European Shortages Monitoring Platform (ESMP) fully operational (21/03/2025)

European Shortages Monitoring Platform (ESMP) fully operational

New Fee Regulation Effective 1 January 2025 (21/03/2025)

New Fee Regulation Effective 1 January 2025

HTA Regulation Effective 12 January 2025 (21/03/2025)

HTA Regulation Effective 12 January 2025

Consolidated advice on clinical trials (21/03/2025)

Consolidated advice on clinical trials

ICH E6 R3 principles and Annex 1 published (21/03/2025)

ICH E6 R3 principles and Annex 1 published

New clinical trial map launched in the EU (21/03/2025)

New clinical trial map launched in the EU

Best practice guide for trials not transitioned (21/03/2025)

Best practice guide for trials not transitioned

20th anniversary of SME Regulation (20/03/2025)

20th anniversary of SME Regulation

EU Biotech and Biomanufacturing Hub (20/03/2025)

The European Commission has launched an EU Biotech and Biomanufacturing Hub with support available at EU level. From start-up to scaling up, the hub provides easy and accessible information on relevant EU legislation, funding opportunities and business support networks.

Launch of scientific advice for high-risk medical devices (11/03/2025)

A dedicated scientific advice procedure has been established to assist manufacturers of certain high-risk medical devices. This procedure allows them to receive feedback on their proposed clinical development strategies and clinical investigation plans.

Update guidance for class I integral medical devices (11/03/2025)

The questions and answers document on the implementation of EU regulations on medical devices and in vitro diagnostic medical devices has been updated. It addresses cases where a declaration of conformity is not available for class I integral medical devices (excluding Is – sterile condition and Im – measuring function devices). MAHs may submit a statement of compliance with the relevant general safety and performance requirements to meet requirements of Article 117 of the Medical Devices Regulation.

New tender launched for EMA-funded quality, safety, and efficacy studies (11/03/2025)

An open procurement procedure for pre- and post- authorisation studies to support regulatory decision making on human and veterinary medicines has been launched. The studies will cover a broad range of research areas such as translational, veterinary, methodological/statistical, qualitative, and pharmaco-epidemiological (non-interventional), as well as topics on innovative technologies for manufacturing and quality control of medicines, and computational methods for comparison of molecular structural features (see details in EU Funding & Tenders Portal).

New reports available (20/03/2025)

New reports available

SPOR updates (20/03/2025)

SPOR updates

IRIS live for post-authorisation procedure management (human and veterinary medicines) (21/03/2025)

IRIS live for post-authorisation procedure management (human and veterinary medicines)

Clinical Trials Information System (CTIS) sponsor end user training programme - March 2025 (25/03/2025)

The Agency offers a virtual training programme to support sponsor user preparedness concerning the new way of submitting Clinical Trial Applications (CTA) in the EEA via the new Clinical Trial Information System (CTIS) and in compliance with the Clinical Trial Regulation No. 536/2014.

Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V) (10/04/2025)

The Agency invites all human and veterinary stakeholders to a system demonstration session followed by questions and answers on the Certificates Processing System, the system to order EMA certificates of medicinal products.

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system (12/05/2025)

The Agency organises a training course on the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities.

Editorial (11/12/2024)

Welcome to the latest edition of the SME newsletter.

Orphan devices pilot program (12/12/2024)

The EMA has launched a pilot programme for the expert panels to support medical device manufacturers and notified bodies on the orphan device’s status and the clinical evidence for these devices in the premarket phase.

New Fee Regulation Effective 1 January 2025 (11/12/2024)

As from 1 January 2025, the EMA's fees will be governed by a new regulation (Regulation (EU) 2024/568) which will bring significant changes to the fees structure, levels and the way incentives are applied for SMEs. Key changes include:

European Shortages Monitoring Platform (11/12/2024)

On 28 November 2024, the European Shortages Monitoring Platform (ESMP) was released for routine shortage reporting by marketing authorisation holders (MAHs). The ESMP will enable information exchange for the prevention, identification and management of shortages to ensure medicines are available for patients in the EU. The use of the platform will become mandatory for centrally authorised products shortage reporting with the full release of the platform on 2 February 2025.

