Cluster activities

The European Medicines Agency (EMA) holds regular meetings with other non-EU regulators in so-called 'clusters'. The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.

Cluster meetings are structured, collaborative forums that support the exchange of information on medicines throughout their lifecycle. 

They bring together the European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), and other international regulatory partners operating under working arrangements. For more information on the working arrangements EMA has with other authorities, see International arrangements.

The clusters strengthen mutual understanding of regulatory practices among regulatory partners and help address common challenges. They also support greater convergence and harmonisation of regulatory decision-making, including the development of guidelines and reflection papers.

Other activities promoted under this cooperation model that enable knowledge sharing include workshops, training sessions, webinars and joint publications.

More details on the activities of all clusters are available under 'Cluster overview' on this page. The clusters are listed in alphabetic order.

Cluster overview

The clusters focus on specific topics, such as:

• Therapeutic areas
• Product types
• Scientific methods
• Inspections
• Cross-cutting regulatory issues

Select the expandable panels available below to learn more about the objectives and activities of each clusters, including related terms of reference.

The clusters are listed in alphabetic order.

Advanced therapy medicinal products

The table below provides at-a-glance information on when the advanced therapy medicinal products cluster was established, its meeting frequency and participation:

Established	2008
Meeting frequency	Every two months
Participants	EMA, US FDA, Health Canada, PMDA, Swissmedic

The main objective of this cluster is to exchange scientific and regulatory knowledge on the development, evaluation and post-authorisation monitoring of advanced therapy medicinal products (ATMPs). 

Examples of ATMPs include gene therapies, cell therapies, and tissue-engineered products.

The discussions of this cluster focus on the following:

• Manufacturing aspects
• Clinical trial design
• Clinical safety evaluation
• Labelling
• Post-authorisation monitoring of safety and effectiveness

The ATMPs cluster also provides a forum for discussing novel regulatory approaches for ATMPs, and for supporting regulatory convergence and harmonisation.

It collaborates regularly with other clusters, including those focused on rare diseases, oncology, and paediatric medicines. This reflects the multidisciplinary nature of ATMPs development.

The EMA's Committee for Advanced Therapies (CAT) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the advanced therapy medicinal products cluster

For more information, see:

• Advanced therapy medicinal products: Overview
• Committee for Advanced Therapies (CAT)

Anti-infectives and antimicrobial resistance

The table below provides at-a-glance information on when the anti-infectives and antimicrobial resistance cluster was established, its meeting frequency and participation:

Established	2010
Meeting frequency	Every quarter
Participants	EMA, US FDA, Health Canada, PMDA

The main objective of this cluster is to foster a consistent global approach to the development of anti-infective medicines across regulatory jurisdictions. It aims to harmonise regulatory expectations for marketing authorisation.

The cluster builds a shared understanding of each participating agency's regulatory approach to the development of anti-infective medicines, based on internal policies and guidance.

It also provides a forum for discussing candidate anti-infectives, supporting patient access to antimicrobial treatments and helping to combat antimicrobial resistance.

The EMA's Emergency Task Force (ETF) and the Infectious Diseases Working Party (IDWP) support the work of this cluster.

The terms of reference document is currently under revision.

For more information, see:

• Emergency Task Force (ETF)
• Infectious Diseases Working Party (IDWP)
• Antimicrobial resistance

Antivirals

The table below provides at-a-glance information on the antiviral cluster's meeting frequency and participation:

Meeting frequency	Every quarter
Participants	EMA, US FDA

This cluster aims to promote a harmonised global regulatory framework for antivirals development. It is a collaboration between EMA and US FDA.

The objectives of this cluster are:

• Exchange information
• Discuss key aspects of antiviral product development for the prevention or treatment of viral infections - including HIV, respiratory viruses, hepatitis, herpes viruses and emerging threats
• Review each agency’s scientific advice on investigational and approved antivirals

This cluster also aims to share insights on post‑marketing safety or efficacy concerns, and provide the scientific basis for regulatory decision‑making.

The EMA's Infectious Diseases Working Party (IDWP) supports the work of the antiviral cluster.

More information on the work of this cluster is available in the terms of reference below:

Antivirals cluster – Terms of Reference

For more information, see:

• Infectious Diseases Working Party (IDWP)

Active pharmaceutical ingredient (API) programme

The table below provides at-a-glance information on when the active pharmaceutical ingredient (API) programme cluster was established, its meeting frequency and participation:

Established	2011, with a preparatory pilot between 2008 and 2010
Meeting frequency	Every two months
Participants	EMA and European Economic Area (EEA) individual national competent authorities, European Commission, US FDA, TGA, ANVISA, Health Canada, PMDA, MHRA, EDQM, WHO

This cluster provides a platform for participating regulatory authorities and organisations to coordinate international good manufacturing practice (GMP) inspections of API manufacturers, building on mutual confidence and common standards.

