EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

concept image of setting a five star goal. increase rating or ranking, evaluation and classification idea
SNSA Pilot Aims To Enhance The Quality And Consistency Of National Scientific Advice • Source: Shutterstock

EU regulators have launched an “optimized” version of their popular pilot program that allows drug developers to seek national scientific advice simultaneously from two EU member states on specific scientific, technical or regulatory issues.

The second phase of the Simultaneous National Scientific Advice (SNSA) pilot incorporates an “an optimised procedure intended to maximise the...

More from Europe

More from Geography

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By 

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.