Прошу совета где почитать, что это за документ?
Андрей (@andreimankovski), можно прочитать в руководстве ICH.
Company core data sheet (CCDS)
In accordance with ICH E2C(R1) recommendations, it is a common practice for MAHs to prepare their own CCDS, which includes sections relating to safety, indications, dosing, pharmacology, and other information concerning the medicinal product. The core safety information contained within the CCDS is referred to as the CCSI. A practical option is for MAHs to use the latest CCDS in effect at the end of the reporting interval as the reference product information for both the risk sections of the PBRER as well as the main approved indications for which benefit is evaluated. When the CCDS for a medicinal product does not contain information on approved indications, the MAH should clearly specify which document is used as the reference information for the approved indications in the PBRER.
У нас на фирме вообще по-тихому SmPC под это дело подкладывают и все проходит ?
