Logos of HMA-EMA (27/06/2023)

The Heads of Medicines Agencies and the European Medicines Agency set up a joint Network Data Steering Group to enhance data use in medicine regulation, supporting innovation and public health in the EU. The group coordinates efforts to strengthen data governance and management, improve data sharing and interoperability, and invest in data analytics, including AI.

Network Data Steering Group holds inaugural meeting to unlock the value of data (21/03/2025)

The Heads of Medicines Agencies and the European Medicines Agency set up the Network Data Steering Group (NDSG) to enhance data use in medicine regulation and decision-making, supporting innovation and public health in the EU. The group held its kick-off meeting in January 2025 to begin planning its work for the next three years.

How does DARWIN EU® enable real-world evidence? (26/03/2025)

A video celebrating DARWIN EU's 3rd anniversary highlights how real-world healthcare data helps regulators make better decisions on medicines. The network currently includes 30 data partners, expanding access to health data from 160 million patients across 16 European countries.

Newly issued guidance on real-world evidence and roadmap for further guidance development (26/03/2025)

Following a public consultation, the reflection paper on methodological aspects of non-interventional studies using real-world data to generate real-world evidence for regulatory purposes is now available. In addition, EMA has published a roadmap outlining real-world data related areas that could benefit from further guidance development.

New guidance for HMA-EMA Catalogues of real-world data sources and studies published (27/03/2025)

A good practice guide, a user guide, and an updated list of metadata collected in the HMA-EMA Catalogues of Real-World Data sources and studies (RWD Catalogues) are now available and offer valuable guidance on best practices for the catalogues’ users.

Discover the latest real-world data studies (27/03/2025)

A list of recently completed real-world data studies is available, providing access to their records in the Catalogue of real-world data studies.

Workshop report highlights recommendations on pharmacogenomics use to improve patient outcomes (27/03/2025)

The report makes important recommendations on the use of pharmacogenomics information in medicines development, regulation, and clinical practice to improve patient treatment outcomes. This report is the outcome of a multi-stakeholder workshop on pharmacogenomics co-hosted by the European Medicines Agencies Network and the European Commission on 24 September 2024.

European Health Data Space regulation - effective from 26 March 2025 (27/03/2025)

The new regulation aims to facilitate access to and reuse of electronic health data across the EU. It was published the EU’s Official Journal on 5 March and entered into force on 26 March 2025. This will be followed by a four-year transition period to establish the necessary electronic health data exchange infrastructures. The Network Data Steering Group will support its implementation.

Methodology Working Party: workplan published (27/03/2025)

The Methodology Working Party (MWP) has published its three-year workplan for 2025-2027, including activities planned on data and analysis, as well as AI. The MWP was established by the Committee for Medicinal Products for Human Use (CHMP) in order to pool and use expertise in key areas such as biostatistics, modelling and simulation, pharmacogenomics, real-world evidence and AI.

New EU clinical trial map launched (27/03/2025)

The new Accelerating Clinical Trials in the EU (ACT EU) Trial Map is now available on the Clinical Trials Information System (CTIS) website. It provides patients and healthcare professionals with real-time information about clinical trials in their area. This map supports searches by geographic area and medical condition in lay language.

Open procurement procedure for contractors for studies to support regulatory decisions (27/03/2025)

EMA is seeking organisations capable of conducting high-impact research on the quality, safety, and effectiveness of medicines including vaccines. This research will generate evidence to support regulatory decision-making. The deadline for receipt of tenders is 30 April 2025.

Vision for clinical evidence by 2030: key principles to enhance patient-centric clinical research (27/03/2025)

The European medicines regulatory network’s vision for clinical evidence outlines 6 guiding principles for generating excellent clinical evidence that is patient-guided, data-driven and transparent. Excellence in clinical evidence is crucial for well-informed decisions on medicines.

Product Management Service (PMS) information day - 21 May 2025 (21/05/2025)

This event aims to enhance awareness and offer comprehensive insights into the implications of the Product Management Service for key stakeholders.

