1. Pink Sheet
  2. >>Geography
  3. >>Europe

EU Consults On Data Quality Framework For Medicines Regulation

 
• By Vibha Sharma

The EU is taking steps to establish a more consistent and standardized approach to the quality of data used in medicines regulation to support benefit-risk decisions.

Standard Quality Control Certification Assurance Guarantee Concept. 3D rendered illustration
EU Wants To Improve The Quality Of Data That Underpins Regulatory Decision-Making • Source: Shutterstock

Regulators in the EU are inviting feedback on a draft framework that seeks to define quality requirements for all types of data used in regulatory decision-making. When finalized, it can help drug companies and other stakeholders in selecting appropriate current and novel data sources for their studies. 

The data quality framework (DQF) was developed by the European Medicines Agency, the EU Heads of Medicines Agencies and the ongoing joint action initiative for delivering European principles for the...

More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.