a copy of the certification documents (according to China's industrial and commercial business license, production license or registration certificate, etc.) of the country of origin of the government of the country that approved the production and operation of the pharmaceutical packaging materials, and the original notarial certificate issued by the notary public Chinese translation. If the government of the country of origin does not require the application of the above-mentioned special approval, it may be exempted from submitting this information.

2) Original letter of authorization from a foreign manufacturing company commissioned by an agency in China, the original certificate issued by the notary office of the host country, and a Chinese translation

3) A copy of the "Business License for Industry and Commerce" of an agency in China or a copy of the "Registration Certificate of a Permanent Representative of a Foreign Enterprise to China's Representative Office" of a foreign manufacturer's permanent office in China.

(3) Summary of production, sales and application of declared products in foreign countries and reasons for applying for special instructions in Chinese registration.

(4) Inspection report:

1) The three batches of declared product quality inspection reports issued by the drug and packaging inspection agency set up or determined by the State Food and Drug Administration shall be original and may be separately submitted after the technical review work begins.

2) The original cleanroom inspection report of the clean room (area) shall be submitted within one year of the reporting date.

3) The original self-inspection report of the three batches of declared products shall be submitted.

(5) Quality standards:

If the quality standards for the drug packaging materials provided are new drug packaging materials or corporate standards, drafting instructions for standards should also be provided.

(6) Other materials shall be sorted out in accordance with Annex 3 of the "Measures for the Administration of Packaging Materials and Containers Directly in Contact with Drugs" (Order No. 13 of the State Food and Drug Administration).

(II) Re-registration of packaging materials and containers that are directly in contact with pharmaceuticals (including Hong Kong, Macao and Taiwan)

1. Application Materials Directory

(1) Re-registration application form for drug packaging materials;

(2) The certificate of approval of the drug packaging material issued by the Bureau and the certificate of approval change;

(3) Producers' legal production qualification documents, notarized documents and their Chinese translations;

(4) The declaration product manufacturer commissions the authorized documents, notarized documents and Chinese translations filed by agencies in China. Business licenses of agencies in China or "Registration certificates of permanent representative offices of foreign companies in China" that apply to domestic manufacturers' offices in China;

(5) Three batches of declared product quality inspection reports issued by the drug and packaging inspection agency set up or confirmed by the State Food and Drug Administration;

(6) Cleanroom (area) cleanliness inspection report and three batches of product self-inspection report;

(7) the formula of the declared product;

(8) The production process of the declared product and the description of the main production and inspection equipment;

(9) Quality standards for declared products;

(10) The summary report on the sales and quality of the product in China within three years;

(11) Approval of the implementation of the work to be completed when the product is registered or re-registered.

2. General requirements for filing data:

(1) The first page of the application data is the list of application data items. The application data items in the list are arranged in the order specified in Annex 4 of the â€œMeasures for the Administration of Packaging Materials and Containers Directly in Contact with Drugsâ€ (Order No. 13 of the State Food and Drug Administration). On the cover of each item, indicate the name of the medicine package, the item number of the item, the name of the item, the contact name of the applicant organization, telephone number, and address.

(3) The information is put into the portfolio according to the set, and the cover of the portfolio is indicated: application classification, registration classification, name of the packaging material, the X-seat of the bag belongs to the X-bag, X-bags in each set, original/copy contacts, contact phone number, application Registered agency name.

(4) Submit 2 sets of complete application materials (1 set as original and 1 set as copy), 3 copies of application form (2 copies of original data, and 1 copy of copy information).

(5) "Application Form for Drug Packaging Material Re-registration": Download the "Drug Registration Application Form Proceedings Procedure" from the website of the State Food and Drug Administration (SFDA), fill it out as required and save it.

(6) The electronic version of the application form should be sent to the applicant when mailing or submitting application materials.

(7) The data check code of the electronic application form and the paper application form should be the same.

