EU Project To Boost Capacity Of Medicines Regulatory Network

Those involved in the IncreaseNET initiative hope that providing more training for both new and experienced assessors will take the pressure off a regulatory network faced with a growing workload and a shortage of expertise in the face of new scientific developments.

Presentation, graphs or businessman by board for writing, growth stats or revenue in meeting.
Training of assessors is a key part of the EU initiative • Source: Shutterstock

Pharmaceutical industry representatives attending a recent meeting at the European Medicines Agency were updated on progress with an initiative intended to boost the capacity of the European medicines regulatory network (EMRN) and strengthen future collaboration among EU national competent authorities (NCAs).

A key aim of the IncreaseNET project is to improve the exchange of knowledge and good practices within the network...

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

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By 

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, H1 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By 

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

More from Agency Leadership

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

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.