Routine clinical study data submission holds promise of faster medicine authorisation (18/12/2024)

The interim results of the clinical study data (‘raw data’) proof-of-concept pilot are available. Launched in 2022, the pilot investigates the benefits of analysing clinical study data to support the scientific assessment of medicinal products.

Have your say on data strategy for European medicines regulatory network (09/12/2024)

Public consultation is open until 31 December 2024. The strategy aims to maximise the use of and benefits from data hosted by the medicines regulatory network. It aims to ensure that data is appropriately organised, standardised, of high-quality and easily shareable among regulators and stakeholders to facilitate collaboration and informed medicines decision-making.

Share your view on applying Data Quality Framework for EU medicines regulation to real-world data (09/12/2024)

A public consultation is open until 28 February 2025. The draft real-world data chapter provides guidance on assessing the quality of real-world data used in medicines assessment. It aims to enhance the usefulness of real-world evidence in medicines regulatory decisions.

Discover latest real-world data studies (17/12/2024)

A list of recently completed real-world data studies is available, providing access to their records in the Catalogue of real-world data studies.

Share your experience on using real-world data catalogues (17/12/2024)

Please complete a survey to provide feedback on the utility of the HMA-EMA Catalogues of real-world data sources and studies. The survey is open until 17 January 2025 and will help identify areas for potential improvement that can enhance the user experience.

Could data from mobile health and social media support decisions on medicines? (17/12/2024)

The HMA-EMA Big Data Steering Group has published two expert reports exploring if mobile health and social media data can be potentially used for medicines regulatory decision-making.

Veterinary Big Data: 2024 highlights (29/11/2024)

EMA’s Veterinary Analytics Team had a successful and productive 2024, marked by important achievements and increased engagement with stakeholders.

Progressing towards more data-driven medicines regulation: a look into 2024 highlights (17/12/2024)

An annual report of the Big Data Steering Group is available which provides a summary of the key activities and accomplishments during 2024. It also includes highlights of the HMA-EMA AI workplan delivery in 2024.

Artificial Intelligence in European medicines regulation: from vision to action (17/12/2024)

This perspective article explores how the European medicines regulatory network plans to enable the safe and responsible use of artificial intelligence at all stages of the medicine lifecycle for the benefit of public and animal health.

Insights from international regulators' collaborative real-world evidence on COVID-19 (11/12/2024)

This review article reflects on three years of global regulatory agency collaboration to address challenges related to real-world evidence generation and observational studies during the pandemic. The work was conducted under the International Coalition of Medicines Regulatory Authorities (ICMRA).

Evidence generation for paediatric medicines: collaborative findings on extrapolation by EMA and EUnetHTA (17/12/2024)

The joint EMA and Health Technology Assessment (HTA) publication discusses evidentiary requirements for small populations using evidence transfer and the use of prior knowledge to support decision-making.

HMA/EMA Big Data Stakeholder Forum 2024 – 28 November 2024 (18/12/2024)

The annual forum has held to discuss progress on big data and evidence generation, as well as the use and exchange of medicines data across the EU network. The discussion outcomes will be used to guide the planning of the next phase of data activities delivery outlined in the Network strategy.

HMA/EMA multi-stakeholder workshop on Artificial Intelligence – 5 November 2024 (18/12/2024)

A workshop was held to discuss next steps related to the AI reflection paper, including AI use cases in the medicine lifecycle and progress updates on the HMA-EMA multi-annual AI workplan. The event also featured keynote speakers who shared their insights on the latest developments in AI, as well as policy and legislative environments.

Second bi-annual Big Data Steering Group and industry stakeholders meeting - 25 October 2024 (18/12/2024)

Objectives of this meeting are to engage in an open dialogue with industry stakeholders on selected big data topics and to share key progress updates regarding the delivery of the BDSG workplan. The topics discussed during this meeting included real-world evidence generation, network data governance rationalisation and the interim results of the clinical study data pilot.

