The State Food and Drug Administration just released this document

On June 25, the State Food and Drug Administration issued a notice saying that in order to implement the requirements of the notice on issues related to the review and approval of clinically urgently needed overseas new drugs (No 79, 2018), accelerate the review and approval of clinically urgently needed overseas new drugs, it has organized and formulated the requirements for materials and samples (chemicals) for the reexamination and test of clinically urgently needed overseas new drug standards and the reexamination of clinically urgently needed overseas new drug standards Data and sample requirements for nuclear inspection (biological products) It is mentioned in the announcement that for the varieties listed in the list of clinically urgent overseas new drugs published by the drug evaluation center of the State Food and drug administration, the applicant shall submit relevant materials and samples for drug standard review and inspection to CFDA at the same time when applying for drug listing according to the requirements of the announcement The circular shall be implemented as of the date of promulgation Appendix 1 Data and sample requirements for the reexamination and inspection of overseas new drug standards urgently needed in clinical (chemicals) 1 Data requirements 1 Acceptance notice (copy) and inspection notice (original) issued by the national drug review agency and application form for registration of imported drugs (copy) filled in by the applicant 2 Chinese and English drug standards, inspection methods and methodological validation data of relevant inspection methods (including validation data of sterility and microbial limit inspection in accordance with the requirements of current Chinese Pharmacopoeia), drug standards and drafting instructions in accordance with the format of current Chinese Pharmacopoeia 3 Prescription and production process 4 Factory inspection report 5 Inspection report and relevant research data of reference materials (reference materials) involved in the standard 6 Standards and inspection methods of APIs and excipients in the declared preparations 7 Stability test data 8 Other necessary pharmaceutical research data The above information shall be provided in both paper version (stamped with the official seal of the applicant) and corresponding electronic version 2、 Requirements for samples, reference materials and experimental materials (I) samples 1 The samples shall be of commercial production scale, and the relevant information of samples (such as origin, packaging materials, etc.) shall be consistent with the information provided when applying for listing registration 2 The API shall select the packaging materials consistent with the imported packaging materials under appropriate conditions in advance for sub packaging and sample delivery, and try to select small packaging specifications to avoid sample pollution and ensure the conduct of various experiments 3 If the samples are of various specifications, each specification shall be three batches of samples, and the quantity of each batch of samples shall be three times of the total inspection quantity The validity period of the samples shall not be less than 6 months from the end of validity period If the concentration of liquid preparation and semi-solid preparation (such as ointment, cream, etc.) is the same and there are many specifications, three batches of samples with one specification and at least one batch of samples with other specifications can be determined for inspection according to the specific situation 4 If the standard involves microbial limit, sterility and other items, in order to avoid sample pollution, the independent packaging sample used for the test shall also be provided （2） The reference materials (reference materials or standards) involved in the inspection and methodology verification shall be three times of the amount used for the standard recheck inspection and the first import inspection （3） The experimental materials exceed the experimental materials used in the Chinese Pharmacopoeia, including auxiliary materials, special chromatographic columns, special reagents, experimental supplies, etc Attachment 2 Data and sample requirements (biological products) for the reexamination and inspection of overseas new drug standards urgently needed in clinic 1 Data requirements 1 Acceptance notice (copy) and inspection notice (original) issued by the national drug review agency and application form for registration of imported drugs (copy) filled in by the applicant 2 Chinese and English drug standards, inspection methods and methodological validation data of relevant inspection methods (including validation data of sterility and microbial limit inspection in accordance with the requirements of the current Chinese Pharmacopoeia) for the delivery and shelf life of the original solution and finished products; drug standards and drafting instructions in accordance with the format of the current Chinese Pharmacopoeia 3 Prescription and production process of original solution and finished product 4 Inspection report of original solution and finished product 5 Inspection report and relevant research data of reference materials (reference or reference) involved in the standard 6 Standards and inspection methods of APIs and excipients in the declared products 7 Stability test data 8 Other necessary pharmaceutical research data The above information shall be submitted in both paper version (stamped with the official seal of the applicant) and corresponding electronic version 2、 Requirements for samples, reference materials and experimental materials (I) samples 1 The samples shall be samples of commercial production scale, and the relevant information of inspection samples (such as origin, packaging materials, etc.) shall be consistent with the information provided when applying for listing registration 2 The original solution shall be selected with appropriate packaging materials in advance under appropriate conditions for sub packaging and sample delivery, so as to ensure that the packaging materials used do not affect product quality, and try to select small packaging specifications to avoid sample pollution and ensure the conduct of various experiments 3 If the samples are of various specifications, each specification shall be three batches of samples, and the quantity of each batch of samples shall be three times of the total inspection quantity The submission date of samples shall be no less than 6 months from the end of validity period If the concentration of the finished product is the same and there are multiple specifications, three batches of samples with the largest specification and at least one batch of samples with other specifications shall be provided for inspection 4 If the standard involves microbial limit, sterility and other items, in order to avoid sample pollution, the independent packaging sample used for the test shall also be provided （2） Reference materials provide three times the amount of reference materials (reference materials or reference materials) used for standard review and inspection, and should be packed as small as possible （3） The experimental materials exceed the experimental materials used in the standard of Chinese Pharmacopoeia, including auxiliary materials, special chromatographic columns, special reagents, cell lines for testing and bacterial species, experimental supplies, etc.