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Documents, samples, reference standards and special laboratory material requirement for Registration



A.       Documents Requirement

1.         Documents issued by authorities

1.1      Sampling record (for drug manufactured in China)

1.2      Import Custom Declaration (for drug manufactured in China)

1.3      Origin Registration Inspection Notice or Deficiency Letter (not applicable for Pre-Registration Inspection).

2.         CTD Module 2 and Module 3.


B.       Specification written according to Chinese Pharmacopeia format and Justification of Specification

1.         Certificate of Analysis at release according to exhibit specification

2.         COAs and related study for reference standards that provided along with the samples

3.         Other necessary quality study dossier.

4.         Both documents for API and FDF should be provided if this API is applied to market along with the FDF.

5.         Approved drug specification should be provided if the post-marketing change inspection is applied.


Above documents should be provided both hard copy (with applicant stamp) and soft copy. Documents both in English and Chinese should be provided for drugs manufactured abroad. 


C.        Samples, Reference Standards and Special Experimental Apparatus

A.         Samples

(a)      Samples must be taken from commercial batches. Related information of sample (Manufacturing location, primary packaging, etc.) must be the same as the market authorization application.


(b)      Sample packaging must be intact with labels. Signatures or chops must be clear and identifiable. Labels must be the same as the relevant information in application. For imported drugs that are launched in overseas, commercial packaging is required.


(c)      For samples with multiple strengths, 3 batches of samples should be provided for each strength with amount for each batch 3 times of the amount for a complete analysis. Sample remaining expiry period must be at least 2 registration inspection cycles. If sample analysis and specification verification are performed simultaneously, samples must be valid at least 180 working days. If only sample analysis is required, samples must be valid at least 120 working days. For liquid formulations, semi solid formulations (ointment, cream, etc..) with same formulation but different strength, 3 batches of sample for one strength and 1 batch of sample for other strength could be provided for sample analysis.


(d)      For APIs, packaging materials must be the same as the ones in the application. Samples must be packed in smallest packages as possible. In order to prevent contamination and ensure the analysis is performed seamlessly.  


(e)      Specifications which cover tests items like microbial limits, sterility, etc, independent packaging for the individual test is preferred to prevent contamination.


B.          Reference Standards

Reference standards for inspection and method validation is required. Amount must be 3 times the amount for complete analysis. Requirements on expiry date for reference standards are the same as the ones on samples.


C.         Special experimental apparatus

For special experimental apparatus that are not in the current CP standards and difficult to obtain, including the required special columns , special reagents, etc, provision of these materials are necessary with essential instruction manual.