4th Veterinary Big Data Stakeholder Forum: recording now available (28/11/2024)

On 14 October 2024, the Agency hosted the 4th edition of the annual Veterinary Big Data Stakeholder. The recording of the event, together with the speaker's presentations, is now publicly available.

Reflection paper on the use of AI in the medicinal product lifecycle (01/10/2024)

Following a public consultation, the reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle has been published. It provides considerations on the use of AI in the lifecycle of medicinal products and describes the current experience of the EU medicines regulators while scientific knowledge on AI is fast evolving.

Fourth veterinary big data stakeholder forum (14/10/2024)

The annual edition of the Veterinary big data stakeholder forum is part of the implementation of the EU veterinary big data strategy.

HMA-EMA multi-stakeholder workshop on Artificial Intelligence (05/11/2024)

The workshop will feature keynote speakers providing updates on the latest in AI developments, and policy and legislative environment. There will be an opportunity to discuss next steps related to the AI reflection paper. Further discussions will cover AI use cases in the medicine lifecycle as well as the progress and possible updates to the HMA-EMA multi-annual AI workplan.

Fifth HMA-EMA Big Data multi-stakeholder forum 2024 (28/11/2024)

The upcoming forum will share and discuss progress on big data and evidence generation, as well as the use and exchange of medicines data across the EU network. These discussions will inform the update of the HMA-EMA Big Data Steering Group workplan, strengthening collaboration with partners and stakeholders on the delivery of data activities included in the Network strategy.

We need your feedback: participate in our survey to help improve communication and engagement (30/09/2024)

The Big Data Steering Group is assessing communication and engagement efforts with partners and stakeholders on the journey towards more data-driven medicine regulation. The survey takes less than 10 minutes to complete, and your feedback is valuable!

Harnessing AI in medicines regulation: principles on the use of large language models (LLMs) (30/09/2024)

EMA and the Heads of Medicines Agencies have published guiding principles and recommendations for the EU medicines regulatory network staff using LLMs in their work. The purpose of these principles is to help the Network staff understand the potential benefits and limitations of LLMs. This will enable them to leverage this technology safely and effectively while avoiding associated risks.

Regulator-led real-world data (RWD) studies to support medicines decision making (30/09/2024)

The second report on conducting studies with real-world data has been published, based on experience gathered between February 2023 and February 2024. The report highlights the European Medicines Regulatory Network's continued efforts to better integrate real-world evidence (RWE) into regulatory decisions on medicine development, authorisation and monitoring.

Catalogue of real-world data studies: driving non-interventional research in Europe (30/09/2024)

Since its launch in February 2024, the catalogue has 151 newly registered studies, bringing the total number of studies to 2,909. This significantly contributes towards enhancing transparency and fostering research based on real-world data in Europe.

Consultation on medicines studies procurement (30/09/2024)

EMA has initiated a preliminary market consultation to gather insights and assess the market's ability to conduct scientific studies related to the quality, safety, and efficacy of medicines for human and veterinary use. Interested organisations can participate in this consultation until 11 October 2024.

Data science training opportunities for the regulatory network (30/09/2024)

The first training modules of the Data Science curriculum are now available to the EU medicines regulatory network’s staff through the EU Network Training Platform (EU NTC). These modules provide an introduction to various data science topics including AI, big data, data management and data visualisation.

Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics - 24 September 2024 (23/09/2024)

A multi-stakeholder workshop was held to identify priority areas for regulatory action to promote the clinical implementation of pharmacogenomics, discuss how medicine regulators can facilitate its uptake by national healthcare systems, leverage genomic data linked to real-world sources, and increase the regulatory impact of EU-funded projects in personalised medicine.

Multi-stakeholder workshop on pharmacogenomics (24/09/2024)

The workshop aims to identify priority areas for regulatory action in pharmacogenomics, discuss how regulators can promote genomics in healthcare systems, leverage genomic data linked to real-world sources and increase the regulatory impact of EU-funded projects in personalised medicine.

Joint HMA-EMA workshop on Artificial Intelligence (05/11/2024)

SAVE THE DATE!

