EMA Launches Add'l Safety Reporting for APIs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-06-2015 15:36


he European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports (PSURs) for active substances contained only in nationally authorized medicines. This initiative aims to support the harmonized implementation of safety measures for medicines with the same active substance across European Union (EU) member states.

All pharmaceutical companies holding marketing authorizations for medicines at national level are advised to regularly monitor the published information to check for outcomes relevant to their products.

PSURs are reports providing a regular evaluation of the benefit-risk balance of a medicine following authorization, which marketing-authorization holders submit at regular intervals to the competent medicines regulatory authority in the EU as long as a medicine is available on the market. A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances.

n the single assessment of nationally authorized products, a lead member state is appointed to assess whether new risks have been identified or the balance of benefits and risks of a medicine has changed. The assessment is reviewed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Based on the results, it decides if any action is needed to protect the public from any risks identified or if further investigations need to be carried out. The need for such action is confirmed by the Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh). The single assessment of PSURs for medicines with the same active substance aims to harmonize and strengthen the monitoring of the benefits and risks of all authorized medicines across the EU and is a deliverable of the 2010 pharmacovigilance legislation. In addition, the EMA already publishes the outcomes of PSURs for centrally authorized medicines.

To support member states and pharmaceutical companies to implement the outcomes of the assessments, EMA is now publishing the results of these procedures together with the lists of medicines concerned. Furthermore, when the procedure leads to a variation of marketing authorizations, a whole set of information materials is published in all official EU languages: the scientific conclusions, a timetable for implementation of the variation, and where amendments to the product information are required, the wording of the product information.

When a PSUR single assessment procedure leads to a variation of the marketing authorization, marketing-authorization holders for products containing the active substance(s) concerned should submit a variation to the relevant national competent authority to align their marketing authorization with the single assessment outcome (this includes generic medicines or medicines authorized on the basis of well-established use).

Source: European Medicines Agency


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