EMA updates guidance on single assessment safety reports
This article was originally published in SRA
The European Medicines Agency has issued updated guidance to help drug companies submit periodic safety update reports (PSURs) for nationally authorized medicines that are subject to a single EU assessment1,2.
The EMA explains that marketing authorization holders of nationally authorized medicines that are subject to a PSUR single assessment must submit the PSURs to all the EU member states where their medicine is authorized and to the EMA. The guidance applies to medicines for which the frequency and dates of submission of the PSUR have been established in the list of EU reference dates (EURDs)3 and to drugs with data lock points falling on or after 1 September.
The updated procedural guidance clarifies how and to whom PSURs should be submitted. For nationally authorized medicines containing substances or a combination of active substances for which no single-assessment procedure has been established in the EURD list, the assessment of the PSUR will remain at national level. As of 26 August, marketing-authorization holders have had to pay a fee for assessment of PSURs.
The concept of single EU assessment of PSURs was introduced by the EU pharmacovigilance legislation to harmonize and strengthen the review of the benefits and risks of all medicines across the region. Procedures for single EU assessment of PSURs involving a combination of centrally authorized medicines and nationally authorized medicines have been in place since April 20134.
References
1. EMA press release, 1 September 2014, www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/08/news_detail_002160.jsp&mid=WC0b01ac058004d5c1
2. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev 43), September 2014, www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf
3. EMA finalises PSUR submission frequency under pharmacovigilance legislation, Scrip Regulatory Affairs, 3 October 2012
4. EMA offers guidance on submission of PSURs undergoing single assessment, Scrip Regulatory Affairs, 26 June 2013