Calling all data holders: register your data source to help unlock the power of real-world data (17/06/2024)

Do you hold or know someone who holds a data source? Join us in unlocking the potential of real-world data (RWD) by registering your data source in the Catalogue of RWD sources or encouraging others to do so.

EMA support to real-world evidence (25/06/2024)

EMA has published a summary guide for EU regulators and decision-makers on how the Agency can support the delivery of regulator lead real-world evidence to aid decision-making. The guide includes descriptions of the available types of real-world data studies, optimal resources for addressing research questions and details about the process for requesting these studies.

HMA-EMA Big Data stakeholder forum 2024 (28/11/2024)

SAVE THE DATE!

Public consultation on real-world evidence reflection paper (25/06/2024)

A reflection paper on non-interventional studies that use real-world data to generate real-world evidence for regulatory purposes is available for public consultation. All interested partners and stakeholders are invited to provide feedback by 31 August 2024.

International collaboration on real-world evidence (25/06/2024)

ICH adopted a reflection paper to further enable real-world evidence integration into regulatory decision-making across the world. Furthermore, the ICH M14 draft guideline on non-interventional pharmacoepidemiological studies for safety assessment of medicines is open for public consultation until 30 August 2024.

Report on patient registries workshop 12-13 February 2024 (25/06/2024)

The report on the workshop, which focused on the registries use for regulatory purposes, is now available. It summarises the discussions and highlights recommendations to optimise the qualification of novel methodologies for patient registries. The report also identifies ways to improve data quality, discoverability and assess the fitness for purpose of data sources for regulatory decisions.

Report of clinical trial analytics workshop (11/04/2024)

The ACT EU workshop on 25-26 January 2024 highlighted a collective ambition to improve the use of data about clinical trials, with a multi-stakeholder approach to identify research priorities. This will speed up the development of an analytics ecosystem that maximises health benefits for EU citizens. A report summarising the discussion has been published on the ACT EU website.

Joint HMA-EMA Big Data Steering Group workshop on RWE methods - 14 June 2024 (14/06/2024)

A workshop was held to gather input from stakeholders and experts on the draft RWE reflection paper, as well as priorities for further regulatory guidance development and collaboration. The aim was also to engage participants in discussions around RWE methods in regulatory decision making.

Biannual Big Data Steering Group and industry stakeholders meeting - 23 May 2024 (23/05/2024)

Objectives of this meeting are to have an open dialogue and hear industry’s perspective on selected big data topics and to inform industry stakeholders on key progress concerning the BDSG workplan delivery.

Methodology Working Party Interested Parties meeting - 7 June 2024 (27/06/2024)

The regular Interested Parties meeting provides stakeholders with a platform to share their reflections on relevant methodological topics and engage in discussions with members of the Methodology Working Party (MWP) and the Methodology European Specialised Expert Community (Methodology ESEC).

Now available: HMA-EMA catalogues of real-world data sources and studies (19/03/2024)

The new electronic catalogues were launched on 15 February 2024 and have replaced the former ENCePP Resource Database and EU PAS Register. These enhanced, publicly available catalogues provide a valuable resource for medicines regulators and stakeholders who need to use data for medicines regulation.

The capacity of DARWIN EU® for conducting RWD studies continues to expand (19/03/2024)

With additional data partners in the network DARWIN EU® continues to increase its capacity for real-world data (RWD) studies. This follows the completion of its two year-establishment phase that started when the Coordination Centre was set up in February 2022.

Clinical trials ‘raw data’ pilot: last places open to participate (19/03/2024)

The pilot, which aims to include a total of ten regulatory procedures, has recently selected its sixth and seventh procedures. These two procedures are initial marketing authorisation applications in the fields of oncology and gastroenterology.

Scientific Explorer – AI enabled knowledge mining solution for EU regulators (19/03/2024)

Scientific Explorer, launched in March 2024 and driven by AI, aids regulatory network staff in their daily work by enabling easy, focused, and precise searching of regulatory and scientific information. The first release is dedicated to scientific advice procedures for human medicines. EU network staff are invited to attend training sessions to learn more about Scientific Explorer.