The reference GMP standard for inspections is ICH Q7 Good manufacturing practice for active pharmaceutical ingredients.

The main objective of this collaboration is to strengthen international cooperation and information sharing. This allows a more efficient use of inspection capacity - with more sites monitored, improved oversight, and reduced duplication of efforts.

Participating regulatory authorities and organisations support the work of this cluster by sharing inspection plans and outcomes.

For more information, see the documents available below - including its terms of reference. The document is currently under revision.

Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use - Terms of reference for participating authorities

Reference Number: EMA/INS/GMP/644249/2019

Report on the International Active Pharmaceutical Ingredient Inspection Programme 2011-2016

Bioequivalence

The table below provides at-a-glance information on when the bioequivalence cluster was established, its meeting frequency and participation:

Established	2014
Meeting frequency	Every quarter
Participants	EMA and individual European Economic Area (EEA) national competent authorities, US FDA

This cluster supports EMA and US FDA cooperation on inspections of facilities conducting bioequivalence studies. This supports the application of marketing authorisation for generic medicines.

The joint inspections may take place worldwide, beyond the European Union (EU) and / or United States.

This cluster brings together EU Member States to cover both nationally and centrally authorised products. This is because EMA has a limited role in the generics field.

It is linked to the good clinical practice (GCP) initiative and aims to:

• Facilitate the exchange of information on inspections of bioequivalence studies - including information on clinical and analytical facilities
• Provide training opportunities to strengthen and improve the quality and consistency of bioequivalence inspections

For more information on the work of this cluster, see its terms of reference below. The document is currently under revision.

EMA-EU MSs-FDA initiative on inspections for Generic Applications: Terms of engagement and procedures for participating authorities

Reference Number: EMA/INS/GCP/644751/2012

For more information, see

• Good clinical practice

Biosimilars

The table below provides at-a-glance information on when the biosimilars cluster was established, its meeting frequency and participation:

Established	2011
Meeting frequency	Every six months
Participants	EMA, US FDA, Health Canada, PMDA, Swissmedic

The cluster provides a platform for discussing candidate biosimilar products, including:

• Regulatory pathways
• Quality and clinical evidence to support development programs
• Pharmacokinetics and pharmacodynamics evaluation
• Clinical efficacy and safety evaluation
• Quality evaluation - analytical and functional comparability
• Labelling aspects
• Post-marketing monitoring of biosimilar products safety and effectiveness
• Issues related to manufacturing process and controls, as needed

This cluster’s main objective is to establish a shared understanding of each participating agency’s regulatory approach to biosimilar development. It draws on internal policies, guidance, and regulations.

The EMA's Biosimilar Medicinal Products Working Party (BMWP) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for biosimilars cluster

For more information, see:

• Biosimilar Medicinal Products Working Party (BMWP)
• Multidisciplinary guidelines: biosimilar

Biostatistics

The table below provides at-a-glance information on when the biostatistics cluster was established, its meeting frequency and participation:

Established	2011
Meeting frequency	Every six months
Participants	EMA, US FDA, PMDA

This cluster’s primary goal is to allow a platform for statisticians from participating agencies to exchange knowledge and experience. It also enables discussions on emerging biostatistics issues in medical product development.

In addition, it helps support regulatory coordination and transparency.

Its main objectives:

• Facilitate regular exchange of knowledge and experience related to important emerging biostatistics issues in medical product development
• Discuss challenging biostatistics topics and foster global harmonisation in areas important for the development of safe and effective medical products
• Understand the scientific rationale when regulatory agencies have different opinions on important biostatistics issues

The biostatistics special interest area of the Methodology European Specialised Expert Community supports the work of this cluster. This includes members of the EMA's Methodology Working Party.

This cluster complements the work of clinical clusters that focus on the clinical and statistical issues of clinical assessment and review.

More information on the work of this cluster is available in the terms of reference below:

Biostatistics cluster – Terms of Reference

For more information, see:

• Methodology European Specialised Expert Community
• Methodology Working Party
• Biostatistics guidelines
• ICH E9 statistical principles for clinical trials - Scientific guideline
• ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Scientific guideline
• ICH E20 adaptive designs for clinical trials - Scientific guideline
• ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline

Blood products

The table below provides at-a-glance information on when the blood product cluster was established, its meeting frequency and participation:

Established	2010
Meeting frequency:	Every quarter
Participants	EMA, US FDA, Health Canada

The primary goal of this cluster is to share scientific aspects of development, evaluation, and post-marketing impacting blood products that the participating agencies regulate.

Cluster discussions focus on the following:

• Regulatory pathways
• Non-clinical evidence needed to support development programs
• Clinical trial design and safety evaluation
• Labelling considerations
• Post‑marketing aspects
• Issues related to manufacturing processes and controls, when relevant

This cluster supports global dialogue on blood products by addressing emerging issues and sharing reports confidentially. It aims to achieve a harmonised view between EMA, US FDA and Health Canada.

