EMA launches pilot project on analysis of raw data from clinical trials

On 12 July, the European Medicines Agency (EMA) announced the launch of a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of applications for new medicines, or for post-authorisation applications. The pilot will also explore practical aspects of the submission and analysis of such data.

Raw data represent individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation. Currently, the EMA regulatory system does not routinely require their submission in the context of a marketing authorisation or post-authorisation application.  

This pilot stems from one of the ten priority recommendations issued by the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) in 2020 which highlighted the need to strengthen the network’s capability to analyse data collected at individual patient level to better inform regulatory decision making. There are several potential benefits the analysis of raw data might bring, including faster evaluation through fewer questions being put to applicants and a better definition of the target treatment population. Thus, raw data analysis may enabler faster and better access to new medicines for patients.

This pilot started in September 2022 and lasts up to two years. It is open to applicants or marketing authorisation holders (MAHs) that are about to submit marketing authorisation applications or post-authorisation applications. If selected, they will include raw data already as part of their submissions. The MEB will participate in this pilot project performing analysis of raw data from clinical trials within our Agency.

More information can be found on the EMA website and in this document.

3rd Big Data Steering Group work plan published

The EMA Big Data Steering Group, set up by EMA and the Heads of Medicines Agencies (HMA), has published its third workplan that sets key actions to be delivered between 2022–25.

According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products:

Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes and facilitating earlier patient access to new treatments.

The HMA/EMA Big Data Steering Group, set up in May 2020, reviews the workplan annually to cover any new emerging topics. The workplan 2022–2025 follows the key recommendations of the former Big Data Task Force and includes activities related to medicines for human and veterinary use. 

MEB participates in simultaneous national scientific advice - pilot

The MEB provides scientific and regulatory advice in order to enhance efficiency in the development of medicines. Besides providing national scientific advice and centralised scientific advice via EMA (SAWP), MEB will now also join the simultaneous national scientific advice (SNSA) pilot, which is launched by the EU Innovation Network (EU IN). SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one National Competent Authority at the same time.

For more information regarding this type of advice and for details on how to apply, please refer to the HMA websiteInformation regarding national scientific advice can be found on the MEB’s website.  

In case of any questions, please contact nationalscientificadvice@cbg-meb.nl.

SAVE THE DATE! Next MEB Science Day – 13 April 2023

We would like to announce the next MEB Regulatory Science Day, on 13 April 2023. This day will be all about ‘Biomarkers & personalised medicine’. More information about the program and registration for this event will be available soon.

We hope that you will participate during this interesting event in the afternoon of 13 April 2023!

Inaugural lecture Peter Mol

Prof. Peter Mol is a senior assessor at the MEB. In August 2020 he was appointed professor at the Faculty of Medical Sciences of the University Medical Center Groningen. He was assigned the chair of Regulatory Science - drug regulatory decision-making and knowledge transfer. 

Due to COVID-19, the inaugural lecture was postponed earlier, but could now take place on 25 November 2022, preceded by a symposium entitled “Drugs; Regulation and Science”.

On behalf of the MEB, we would like to congratulate Peter! Curious to the inaugural lecture? You can watch it via this link.

Prof. Peter Mol