New Medicine Shortage Communications (11/12/2024)

In October 2024, the EMA launched a 6-months pilot programme for a new Medicine Shortages Communication (MSCs), which will be published instead of Direct healthcare professional communications (DHPCs), for critical shortages without quality, safety, or efficacy issues, and related to commercial reasons, demand surges, and supply capacity. The EMA will approach companies directly during the pilot programme to request an MSC (webpage).

Union List of Critical Medicines (11/12/2024)

The list aims to ensure the availability of critical medicines across the EU by prioritising them for actions to strengthen their supply chains and minimise supply disruptions. The list was released in two phases. The first version included medicines reviewed at the EU level from six national lists (Finland, France, Germany, Portugal, Spain, and Sweden). The second version includes additional medicines sourced from crisis preparedness lists and stakeholder consultations (webpage).

Shortage Prevention Plans and Shortage Mitigation Plans (11/12/2024)

The HMA/EMA has launched a pilot programme to implement shortage prevention plans (SPP) and shortage mitigation plans (SMP). The pilot program aims to facilitate the implementation of SPP and SMPs by marketing authorisation holders and competent authorities and to collect feedback from industry stakeholders. SMEs are invited to participate and share their experience with EMA on a voluntary basis. Further information can be found here.

Revision of the Good Clinical Practice ICH E6 (R3) (11/12/2024)

Revision of the Good Clinical Practice ICH E6 (R3)

Guidance on the application of the amended Variations Regulation from 1 January 2025 (11/12/2024)

Guidance on the application of the amended Variations Regulation from 1 January 2025

Approval of the 1st vaccine platform technology master file (11/12/2024)

Approval of the 1st vaccine platform technology master file

Guideline on risk management requirements for elemental impurities for consultation (11/12/2024)

Guideline on risk management requirements for elemental impurities for consultation

EMA Veterinary Innovation Day (13/03/2025)

EMA will be hosting the second edition of the Innovation Day for veterinary medicines on 13 – 14 March 2025. The hybrid event will include sessions on the EU legislative framework for veterinary medicinal products and the Agency’s support to innovation and veterinary medicines.

New QRD template (11/12/2024)

From 10 March 2025 applicants will have to use version 9.1 of the veterinary QRD product information. The new templates will be available in all EU languages by the end of January 2025.

Public consultation on the draft Real World data chapter of the Data Quality Framework (11/12/2024)

The EMA launched a public consultation on a draft real-world data (RWD) chapter of the Data Quality Framework for EU medicines regulation.

Emergency Task Force (ETF) (11/12/2024)

A new page on the Emergency Task Force (ETF) activities of EMA has been launched.

New oncology webpage and newsletter (16/12/2024)

A new cancer medicines webpage has been launched on the EMA’s website.

Recent events (11/12/2024)

Recent events

Editorial (03/10/2024)

Welcome to the latest edition of the SME Newsletter.

New Fee Regulation (02/10/2024)

Regulation (EU) 2024/568 on fees and charges payable to the EMA (‘The New Fee Regulation’) will be apply from 1 January 2025.

Pilot for orphan medical devices (02/10/2024)

EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union. It offers free advice to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation.

European Shortages Monitoring Platform (02/10/2024)

The EMA is setting up the European Shortages Monitoring Platform (ESMP) to collect information on the supply and demand of medicines to prevent, detect, and manage human medicines’ shortages in the European Union and the European Economic Area (EU/EEA). The EMA plans to deliver the first functionalities of the platform available to Marketing Authorisation Holders (MAHs) by the fourth quarter of 2024.

