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Regarding imported drug application in China, what kind of certification documents are required  as drug marketing proof in other countries?

 Drug marketing certification documents include drug marketing authorization (MA) and Good Manufacturing Practice (GMP) certificate issued by the competent authority of the country or region where the drug is manufactured. If the drug has not been marketed in the country of manufacturing, the MA issued by the competent authority of the country or region of the MA holder’s headquarters can also be accepted. These documents shall be prepared in compliance with the model Certificate of Pharmaceutical Product (CPP) recommended by the World Health Organization (WHO).  

  Is foreign clinical data acceptable by China CDE for drug application?

 According to the Technical Guidelines for Acceptance of Foreign Clinical Data of Drugs (NMPA [2018] Decree No.52), China CDE can accept the foreign clinical data of new drug clinical trials and generic bioequivalence studies under the condition that the authenticity, completeness, accuracy and traceability of the data can be verified by the applicant and meet the requirements for drug registration. Based on the quality of the data, they can be fully accepted, partially accepted or  rejected.

 Is it mandatory that pilot samples should be produced by a GMP certified manufacturer?

 A GMP certificate is not required for the manufacturer, however, the production of pilot samples shall meet the GMP requirements.

 For how long shall a stability test be conducted to meet the requirement for a generic drug application?

 According to the Announcement on Adjusting Dossier Requirements for Long-term Stability Test of Chemical Generic Drugs (NMPA [2018] Decree No.82), when applying for the marketing authorization or the quality and efficacy consistency evaluation of a chemical generic drug, the product dossier shall include the data of a long-term stability test conducted for 6 months on three or more registration batches which are produced under the required scale.

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