(8) All reporting materials should be in Chinese and attached with English. Other documents can be attached for reference. The Chinese translation should be consistent with the original text.

3. Specific requirements for filing data:

(1) "Application Form for Drug Packaging Material Re-registration": Fill in the application form according to the instructions for filling in the form. All applicants should sign and seal the application form (if any).

(2) Proof documents:

1) Copies of approval documents for approval of drug packaging materials issued by our bureau

2) Producers' legal production qualification documents, notarized documents and their Chinese translations

The applicant shall submit a copy of the certificate of approval for the production and operation of pharmaceutical packaging materials by the government of the country of origin (equivalent to the business license, production license or registration certificate of China, etc.), the original certificate issued by the notary office of the host country, and Chinese translation. If the government of the country of origin does not require the above-mentioned special approvals, it may be exempted from submitting such information after it is truthfully stated.

3) The original authorized documents that the foreign production factory commissioned the agency in China, the original certificate issued by the notary office of the host country, and the Chinese translation

4) A photocopy of the "Business License for Industry and Commerce" of an agency in China or a copy of the "Registration Certificate of a Permanent Representative of a Foreign Enterprise to a Chinese Representative Office" of a foreign-based manufacturing company's permanent office in China.

(3) Inspection report:

1) The three batches of declared product quality inspection reports issued by the drug and packaging inspection agency set up or confirmed by the State Food and Drug Administration shall be original, and may be separately submitted after the technical review work begins.

2) The original cleanroom inspection report of the clean room (area) shall be submitted within one year of the reporting date.

3) The original self-inspection report for three batches of declared products shall be submitted.

(4) Change:

1) If there is a change from the last registration, you should indicate the specific changes and indicate on the application form.

2) If the quality standard changes, the original quality standard, revised quality standard and revised description should be provided.

3) If there is a change in a foreign production plant, it should be stated on the application form.

4) If the agency changes, it should provide the authorization documents, notarized documents and Chinese translations that the imported pharmaceutical packaging material manufacturer authorized by the new Chinese agency. A copy of the business license of the new Chinese agency and the original agency agreed to waive the agency's supporting documents.

(5) Summary report:

It should include the annual sales in China, the drug manufacturers that use this product, and the catalogs of the drugs they are packaging, user evaluations, quality inspections, the drug packaging company's self-test qualification rate, quality accidents, and the government. Quality sampling, etc.

(6) Other materials shall be sorted out in accordance with Annex 4 of the â€œDirectory Measures for Packaging Materials and Containers Directly in Contact with Drugsâ€ (Order No. 13 of the State Food and Drug Administration).

(3) Examination of Supplementary Application of Packaging Materials and Containers for Direct Contact with Imports (including Hong Kong, Macao and Taiwan)

1. Application Materials Directory

(1) Supplementary application form for drug packaging materials;

(2) A copy of the approval document for drug packaging materials;

(3) The original quality inspection report after three batches of declared varieties issued by the inspection agency set up or confirmed by the State Food and Drug Administration;

(4) The original report on the cleanliness of the clean room (area) of the production site after the change made by the inspection agency set up or confirmed by the State Food and Drug Administration;

(5) The changed raw material source certification, the implementation of quality standards and inspection report of factory quality;

(6) The proof of the source of the modified auxiliary materials, the quality standards for implementation, and the basis for safe use;

(7) Comparative research data on production processes before and after the change;

(8) Changes in registration specifications and registration standards before and after the change;

(9) The original quality self-inspection report of the manufacturer after the three batches of declared varieties have been changed;

(10) The stability test study data (including the quality standards of the test drugs) that are jointly used by the changed packaged drugs;

(11) Plan of the production plant area and clean room (area) after the change;

(12) The competent authority of the country where the imported pharmaceutical packaging material manufacturer is located approves the relevant documents, notarized documents and Chinese translations of the application for changing the "company name" or "registration address";

(13) Authorized documents, notarized documents and Chinese translations submitted by new Chinese agencies authorized by the import drug packaging manufacturers. A copy of the business license of the new Chinese agency and the original agency agreed to waive the agency's supporting documents.

