General considerations for initiating cause inspections during the drug evaluation process
The initiation of for-cause inspection in the drug review process is an important supplementary inspection method for drug regulatory authorities to discover problems that are not easily discovered during the initiation of routine registration inspection or the implementation of inspection of the R&D site under the"risk based"initiation of routine inspection mode.It plays an important role in drug regulation.The industry has always been concerned about the main risk factors and internal work procedures for initiating for-cause inspections in the drug review process.In order to better promote the industry and regulatory authorities to reach a basic consensus on the initiation of for-cause inspections during the drug review process,and to ensure the orderly and efficient implementation of drug evaluation,this article mainly introduces the regulatory basis,purpose,scope of situations,and internal work processes for initiating causal inspections in the drug review process based on the current work reality,and elaborates on some general considerations.
drug evaluationcause inspectiondrug registration inspectionrisk factors
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