Pack size submission in XEVMPD (02/10/2024)

Pack size submission in XEVMPD

Shortage prevention and mitigation plan (02/10/2024)

Shortage prevention and mitigation plan

New guidance documents for the joint clinical assessments (02/10/2024)

Two new guidance documents have been published for the joint clinical assessments under the EU Health Technology Assessment (HTA) Regulation:

Artificial Intelligence (13/02/2024)

The EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network using large language models (LLM) in their work. These guiding principles are one of the deliverables of the EMA/HMA Multiannual workplan on Artificial Intelligence up to 2028.

Improved search for clinical trials in CTIS (02/10/2024)

Improved search for clinical trials in CTIS

Clinical trials advice pilot programmes (02/10/2024)

Clinical trials advice pilot programmes

Updated CTIS training materials (02/10/2024)

Updated CTIS training materials

Other news on clinical trials (02/10/2024)

Other news on clinical trials

Human medicines (02/10/2024)

Human medicines

Veterinary medicines (02/10/2024)

Veterinary medicines

Human medicines (02/10/2024)

Human medicines

Veterinary medicines (02/10/2024)

Veterinary medicines

Human and veterinary medicines (02/10/2024)

Human and veterinary medicines

Webinar on the Union Product Database (UPD) (17/10/2024)

The session will provide an overview of the UPD Industry Application Programming Interface, and will demonstrate endpoint access and data read for veterinary marketing authorisation holders.

CTIS Information Day (17/10/2024)

This event is organised for CTIS users and will include an update on transitioning trials and the implementation of the revised transparency rules.

SME Info Day (18/10/2024)

This training event for small and medium-sized enterprises in the pharmaceutical sector will provide an update on regulatory topics related to medicines for human use. This event will cover various topics such as EMA scientific advice, clinical trials, medical devices, the new EU HTA regulation, the new EMA fee regulation and medicine shortages.

ACT EU MSP Annual Meeting (22/10/2024)

The EMA is organising a meeting of the Multi-Stakeholder Platform (MSP) to review the key achievements of ACT EU since its inception, discuss the current clinical trials landscape and look at future opportunities.

HMA/EMA Multi-Stakeholder Workshop on Artificial Intelligence (05/11/2024)

The workshop will provide an update on the state of the art in Artificial Intelligence (AI), the policy and legislative environment and its impact on the revision of the AI reflection paper.

Translating innovation into access for ATMPs (15/11/2024)

The EU-Innovation Network (EU-IN) and the Italian Medicines Agency (AIFA) are organising a multi-stakeholder meeting to discuss how innovation in the development of Advanced Therapy Medicinal Products (ATMPs) can be translated into effective and safe therapies at the point of care in Europe.

Recent events (02/10/2024)

Recent events

European Shortages Monitoring Platform (26/05/2024)

The EMA is setting up the European Shortages Monitoring Platform (ESMP) to gather information about medicine supply and demand to prevent, detect, and manage human medicine shortages in the European Union and European Economic Area. The first version of the platform will be available by February 2025. A dedicated webinar is organised on 24 June 2024 for Marketing Authorisation Holders in the EU/EEA.

SME survey (28/05/2024)

The SME office is conducting a survey to receive feedback from stakeholders on the support, services and incentives provided to SMEs by EMA. It will allow the SME office to better understand current issues faced by SMEs and will help tailor future activities to the needs of SMEs. We invite you to contribute to the survey by 12 July 2024.

SME office annual reports (26/05/2024)

The 2023 annual report of the SME office has been published, highlighting sustained high figures of SMEs registered with EMA, an increase in SME briefing meetings and higher success rate for marketing authorisation applications for human medicines.

Critical medicines (28/05/2024)

EMA has published recommendations developed by the Medicines Shortages Steering Group (MSSG) to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.

The following documents for human and veterinary medicines were released for consultation: (27/05/2024)

The following documents for human and veterinary medicines were released for consultation:

The following documents for human and veterinary medicines were also published: (27/05/2024)

The following documents for human and veterinary medicines were also published:

Medical devices (27/05/2024)

A questions and answers document on the implementation of the medical devices and the in vitro diagnostics regulations for combinations of medicinal products and medical devices has been revised based on experience gained since the implementation of the new regulations.

