EMA PSUR database fit for purpose

By Gareth Macdonald contact

- Last updated on GMT

EMA PSUR database fit for purpose
EMA PSUR database fit for purpose

Related tags: European medicines agency, European union, European commission

Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.

The European Medicines Agency (EMA) announced that its central repository for periodic safety update reports (PSURs) for approved drug had been given the green light following an assessment last week, explaining that the database is set to go live on June 13 next year.

The centralised PSUR repository provides an important simplification for the industry allowing marketing authorisation holders to upload the PSURs to one location.

The agency also said: "It also facilitates the assessment process by ensuring that NCAs in each member state, EMA and its scientific committees, and the European Commission have timely and secure access to all relevant documents​.”

The database – which has been in development since the 2012 revision​ of the European Union’s pharmacovigilance legislation – was launched in January​, however, drugmakers will not be required to use it until June next year.

Related topics: Markets & Regulations, Regulations

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