Post Authorisation Safety Study

What is Post Authorisation Safety Study?

Post Authorisation Safety Study definition and meaning on Health terms:
A post authorisation safety study is a study carried out after a medicine has been given a marketing authorisation. Its purpose is to obtain further safety information or to assess how well risk-management measures are working. The information from a post authorisation safety study is used in regulatory decision making. A post authorisation safety study might be a clinical trial or a non-interventional study, and can be created voluntarily by the MAH, or can be required by the regulator (

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