Note: The above information shall be submitted according to the â€œAnnex 5 Application Data Sheetâ€ of the â€œMeasures for the Management of Packaging Materials and Containers Directly in Contact with Drugsâ€ for different supplementary application items. In addition to submitting the above-mentioned required information, the supplementary application for importing pharmaceutical packaging materials must also submit the authorized documents, notarized documents and Chinese translations that the imported pharmaceutical packaging material manufacturer has authorized by the Chinese agency, and the copy of the business license of the Chinese agency or A copy of the â€œRegistration Certificate of a Permanent Representative of a Foreign Enterprise to a Representative Office in Chinaâ€ issued by the permanent representative office in China of the declared variety production enterprise.

2. General requirements for filing data:

(1) The first page of the application materials is the list of application data items. The application data items in the catalogue are arranged in the order stipulated in Annex V of the Measures for the Administration of Packaging Materials and Containers Directly Contacted with Drugs (Order No. 13 of the State Food and Drug Administration). On the cover of each item, indicate the name of the medicine package, the item number of the item, the name of the item, the contact name of the applicant organization, telephone number, and address.

(2) The application materials should be printed or copied on A4 paper. The content is clear and must not be altered. The data should be complete and standardized, and the data should be true and reliable.

(4) Submit 2 sets of complete application materials (1 set as original and 1 set as copy), 3 copies of application form (2 copies of original data, and 1 copy of copy information).

(5) "Supplementary Materials for Drug Packaging Materials Application Form": Download the "Drug Registration Application Form Proceedings Procedure" from the website of the State Food and Drug Administration, fill in the required information, and print and save it.

(6) The electronic version of the application form should be sent to the applicant when mailing or submitting application materials.

(7) The data check code of the electronic application form and the paper application form should be the same.

(8) All reporting materials should be in Chinese and attached with English. Other materials can be attached for reference. The Chinese translation should be consistent with the original text.

3. Specific requirements for filing data:

(1) "Complete Application Form for Drug Packaging Materials": Fill in the application form in accordance with the instructions for filling in the form. All applicants should sign and seal the application form (if any).

(2) Proof documents:

1) Copies of approval documents for approval of drug packaging materials issued by our bureau

2) The competent authority of the country where the importer of pharmaceutical packaging materials is authorized approves the relevant documents, notarized documents and Chinese translations of his application for changing the "company name" or "registered address".

The applicant may submit a copy of the certificate of approval of the production and operation of the pharmaceutical packaging material of the country of origin of the country of origin (equivalent to the business license, production license or registration certificate of China, etc.), the original certificate issued by the notary office of the host country, and Chinese translation. If the government of the country of origin does not require the application of the above-mentioned special approval, it may be exempted from submitting this information.

3) The original authorized documents that the foreign production factory commissioned the agency agency in China, the original certificate issued by the notary office of the host country, and the Chinese translation

(3) Other materials are sorted out in accordance with Annex 5 of â€œDirectory Measures for Packaging Materials and Containers Directly in Contact with Drugsâ€ (Order No. 13 of the State Food and Drug Administration).

(D) Submitting Application Materials

Applicants can submit materials through window submission, mailing, etc.

Nine, apply for receiving

(I) Receiving method

1. Window reception;

2. Receive by mail.

Receiving Department: Administrative Reception Hall of the State Food and Drug Administration

Reception address: 1/F, 3/F, Dacheng Plaza, No. 28, Xuanwumen West Street, Xicheng District, Beijing

Postal Code: 100053

Contact Tel: 010-88331866

3. E-mail:

(B) External office hours: 9:00-11:30 in the morning, 13:00-16:00 in the afternoon

Ten, handle the basic process

XI. How to apply

(I) Examination and approval of packaging materials and containers that are in direct contact with drugs