Clinical Trials Information System (CTIS) (23/05/2024)

Revised CTIS transparency rules applicable as from 18 June 2024 introduce simplifications to provide access to clinical trial information in a faster and more efficient way. A key change is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents to protect commercially confidential information (CCI).

CTIS guidance and training on transitioning trials (23/05/2024)

Updated guidance and training material for sponsors transitioning trials from EudraCT to CTIS is available on the CTIS website, under a section “Transitioning Trials”.

ACT EU Multi-stakeholder platform (13/02/2024)

The ACT EU Multi-stakeholder platform (MSP) was launched on 20 March 2024. It provides a platform for stakeholders to exchange views on aspects of clinical research including clinical trials regulation, methodologies, and technology.

Pilot projects for clinical trials (23/05/2024)

ACT EU is launching two pilot projects offering:

Real world data (27/05/2024)

New HMA-EMA catalogues of real-world data (RWD) sources, studies, institutions and networks were launched on 15 February 2024. The catalogues are repositories of metadata collected from RWD sources and studies intended to help regulators, pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

Guidance on real-world evidence (26/05/2024)

A document on how EMA provides real-word evidence by analysing real-word data in the context of regulatory decision-making has been published.

Darwin EU (27/05/2024)

The Data Analysis and Real-World Interrogation Network (DARWIN EU) continues working towards higher capacity for real-world data studies and seeks to add new data partners in 2024 and 2025. Results from DARWIN studies are publicly available in the new HMA-EMA Catalogue of RWD studies.

SoHO Regulation (13/02/2024)

On 24 April 2024, the European Parliament approved a new regulation on standards of quality and safety for substances of human origin intended for human application (SoHO). The new rules will strengthen levels of health protection for these substances, improve harmonisation across the EU, facilitate innovation through common EU-wide authorisation procedures and advice on the regulatory status of a substance. It will also allow data reporting and information sharing on supply, quality and safety on SoHO via a common IT platform. The Council will now formally adopt the new regulation which will apply as from mid-2027.

One Health (27/05/2024)

An EU agencies task force including ECDC, ECHA, EEA, EFSA and EMA has been established to implement a joint framework for action on ‘One Health’ over 2024-2026. It aims to prevent and respond to health threats and focuses on strategic objectives to ensure that scientific advice provided by the agencies is increasingly integrated and that they can contribute with a common voice to the One Health agenda in the EU.

Human medicines (26/05/2024)

Human medicines

Veterinary Medicines (27/05/2024)

Veterinary Medicines

Joint HMA-EMA workshop on Real World Evidence methods (14/06/2024)

The workshop will engage with stakeholders and experts on the draft RWE reflection paper released for public consultation in May 2024 and on priorities for further regulatory guidance development and collaboration.

New Fee Regulation: webinar for veterinary Marketing Authorisation Holders (20/06/2024)

The Agency invites all veterinary Industry Marketing Authorisation Holders to an introductory webinar on the upcoming changes resulting from the new fee regulation (Regulation (EU) 2024/568).

European Shortages Monitoring Platform Essentials and Industry Reporting Requirements (24/06/2024)

The European Shortages Monitoring Platform (ESMP) Essentials and Industry Reporting Requirements Webinar aims to provide an overview of the ESMP and the information that will be reported through it by the pharmaceutical industry once it is operational.

Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal (20/06/2024)

This bitesize talk will provide an opportunity for sponsors to familiarise themselves with the revised transparency rules that will become applicable on 18 June 2024 and with the new CTIS Public portal that will go live as of 18 June 2024.

EMA workshop on challenges in drug development, regulation and clinical practice in hemoglobinopathies (01/07/2024)

This workshop is organised in order to receive a multi-stakeholder’s perspectives on sickle disease and thalassaemia before initiating the drafting of new guidelines.

SPOR Status Update (10/07/2024)

EMA is organising a public webinar on Substance, Product, Organisation, Referentials (SPOR) Regulatory Data Management (RDM) services status update.

