It shouldn't be this way: Generic drug firms air frustration over EU risk management plans
This article was originally published in SRA
Executive Summary
Three years after the EU pharmacovigilance legislation came into force, generic drug companies are still struggling to comply with a mandatory provision under the law that requires them to prepare and submit risk management plans (RMPs) with their initial marketing authorization applications.
You may also be interested in...
EMA To Up Transparency On Drug Safety By Publishing Risk Management Plans In Full
Risk management plans are among the documents to which EU citizens, especially sponsors of generic medicines, most frequently request access. The European Medicines Agency has decided to publish these in full for new medicines rather than just publishing RMP summaries.
EMA Cites EU Data Protection Rules, HQ Relocation For 2020 Transparency Dip
Risk management plans submitted to the European Medicines Agency as part of marketing authorization dossiers were the most sought-after document type last year under the agency’s ‘access to documents’ policy.
EU Generic Industry Group Looks At Radical Options To Simplify Pharmacovigilance Tasks
From looking at ways to reduce the number of audits undertaken by companies to fulfil their pharmacovigilance obligations to calling for harmonized assessment of risk management plans, the EU generics and biosimilars industry group Medicines for Europe says it is ready to explore some radical proposals to simplify the current pharmacovigilance requirements.