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EMA To Up Transparency On Drug Safety By Publishing Risk Management Plans In Full

 
• By Vibha Sharma

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.

White pills on leaflet about possible side effects and overdose
Companies are required to submit an RMP when applying for a marketing authorization • Source: Alamy

The European Medicines Agency has finalized an initiative to provide further transparency on how the safety risks of newly approved products are managed by drug sponsors throughout a product’s lifecycle.

It will result in the EMA publishing the full text of risk management plans (RMPs) in the European Public Assessment...

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