Legislative Overhaul 'Will Not Make EU A Global Leader' In Pharma R&D

Industry Says 'Flexible And Coherent’ Regulatory System Needed

National pricing and reimbursement systems remain a key barrier to medicines access, and requiring companies to market their products in all EU countries and to notify regulators of their launch intentions is not the answer, according to EuropaBio, which represents a wide range of biotech firms operating in Europe.

Extruded political Map of European Union with relief without United Kingdom after anticipated Brexit
The EU is in search of an improved legislative environment for medicines • Source: Alamy

Efforts by the EU authorities to improve the drug regulatory environment have met with a lukewarm response from industry body EuropaBio. It says the proposed revision of the EU pharmaceutical legislation “does not align with the European Commission’s bid to promote the EU as a competitive global leader in biopharmaceutical R&D.”

EuropaBio claims that “little in this revision seeks to address the issues we face for next-generation medicine development, and errs...

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

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By 

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.