The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorisation, two key tools in the European legislation to accelerate patients’ access to medicines that address unmet medical needs.

The public consultations on the revised guidelines are open until 30 September 2015. Comments should be sent using the forms provided.

Accelerated assessment and conditional marketing authorisation are intended for innovative medicines that target a disease for which no treatment is available, or that provide patients with a major therapeutic advantage over existing treatments.

Based on the experience gained in implementing accelerated assessment and conditional marketing authorisation in recent years and taking into account discussions on the optimisation of the use of these tools at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP), EMA has revised its guidelines to improve these existing frameworks. The updated guidelines are expected to optimise the use of these tools by medicine developers and consequently allow more medicines that address unmet medical needs to reach patients earlier.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002381.jsp&mid=WC0b01ac058004d5c1