1. Acceptance:

According to Article 8 of the Guidelines, the applicant shall submit an application to the Administrative Reception Service Hall of the State Food and Drug Administration, and the application personnel shall conduct formal examination of the application materials. If an application does not require an administrative license in accordance with the law, it shall immediately notify the applicant that it will not be accepted; if the application does not fall within the scope of the authority of the administrative authority according to law, the decision shall be promptly made inadmissible, and the applicant shall be notified of the application to the relevant administrative authority; Correcting mistakes on the spot, allowing applicants to make corrections on the spot; if the application materials are incomplete or do not comply with the statutory form, the applicant shall notify the applicant of the full contents of the amendments on the spot or within five days. From the day the application is accepted; the application matters are within the scope of the authority of this administrative agency; if the application materials are complete and in compliance with the statutory form, or the applicant submits all the application materials for correction according to the requirements of this administrative agency, the application for administrative license shall be accepted.

2. Drug packaging material registration inspection:

The applicant submitted three consecutive batches of samples by inspection and notification to the drug packaging material inspection agency set up or determined by the one-way State Food and Drug Administration. After receiving the registration inspection notice and sample, the pharmaceutical packaging inspection agency shall carry out inspection on the sample within 60 days, issue an inspection report and submit an opinion to the State Food and Drug Administration. The State Food and Drug Administration can, according to the needs of the work, conduct an on-site assessment of the development of imported pharmaceutical packaging materials and production conditions, and collect samples.

3. Technical review:

After receiving the inspection report and opinions, the State Food and Drug Administration shall organize and complete the technical review within 90 days. If the applicant needs additional information, the State Food and Drug Administration shall issue a supplementary information notice and notify the applicant once and for all that it needs to be supplemented. For the full content, the applicant shall complete the supplementary information in a one-time manner in accordance with the notice requirements within 4 months, failing to withdraw the supplementary materials within the prescribed time limit.

4. Administrative license decision:

The State Food and Drug Administration shall complete the examination and approval within 20 days after the completion of the technical review. If a decision cannot be made within 20 days, it may be extended by 10 days with the approval of the head of the Office. In accordance with the regulations, the "Imported Pharmaceutical Packaging Materials Registration Certificate" is issued; if it does not meet the requirements, a "Notification of Approval Opinions" is issued.

5. Delivery:

Within 10 days from the date of the administrative license decision, the acceptance and reporting center will send the administrative license decision to the applicant.

6. Review:

If the applicant disagrees with the disapproval decision, it may submit a review to the State Food and Drug Administration within 10 days after receiving the approval decision. The content of the review is limited to the original application, original submissions, and samples.

After receiving the application for review, the State Food and Drug Administration shall make a retrial decision within 50 days. If it is decided to cancel the original decision on disapproval, it shall issue the corresponding certificate of approval for the drug packaging material; if it is decided to maintain the original decision, the State Food and Drug Administration will no longer accept the application for re-examination.

(b) Re-registration of packaging materials and containers that come into direct contact with drugs

1. Acceptance:

Same as the above method of acceptance.

2. Drug packaging material registration inspection:

Same as above inspection method.

3. Technical review:

After receiving the inspection report and opinions, the State Food and Drug Administration shall organize and complete the technical review within 50 days. If the applicant needs additional information, the State Food and Drug Administration shall issue a supplementary information notice and notify the applicant once and for all that it needs to be supplemented. For the full content, the applicant shall complete the supplementary information in a one-time manner in accordance with the notice requirements within 4 months, failing to withdraw the supplementary materials within the prescribed time limit.

4. Administrative license decision:

Same as above, permission decision method

5. Delivery:

Same as the above matters served.

6. Review:

Same as above review method.

(3) Review of application for packaging materials and containers for direct contact with drugs

1. Acceptance:

Same as the above method of acceptance.

