1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

Also, News From France, The US, And The UK

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Regulatory Recap
(Shutterstock)

The EU Council has finally adopted its position on the pharmaceutical package, which will now be negotiated with the EU Parliament.

The off-patent drug trade group Medicines for Europe described it as “an important step for progress in pharmaceutical regulation in...

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 Regulation

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

More from Generics Bulletin

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
• By Dean Rudge

In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
• By Dave Wallace

As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.