The regulatory requirements, in most countries make it obligatory to submit the PSUR for all Registered Products and not merely for Marketed Products. Safety Reports are designated as Periodic Safety Update Reports (PSUR), Addendum Reports (AR) and Summary Bridging Reports (SBR), depending on the periodicity of the submissions as well as the contents of the document. Safety Reports are essential documents, which are crucial to the global process of assessment of Drug Safety. While preparation of these reports is a mammoth task, appropriate approval and authorisation, distribution and monitoring of timely compliance as well as archiving of prepared submissions is inclusive in the process. Safety reports play a key role in the assessment of drug safety.
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