PSURPeriodic Safety Update Report
PSURPesticide Sales and Use Reporting (New York)
PSURPennsylvania State University Reactor
References in periodicals archive ?
The head of clinical pharmacology at another monitoring centre described that oftentimes the CDSCO had not reviewed the PSUR submitted by the pharmaceutical company so there was a lack of feedback or there was no time to track the post-marketing surveillance.
Companies were required to submit PSURs at specified intervals following approval of a drug.
Through the submission of PSURS and reporting of serious ADRs within a specified timeframe, companies were required to comply with the regulatory requirements for reporting ADRs to the national PV centres.
The Committee reviewed the PSURs for Oncept IL-2, Palladia, SevoFlo, Simparica and Zeleris, and concluded that no further action or changes to their product information were required.
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement.
PSURs are reports that evaluate the benefit-risk balance of a medicine as evidence is gathered in clinical use.
Before that, PSURs for medicines containing the same active substance or the same combinations were submitted for assessment by their respective marketing authorisation holders to different national competent authorities at different times.
The PSURs submitted by marketing authorisation holders are assessed by EMAs Pharmacovigilance Risk Assessment Committee (PRAC) together with a leading assessor from one nominated national authority for medicines regulation, the so-called lead Member State.
In a business making drugs based on, for example, acetylsalicylic acid, a product that has been on the market for well over 100 years, the chances are there is often no new knowledge to be gained from PSURs (Periodic Safety Update Reports) and single case handling, yet the dogged reporting and analysis still has to take place in order to maintain compliance.
Volume 9a states that drug companies may now collectively submit their PSURs, for example for generic products, rather than individually.
The Committee reviewed the PSURs for BTVPUR, BTVPUR Alsap 1, Cardalis, Convenia, Equilis Prequenza, Equilis Prequenza Te, Eryseng, Eryseng Parvo, Innovax ILT, Onsior, Porcilis ColiClos, Poulvac E.
PSUSAs are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU).