EMA launches a public consultation on the use of real-world data

European Medicines Agency (EMA) Launches Public Consultation on the Use of Real-World Data in the Regulation of Medicines under the Data Quality Framework for Medicine Regulation.

This consultation aims to provide a chapter for the Data Quality Framework in the regulation of medicines in the European Union.

The chapter was developed in collaboration with the Methodology Working Party and the CHMP. Additionally, it received support from the Big Data Steering Group (BDSG), an initiative organized by the EMA and HMA.

Participate in the Public Consultation until January 31, 2025

The consultation’s goal is to strengthen pharmaceutical sector regulation in the European Union, therefore, it will remain open until January 31, 2025, through the EMA website.

It is intended for professionals in research, medicine regulation, and data science experts.

Contributions can be submitted through an online survey.

Key Topics of the Public Consultation on Real-World Data (RWD)

The main topics addressed in the public consultation include:

- - First, recommendations for evaluating the quality of RWD using specific metrics;
  - Second, characterization of systems and processes for collecting reliable data;
  - Lastly, determining the relevance of data for research and medicine development issues.

What is the Data Quality Framework for Medicine Regulation?

The Data Quality Framework for Medicine Regulation is a document that supports regulatory decisions based on data quality to assess the benefit-risk relationship.

Additionally, it establishes clear criteria to ensure consistency and standardization in the evaluation of scientific data and real-world data.

What Are Its Main Objectives?

Identify and develop procedures for evaluating data quality;
Support companies in selecting reliable data sources;
Ensure trust in regulatory decisions among patients and healthcare professionals.

Why is the Public Consultation Important for Medicine Regulation?

The public consultation on the use of data in medicine regulation is crucial for improving medicine evaluation and pharmaceutical regulation policies in the European Union. In this way, this consultation will contribute to the future of medicine regulation, helping to ensure quality and transparency in regulatory processes.

Moreover, ELS’s regulatory services ensure the highest quality and transparency for all the clients we work with. As a result, we deliver outcomes with agility and compliance with new standards, while always staying up-to-date.