EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation

Early results from an ongoing EU pilot on the use of clinical trial raw data in medicines evaluation have pointed to many benefits. These include fewer questions for companies and greater clarity for regulators on information submitted in marketing authorization dossiers.

Internet, business, Technology and network concept.Clinical trial 3D illustration
Access to clinical trial raw data can help regulators better understand the evidence submitted in marketing applications • Source: Shutterstock

The interim results of an ongoing pilot at the European Medicines Agency indicate that using individual patient-level data from clinical trials (also called raw data) in regulatory procedures for initial marketing authorization applications (MAAs) and post-authorization applications can enhance the evaluation process.

Key Takeaways
  • After an EU proof-of-concept pilot investigating the benefits of visualizing and analyzing clinical trial raw data to support the scientific assessment of medicinal products reached its mid-way point in December 2023, surveys were conducted with pilot participants.

  • Feedback shows there are clear early signals confirming the added value of regulatory access to raw data in support of the regulatory assessment.

  • While the US FDA Administration routinely asks for raw data as part of its assessment process, EU regulators only request for such data on an ad hoc basis, when necessary.

  • The pilot confirmed that the use of data packages requirements by other international regulators are suitable for use by EU regulators

There are “clear early signals confirming the added value of regulatory access to raw data in support of the regulatory assessment” process, the EMA

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

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Geography

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.