PSUR Repository Becomes Mandatory in EU

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Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

The European Union’s (EU) PSUR repository becomes mandatory on June 13, 2016. The single, central platform for submitting periodic safety update reports (PSUR) was developed by the European Medicines Agency (EMA) in collaboration with EU member states. Marketing authorization holders are now required to use the repository as a single point for all submissions. PSURs should no longer be submitted to national competent authorities (NCAs).

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 website


Source: EMA