1. Generics Bulletin
  2. >>Policy & Regulation

European Commission Steps Further Towards ‘Ambitious’ Pharma Legislation Reform

Considering Proposals To Allow Earlier Market Entry For Generics And Biosimilars

 
• By Francesca Bruce

The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.

Touch the future,Interface technology, the future of user experience.
The European Commission Is Consulting On Ambitious Reform

In another step towards what looks set to be a major revision of the EU’s pharmaceutical legislation, the European Commission has published a consultation touching on a wide range of areas that are potentially ripe for reform. It is seeking opinions on measures to improve the incentives system, such as linking incentives to how well a company reports R&D costs, and to drive access to medicines by obliging companies to launch their products in most EU markets.

The commission says that the consultation is “the latest step towards an ambitious reform” and is part of its wider...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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
Start Free Trial

Already a subscriber?

More from Policy & Regulation

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

More from Generics Bulletin

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.