Big Data Steering Group annual report 2023 (19/03/2024)

The report provides a summary of the key activities and accomplishments of the Big Data Steering Group during 2023 as it works towards a more data-driven approach to medicine regulation.

Midterm report on 2025 network strategy (19/03/2024)

The midterm report offers a snapshot of the achievements made from January 2021 to June 2023. It reviews the original goals and objectives as well as the actions to achieve them.

Major update of the SME user guide (19/03/2024)

The new release includes updates to reflect changes in the EU’s legal and regulatory framework for the development and authorisation of medicines for human and veterinary use.

EU Network training webinar: use of Scientific Explorer in scientific advice regulatory procedures (03/04/2024)

EMA scientific committee members, NCAs assessors, and EMA staff who work with scientific advice procedures or marketing authorisation procedures are invited to attend this webinar. The purpose of the webinar is to demonstrate how Scientific Explorer, an AI-enabled knowledge mining tool, can assist in finding relevant information more efficiently and effectively.

Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies: 4 March 2024 (19/03/2024)

This event was held to provide an overview of the newly launched catalogues highlighting their benefits and significance in regulatory practices. In addition, the event included a demonstration showcasing the key features of the Catalogues.

Multi-stakeholder workshop on data quality framework for Adverse Drug Reaction reporting: 1 March 2024 (19/03/2024)

The workshop was held to gather input from stakeholders involved in Adverse Drug Reaction (ADR) reporting. The aim of this workshop was to bring together experts in the field, build on their extensive experience, and exchange knowledge related to improving ADR data quality.

Multistakeholder workshop on Patient Registries: 12-13 February 2024 (19/03/2024)

The workshop took place to discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify limitations and propose measures to optimise the process. The meeting also considered contexts of use for which registry data are ‘fit for purpose’ including tools to support data discoverability and assessment.

ACT EU Clinical Trials Analytics Workshop, 25-26 January 2024 (19/03/2024)

The workshop was held to explore potential use cases for accessing clinical trials data and performing data analysis. In addition, the meeting sought input on identifying evidence gaps within the EU clinical trials environment. Participants were also informed about international efforts towards standardising clinical trials data and clinical trial analytics attached to the ACT EU multi-stakeholder platform.

Publication of Artificial Intelligence workplan to guide use of AI in medicines regulation (13/12/2023)

EMA and the Heads of Medicines Agencies (HMAs) have endorsed an Artificial Intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.

Data Quality Framework sets the standard for health data (13/12/2023)

The final version of the Data Quality Framework for EU medicines regulation has been published following a public consultation. This guideline sets out the criteria for a more consistent and standardised approach to the quality of data used in medicine regulation to support benefit-risk decisions.

Get ready for the launch of data sources and studies catalogues in February 2024! (13/12/2023)

The go-live date in February 2024 for the EMA-HMA catalogues of data sources and non-interventional studies is approaching. A downtime period of the ENCePP Resources Database and EU PAS Register is expected from 22 January to 15 February 2024 to enable preparation of the go-live.

DARWIN EU® continues to scale up in its second year of establishment (14/12/2023)

DARWIN EU® is in the process of onboarding ten additional data partners to expand its capacity to deliver real-world evidence-based studies. These studies provide valuable insights to support regulatory decision-making throughout the lifecycle of a medicinal product.

Real-world evidence and data sources training opportunities for regulatory network (14/12/2023)

We are pleased to announce the launch of the Big Data training curricula with the rollout of the first two modules related to the Pharmacoepidemiology and Real-World Evidence (RWE) domain.

Webinar on the Union Product Database Data Quality Framework, 11 January 2024 (11/01/2024)

National competent authorities (NCAs) are invited to attend this session for a progress report on the UPD Data Quality Framework

ACT EU Clinical Trials Analytics Workshop, 25-26 January 2024 (25/01/2024)

Participants will share their use cases which might be addressed by access to clinical trials data, data analysis, and funding; provide input on evidence gaps within the EU clinical trials environment and be informed how international data standardisation efforts on clinical trials led by ICH M11 are enabling new use cases and support implementation.