2. Technical review:

After the acceptance, if the State Food and Drug Administration considers it necessary to conduct a technical review, it organizes the completion of the technical review within 40 days. If the applicant needs additional information, the State Food and Drug Administration will issue a supplementary information notice and notify the applicant once that it needs to be supplemented. The applicant shall, within 4 months, complete the supplementary materials at one time according to the notification requirements, and fail to submit the supplementary materials within the specified time limit for review.

3. Administrative license decision: The State Food and Drug Administration shall complete the examination and approval within 20 days after completing the technical review. In the form of â€œApplication for Supplementary Materials for Pharmaceutical Packaging Materialsâ€, it is to be decided whether to agree; the decision of disagreement should explain the reasons; if it is necessary to renew the â€œRegistration of Pharmaceutical Packaging Materialsâ€ or the â€œRegistration of Imported Pharmaceutical Packaging Materials,â€ after recertification , The original license was announced and cancelled. (Note: The State Food and Drug Administration will complete the examination and approval within 20 days after the completion of the technical review. If approval cannot be completed within 20 days, it may be extended by 10 days with the approval of the head of the Office.)

4. Delivery:

Same as the above matters served.

5. Review:

Same as above review method.

XII. Approval time limit

1. Acceptance: 5 working days;

2. Administrative license decision: 20 working days (excluding the time required for registration inspections, technical reviews, and applicants' supplemental data and supplementary material review). If it is not possible to make a decision within 20 working days, it may be extended by 10 working days with the approval of the head of the General Administration of Administration.

XIII. Basis for and approval of fees and standards

There is no provision at this time.

XIV. Approval result

(1) The "Imported Drug Packaging Material Registration Certificate" is valid for 5 years. The "Application for Supplementary Materials for Pharmaceutical Packaging Materials" or the "Renewal of Imported Pharmaceutical Packaging Materials Registration Certificate" has the same validity as the original certificate; the validity of the registration certificate expires and needs to be continued. In case of import, the applicant shall apply for re-registration six months before the expiry of the validity period. After clinical trials of drugs are approved, they should be implemented within 3 years. If it is not implemented within the time limit, the original approval document will be abolished on its own; if clinical trials are still required, it shall be re-applied.

(B) Licensed annual review or annual inspection: none

15. Result delivery

Within 10 working days from the date of the decision on approval, the Administrative Bureau's Administrative Affairs Acceptance Service and Complaints and Reporting Center will send an administrative license decision to the applicant.

XVI. Rights and Obligations of Applicants

(1) According to the Administrative Licensing Law of the People's Republic of China, the applicant has the following rights according to law:

1. Equal rights to obtain administrative licenses according to law;

2. Implement administrative licenses for administrative agencies and enjoy the rights of statement and defense;

3. Apply for administrative reconsideration or file an administrative lawsuit in accordance with law;

4. If the lawful rights and interests are damaged due to administrative agencies' illegal implementation of administrative licenses, they have the right to demand compensation in accordance with the law.

(2) According to Article 155 and Article 156 of the "Administrative Measures for Registration of Drugs" (Order No. 28), the applicant shall enjoy the following rights according to law:

1. The drug regulatory department shall, in accordance with the law, make a written decision rejecting or disapproving, and shall explain the reasons and inform the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit according to law.

2. If the applicant disagrees with the disapproval decision made by the State Food and Drug Administration, he may complete the Drug Registration Review Application Form within 60 days from the date of receipt of the notification of disapproval and submit it to the State Food and Drug Administration. The Office submitted a review application and explained the reason for the review. The content of the review is limited to the original application and the original application.

(3) According to the Administrative Licensing Law of the People's Republic of China, the applicant fulfills the following obligations in accordance with law:

1. Be responsible for the authenticity of the substantive content of the application materials;

2. To carry out activities to obtain administrative licenses according to law;

3. Truthfully provide relevant information and materials to the administrative agency responsible for supervision and inspection.

(4) The applicant shall perform the corresponding obligations under the "Drug Administration Law", "Regulations for the Implementation of the Drug Administration Law," and "Administrative Measures for the Registration of Drugs".

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