
PSUR Repository Becomes Mandatory in EU
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
The European Union’s (EU) PSUR repository becomes
According to EMA, PSURs must be submitted following a drug’s authorization. They provide evaluation of the benefit-risk balance of a drug and results of studies performed on the medication. PSURs will now be sent to a single recipient, which simplifies the process. The repository also ensures that NCAs and EMA each have secure and timely access to information.
The PSUR repository, which must be used by regulatory authorities and pharmaceutical companies in the EU, was introduced by EU pharmacovigilance legislation to facilitate the exchange of safety information. Guidance and training are available on the EMA eSubmission
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