Recent events (23/05/2024)

Recent events

Editorial (09/02/2024)

Welcome to the first edition of the SME newsletter for 2024. We are excited to bring you the latest updates and information on matters relevant to Small and Medium-sized Enterprises. Our goal is to provide valuable insights into regulatory and scientific topics, public consultations, and events that may be of interest to your business.

Major update of the SME user guide (09/02/2024)

The SME user guide provides information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. The new release includes updates to reflect changes in the EU’s legal and regulatory framework for human and veterinary medicines.

Union list of critical medicines (13/02/2024)

The European Commission, the Heads of Medicines Agencies and EMA have released the Union list of critical medicines in order to ensure supply security and prevent shortages of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority.

ACT EU workplan for 2023-2026 (13/02/2024)

A second HMA-EC-EMA ACT EU workplan setting out deliverables and timelines for the programme was published. It highlights key focus areas to further facilitate innovation in clinical trials, stakeholder engagement and regulatory network collaboration.

CTIS transparency rules (13/02/2024)

Revised CTIS transparency rules adopted on 5 October 2023 introduced simplifications to give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way and remove the deferral mechanism to deliver earlier publication of key documents and protocols, as well as system simplification.

Transition of clinical trials to the Clinical Trials Regulation (13/02/2024)

All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 30 January 2025. The deadline date will mark the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.

Other news on clinical trials (13/02/2024)

The following documents have been updated:

Quality guidelines (13/02/2024)

Quality guidelines

Clinical guidelines (13/02/2024)

Clinical guidelines

Medical Devices (13/02/2024)

Medical Devices

Artificial intelligence workplan (13/02/2024)

EMA and the Heads of Medicines Agencies (HMAs) have published a workplan on artificial intelligence to 2028, which sets out a strategy to guide the use of AI in medicines regulation and focuses on the following key areas: guidance, policy and product support, AI tools and technology, collaboration and training, and experimentation.

Invented names (13/02/2024)

Invented names

IRIS for human and veterinary regulatory procedures (13/02/2024)

IRIS

Standard for the Exchange of Nonclinical Data (SEND) proof of concept study (13/02/2024)

SEND

Veterinary medicines (13/02/2024)

New guidelines on the calculation of dose factor to be submitted to the Union Product Database and on the assessment criteria to determine the need for an MRL evaluation for chemical-unlike biological substances were published. Several draft guidelines were also released for consultation on topics such as GMP for active pharmaceutical ingredients and benefit risk evaluation.

Webinar on the HMA-EMA Catalogues of real-world data sources and studies (04/03/2024)

This event provides an overview of the HMA-EMA Catalogues of real-world data sources and studies including their benefits and significance in regulatory practices. It will also explain how to use the catalogues, user roles and responsibilities effectively.

Clinical Trials Information System (CTIS): Walk-in clinic (12/03/2024)

The walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical advice on the Clinical Trials Information System by asking questions to CTIS experts.

Veterinary Medicines Info Day 2024 (14/03/2024)

EMA is organising the annual Veterinary Medicines Info Day to provide updates on regulatory policy, scientific and legislative developments for veterinary medicines.

Clinical Trials Information System Webinar: Last Year of Transition (25/03/2024)

The event will provide reflection on the implementation of the Clinical Trials Regulation, transitional trials and how they are updated in CTIS and update on the current status of CTIS.

Cancer Medicines Forum workshop (05/04/2024)

EMA and the European Organisation for Research and Treatment of Cancer (EORTC) are co-chairing the Cancer Medicines Forum which aims to integrate the work of the academic sector into the regulatory decision-making process. The workshop will discuss challenges and solutions with regards to treatment optimisation taking into consideration the ICH E9(R1) guidance.

EMA multi-stakeholder workshop on psychedelics (16/04/2024)

The workshop will bring together patients, healthcare professionals, academia, regulators, and industry to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.

Recent events (13/02/2024)

Recent events