EMA Includes Broader Range of PSURs in Risk-Benefit Assessments

The new assessment plan – announced last week​ – will eventually see the European drug watchdog consider all periodic safety update reports (PSUR) for active ingredients irrespective of whether the drug containing them is authorised centrally or at national level.

Previously, the European Medicines Agency (EMA) could only assess API PSURs for marketed drugs that had been approved through centralized European procedures. However, over the past few years the agency has been working to harmonize reviews across the European Economic Area under revised pharmacovigilance laws introduced in 2010.

As a result – since Monday this week – the agency has used PSURs for drugs approved at both national and European level to detect any changes to API risk-benefit profiles.

APIs found in pharmaceutical products that are only approved at national level​ will not be included in the single assessment process, although the EMA said that it intends to start considering such reports in reviews conducted ‘after 2013.’

Detailed PSUR reporting requirements were set out by the EMA in the EU reference dates and frequency of submission of PSURs – or ‘EURD list’​ – in October last year.

Impact​

The EMA told in-Pharmatechnologist.com that: "Overall there will be fewer submissions of PSURs in the EU but when they are submitted the documents will be more robust. The Commission’s 2008 legal proposal was accompanied  by an impact assessment that demonstrated resource savings for the industry from the proposals for PSURs.​

"The full benefit in terms of both efficiency gains and resources will only be fully realized after a few years of operation of the legislation​."

The organisation also said that it has not had any increase in its head count to support the implementation of the pharmacovigilance legislation adding that it will involve juggling priorities

"The legislation implementation has had to be delivered through process improvement and re-prioritisation. No payments are yet made to rapporteurs for PSUR assessments. A European Commission proposal for an amendment to the EMA fee regulation is awaited and this will drive the resources available in the future for PSUR management and assessment.​"