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EMA Highlights: EU launches central repository for drug safety reports

Written by | 9 Feb 2015 | All Medical News

by Gary Finnegan: An electronic repository for periodic safety update reports (PSURs) and their assessment reports has been launched by the European Medicines Agency (EMA).

The central platform was created in accordance with European pharmacovigilance legislation and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.

Pharmaceutical companies are required to evaluate the benefits and risks of authorised medicines and to summarise the results in a PSUR submitted to EMA. The Agency uses this information to determine whether new risks are identified for a medicine or the balance of benefits and risks of a medicine has changed and take appropriate action.

For medicines containing the same active substances or combinations of active substances, the Agency assesses the related PSURs together even if the specific substances are contained in different medicines and authorised in more than one EU country.

The new central repository stores PSURs, PSUR assessment reports, comments, and final outcomes, and gives secure access to authorised users from national competent authorities in EU countries, EMA, Agency committees, and the European Commission.

It will ensure that all people involved in benefit risk assessments of medicines have timely access to all relevant documents in one location. The repository also facilitates the electronic submission of PSURs by pharmaceutical industry.

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