NMPA issues the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings

To implement the requirements in the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical Settings (No. 79  of  2018) and expedite the  review & approval of overseas new marketed drugs urgently needed in clinical settings, NMPA organized the formulation of the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Chemicals) and the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Biologicals), which were issued on June 25, 2019. For any variety included in the list of Overseas New Drugs Urgently Needed in Clinical Settings promulgated by CDE of NMPA, the applicant shall, while applying for marketing, submit the relevant dossiers and samples for drug standard verification and inspection to the National Institutes for Food and Drug Control in accordance with the requirements of this Announcement.

This Announcement shall enter into effect as the date of promulgation.

Annex 1 Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Chemicals)

I.Requirements for dossiers

1.The Notice of Acceptance (Photocopies) and the Notice of Inspection (Original) issued by Center for Drug Evaluation, and the Application Form for Registration of Imported Drugs (Photocopies) filled in by the applicant.

2.Drug substance release or shelf-life specifications in Chinese and English versions, test methods and relevant method validation data (including validation data for sterility and microbial limit tests in accordance with the current Chinese Pharmacopoeia), specifications and drafting instructions collated as per the format of the current Chinese Pharmacopoeia.

3.Prescription and production process.

4.Factory inspection report.

5.Test report and related research materials of standard substance (reference substance) involved in the specification.

6.Specifications, test methods and other dossiers for APIs and excipients in the preparations applied.

7.Stability test data.

8.Other necessary pharmaceutical research materials.

The above information must be provided with both a paper version (with the official seal of the applicant) and corresponding electronic version.

II.Requirements for samples, standard substances and test materials

(I)Samples

1.The sample should be of commercial production scale, and the sample- related information (such as place of origin, packaging materials) should

be consistent with that provided when applying for marketing registration.

2.The sample APIs should be sub- packaged in advance, under proper conditions, with packaging materials consistent with those to be imported as applied. Small packaging specifications should be selected as far as possible to avoid sample contamination and ensure the proper progress of each test.

3.For a sample with various strengths, three batches of samples per strength, the sample size of each batch shall triple that of the full test. The shelf life of all samples should be  no  less than 6 months near expiry date. For liquid preparations, semi-solid preparations (such as ointments, creams) with identical concentration of the main drug and various strengths, three batches of the maximum strength and at least one batch of other strengths can be selected for test, as appropriate.

4.For specifications involving microbial limits, sterility and other test items, to avoid sample contamination, the individually packaged samples for this test shall also be provided.

(II)Standard substances

The standard substance (reference or standard product) involved in the test and method validation shall  be provided in triplication to satisfy the standard verification and inspection and initial import inspection.

(III)Test materials

Test materials beyond those used in the current Chinese Pharmacopoeia, including excipients i n preparations, special chromatographic columns, special reagents, and laboratory supplies, etc.

Annex 2 Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in  Clinical  Settings

(Biologicals)

I.Requirements for dossiers

1.The Notice of Acceptance (Photocopies) and the Notice of Inspection (Original) issued by Center for Drug Evaluation, and the Application Form for Registration of Imported Drugs (Photocopies) filled in by the applicant.

2.Raw liquid and finished product release or shelf-life specifications in Chinese and English versions, test methods and relevant method validation data (including validation data for sterility and microbial limit tests in accordance with the current Chinese Pharmacopoeia), specifications and drafting instructions collated as per the format of the current Chinese Pharmacopoeia.

3.Prescription and production process of raw liquid and finished product.

4.Inspection report of raw liquid and finished product.

5.Test report and related research materials of standard substance (reference substance or product) involved in the specification.

6.Specifications, test methods and other dossiers for APIs and excipients in the products applied.

7.Stability test data.

8.Other necessary pharmaceutical research materials.

The above information must be provided with both a paper version (with the official seal of  the  applicant) and corresponding electronic version.

II.Requirements for samples, standard substances and test materials

(I)Samples

1.The sample should be of commercial production scale, and the sample- related information (such as place of origin, packaging materials) should be consistent with that provided when applying for marketing registration.

2.The raw liquid should be sub-packaged in advance, under proper conditions, with packaging materials consistent with those to be imported as applied. Small packaging specifications should be selected as far as possible to avoid sample contamination and ensure the proper progress of each test.

3.For a sample with various strengths, three batches of samples per strength, the sample size of each batch shall triple that of the full test. The shelf life of all samples should be  no  less than 6 months near expiry date. For liquid preparations, semi-solid preparations (such as ointments, creams) with identical concentration of the main drug and various strengths, three batches of the maximum strength and at least one batch of other strengths can be selected for test, as appropriate.

4.For specifications involving microbial limits, sterility and other test items, to avoid sample contamination, the individually packaged samples for this test shall also be provided.

(II)Standard substances

Standard substance (reference substance or product) shall have a sample size tripling that of the test amount for standard verification and inspection, and should be packaged in small size as much as possible.

(III)Test materials

Test materials beyond those used in the current Chinese Pharmacopoeia, including excipients i n preparations, special chromatographic columns, special reagents, cell strains for assay, bacterial strains, and laboratory supplies, etc.