HMA/EMA Multistakeholder Workshop on Patient Registries, 12-13 February 2024 (12/02/2024)

The workshop will discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify limitations and propose measures to optimise the process. It will also seek to establish the value and enable the use of patient registries for regulatory decision-making.

Methodology Working Party stakeholder interaction meeting, 7 December 2023 (14/12/2023)

The virtual meeting with stakeholders was held to consolidate comments received during the public consultation on the revised Methodology Working Party (MWP) workplan. The objective of the meeting was to shape the updated MWP workplan for final endorsement at the Committee for Medicinal Products for Human Use (CHMP) preparatory and organisational matters (PROM) plenary meeting.

HMA/EMA Big Data Stakeholder Forum 2023, 4 December 2023 (14/12/2023)

The annual meeting was held to update participants on the delivery of big data activities under the Network Strategy to 2025. Discussions with stakeholders took place on further opportunities for big data in medicines development and regulatory decision-making. In addition, keynote speakers shared their insights on cutting-edge topics.

Third Veterinary Big Data Stakeholder Forum, 23 November 2023 (14/12/2023)

The event reported on the EU Veterinary Data Hub activities and the HMA/EMA Veterinary Big Data workplan, discussed use cases, future needs and upcoming challenges of big data in the veterinary regulatory domain.

Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world, 20-21 November 2023 (14/12/2023)

The workshop took place to discuss with stakeholders the latest developments in artificial intelligence (AI) technology, policy, and its potential applications in medicines regulation. Activities undertaken by HMA/EMA to address stakeholder priorities on AI, as well as the draft AI reflection paper were also discussed.

Halfway point of clinical trials ‘raw data’ pilot – applicants can still register to participate (27/09/2023)

The proof-of-concept pilot has selected its fifth regulatory procedure and reached the halfway point in its journey to test the role of analysis of clinical trials ‘raw data’ submitted to EMA in electronic structured format. The last selected procedure relates to an initial marketing authorisation application in gastroenterology.

HMA/EMA Big Data Steering Group updates its workplan to accelerate transformation to data-driven medicines regulation (27/09/2023)

The HMA/EMA Big Data Steering Group workplan has been enhanced including work on national regulatory use cases for real-world evidence (RWE), intensified work on artificial intelligence (AI) and public consultation on patient experience data (PED).

Watch this space: launch of EMA-HMA catalogues of data sources and non-interventional studies in early 2024 (27/09/2023)

The European Medicines Regulatory Network is developing two new public catalogues, one for real-world data sources and one for non-interventional studies. These catalogues will replace and enhance the current ENCePP Resources Database and the EU PAS Register at the beginning of next year.

DARWIN EU: Data partners expression of interest deadline - 31 October 2023 (27/09/2023)

EMA is looking for new data partners to collaborate with DARWIN EU®. If your public or private organisation has access to real-world healthcare data, you might be interested in becoming a new data partner in DARWIN EU®. The data could contribute to studies that generate real-world evidence supporting scientific evaluation and regulatory decision-making on medicines in the EU.

Open consultation: draft reflection paper on the use of artificial intelligence (AI) in medicines lifecycle (27/09/2023)

The European Medicines Regulatory Network is inviting interested stakeholders to comment on the AI draft reflection paper. This paper outlines current views on the use of AI in the lifecycle of human and veterinary medicines. The public consultation is open until 31 December 2023.

Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis (27/09/2023)

EMA is funding a research project entitled “Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis”.

Veterinary Data Hub established (27/09/2023)

Established in June 2023, the Veterinary Data Hub brings together a multidisciplinary team of Network experts from Belgium, France, Germany, Portugal, Spain and Sweden. This group of experts collaboratively engages in advancing the EU Veterinary Big Data strategy and contributes to the planned activities within this framework.

Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world (20/11/2023)

The objectives of this workshop are to engage stakeholders with keynote speakers on AI developments in technology, policy and potential applications in medicines regulation, inform on the HMA/EMA activities to deliver the stakeholder’s priorities on AI and discuss with stakeholders and experts the draft AI reflection paper.

Third Veterinary Big Data Stakeholder Forum (23/11/2023)

The event aims to report on the EU Veterinary Data Hub activities and the HMA/EMA Veterinary Big Data workplan. Furthermore, it will resume the discussion on the identified use cases, collect inputs, and learn from existing experiences from stakeholders’ experts as well as discuss upcoming challenges and future needs of big data in the veterinary regulatory domain.

Biannual Big Data Steering Group and industry stakeholders meeting (27/11/2023)

Objectives of this meeting are to have an open dialogue and hear industry’s perspective on selected big data topics and to inform industry stakeholders on key progress concerning the BDSG workplan delivery.

HMA/EMA Big Data Stakeholder Forum 2023 (04/12/2023)

The forum aims to inform and strengthen collaboration with partners and stakeholders on the delivery of big data activities of the Network Strategy to 2025, discuss further big data opportunities in medicines development and regulatory decision making as well as engage participants with keynotes speakers on cutting-edge topics.

Review of experience with real-world data studies in medicines assessment (21/06/2023)

Report published on experience gained in conducting real-world data studies as part of the EU Network’s efforts to enable the use of real-world evidence in regulatory decision making.

DARWIN EU® open call for interest for new data partners (08/06/2023)

The open call for expression of interest to become a potential data partner in DARWIN EU®, launched in March 2023, remains continuously open. To date, the call generated sixty-six (66) responses from eighteen (18) countries including several multi-national data networks. Interested data partners are invited to visit the DARWIN EU® website for further information including FAQs.

Interested to be part of a pilot assessing the benefits of access to clinical trials raw data? (08/06/2023)

The pilot continues to welcome expressions of interest to participate from applicants or marketing authorisation holders (MAHs) that are planning to submit a marketing authorisation application or post-authorisation application to EMA.

Watch this space - open consultation on AI use in medicines regulation to be launched soon (09/06/2023)

A draft CHMP/CVMP reflection paper on the use of artificial intelligence and machine learning in the medicinal product lifecycle will soon be published. It will provide an opportunity to stakeholders to contribute to shaping AI’s future use in medicines regulation.

EU Veterinary Big Data: we have a plan! (07/06/2023)

The discussions around big data in the veterinary domain are moving from vision to action following endorsement of the EU Veterinary Big Data workplan to 2025 by the Heads of Medicines Agencies in May 2023.

Revised mandates of the key bodies governing data for medicines regulators (09/06/2023)

HMA and EMA Management Board recently endorsed revised mandates of the two main data governance bodies of the European medicines regulatory network - the Network Data Board and the Big Data Steering Group. The revisions reflect evolution to the mandates of these bodies to clarify their scope, division of responsibilities, composition and stakeholder engagement models.

ICH progresses a new reflection paper on real-world evidence (20/06/2023)

Building on the 2022 ICMRA workshop hosted by EMA, in June 2023 the ICH Assembly decided to launch a public consultation on a new paper “International Harmonisation of RWE Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using RWD, with a Focus on Effectiveness of Medicines”.

Multi-stakeholder workshop on real-world data quality and experience in use of real-world evidence for regulatory decision-making: 26-27 June 2023 (26/06/2023)

The workshop with stakeholders was held to address real world data quality linked to the EU Data Quality Framework as well as recent use of real world evidence in the regulatory decision making.

Biannual Big Data Steering Group and industry stakeholders meeting: 26 May 2023 (28/06/2023)

The most recent meeting was held in May 2023 to continue the dialogue and inform industry stakeholders on key progress concerning the BDSG workplan delivery.

Multi-stakeholder workshop on qualification of novel methodologies: 17-18 April 2023 (28/06/2023)

A multi-stakeholder workshop was held to explore the scope, process and outcomes of the qualification of novel methodologies platform.