Pilot Shows EU Needs A ‘Robust’ Shortage Signaling System for ‘Critical’ Drugs

EU pharma companies see manufacturing and logistics issues as the main cause for supply problems, but are concerned about the costs of investing in and gaining regulatory approval for new or updated production facilities, according to a new report.

pharmaceutical production line
Manufacturing issues are the root cause of many drug shortages • Source: Shutterstock

The EU needs a “robust signaling system” that can accurately detect and mitigate vulnerabilities in the supply chains for “critical” medicines using a risk-based approach with harmonized definitions and quality standards, says a new report from the European Commission’s Health Emergency Preparedness and Response Authority (HERA).

Marketing authorization holders (MAHs) see manufacturing and logistical issues as the main reasons for supply chain discontinuities, notably the complexity...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

More from Geography

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.