1. Pink Sheet
  2. >>Geography
  3. >>Europe

Bigger Trials, More RWE Needed for Future Crisis Response, Say EU Regulators

 
• By Ian Schofield

A report from the EU medicines regulatory network looks at what was done well in the response to the COVID-19 pandemic, and what needs to be improved if we are to be better prepared next time. 

Coronavirus mutation inside human body - flu outbreak or coronaviruses influenza
The EU needs to be better prepared for a future disease outbreak • Source: Shutterstock

Larger, more methodologically sound clinical trials and an infrastructure for producing real-world evidence will be two of the key requisites for regulatory decision-making in the event of a future health emergency, says a new report from the European Medicines Agency and the Heads of Medicines Agencies.

Regulators will also need enough reserve resource capacity to support crisis-related work such as accelerated reviews for pandemic products, and regulatory processes within the EU network will need to be further streamlined while maintaining existing “rigorous quality standards”,

In the meantime, it says, resourcing issues, clinical trials, medicine shortages and real-world evidence are “priority areas being pursued currently” within the EU medicines regulatory network (EMRN), and some changes have been

More from Europe

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Geography