The EMA's Haematology Working Party (HAEMWP) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the European Medicines Agency, Health Canada and United States Food and Drug Administration cluster on blood products

For more information, see:

• Haematology Working Party
• Scientific article - The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative

Cardiovascular products

The table below provides at-a-glance information on when the cardiovascular product cluster was established, its meeting frequency and participation:

Established	2011
Meeting frequency	Every quarter
Participants	EMA, US FDA, Health Canada, PMDA, Swissmedic

The main goal of this cluster is to share scientific insights on the development of medicines for cardiovascular diseases.

It aims to build a shared understanding of each participating agency’s regulatory approach to the development of cardiovascular products. It does so by drawing on internal policies, guidance, and regulations. 

It facilitates discussions on key aspects of candidate medicinal product evaluation. This includes:

• Trial endpoints
• Safety populations
• Statistical approaches
• Post‑marketing methodologies
• Pre‑clinical evidence requirements 

This cluster also offers a forum for exchange of draft documents, guidelines in development, and more detailed information supporting the scientific basis for decision-making. It also discusses post‑marketing topics for cardiovascular products. This includes emerging safety concerns and extension applications.

The EMA's Cardiovascular Working Party supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below. The document is currently under revision.

Terms of reference for the European Medicines Agency and United States Food and Drugs Administration cardiovascular cluster

For more information, see:

• Cardiovascular Working Party

Good clinical practice (GCP)

The table below provides at-a-glance information on when the good clinical practice (GCP) cluster was established, its meeting frequency and participation:

Established	2010, with a preparatory pilot started in 2009
Meeting frequency	Every two months
Participants	EMA, US FDA, PMDA

Regulatory collaboration supports the efficient use of GCP inspection capacity.

Regulatory authorities benefit from information sharing and coordinated approaches, which enable more effective regulatory oversight.

The initiative aims to:

• Conduct periodic exchanges of GCP‑related information
• Improve inspection planning through better‑informed site and study selection
• Share relevant GCP inspections data
• Foster timely communication regarding inspection outcomes of common interest

In addition, the initiative includes:

• Conducting collaborative GCP inspections to build mutual understanding and confidence in each participating authority’s inspection processes
• Enhancing the effectiveness of inspections through shared best practices
• Exchanging information on GCP interpretation - including legislation, guidance, policies, and areas where further convergence would benefit clinical research

The terms of reference document is currently under revision.

For more information, see:

• Good clinical practice

Generics

The table below provides at-a-glance information on when the generics cluster was established, its meeting frequency and participation:

Established	2021
Meeting frequency	Every quarter
Participants	EMA, US FDA, TGA, Health Canada, MOH, Swissmedic, MHRA

This cluster brings together regulatory agencies worldwide to share knowledge, address common challenges, and advance best practices in generic medicines. 

It supports efficient regulation and timely access to high-quality generic medicines for patients.

This cluster aims to:

• Facilitate timely exchange of information on policies under development - such as drafting guidance
• Promote a common understanding of participating agencies’ regulatory requirements for the approval of generic medicines
• Encourage the harmonisation of approaches 

The EMA's Clinical Pharmacology Operational Expert Group supports the work of this cluster on bioequivalence aspects.

The terms of reference document is currently under revision.

For more information, see:

• Clinical Pharmacology Operational Expert Group

Drug Shortages Global Regulatory Working Group

The table below provides at-a-glance information on the Drug Shortages Global Regulatory Working Group cluster's meeting frequency and participation:

Meeting frequency	Every quarter
Participants	EMA, US FDA, TGA, Health Canada, MHLW, DHSC and MHRA, WHO

This cluster aims to strengthen international collaboration in preventing and responding to medicine shortages with a global impact. 

It does so through the following activities:

• Enhancing transparency and communication among regulatory authorities
• Identifying opportunities for international alignment and coordination of actions to prevent and mitigate medicines’ shortages, where appropriate
• Discussing policy measures and best practices to address shortages

The terms of reference document is currently under revision.

For more information, see:

• Drug Shortages Global Regulatory Working Group

International Medicines Regulators Working Group on 3Rs

The table below provides at-a-glance information on when the International Medicines Regulators Working Group on 3Rs cluster was established, its meeting frequency and participation:

Established	2024
Meeting frequency	Every quarter
Participants	EMA, US FDA, TGA, Health Canada, PMDA, Swissmedic

The International Medicines Regulators’ Working Group on 3Rs aims to foster a consistent global approach across regulatory jurisdictions by:

• Establishing internationally harmonised 3Rs (replacement, reduction, refinement) recommendations
• Supporting the implementation of new alternative approaches for testing of human and veterinary medicinal products

This group is a collaborative forum that facilitates discussion on the harmonised application of the 3Rs, including:

• Agreeing on the regulatory acceptance of new approach methodologies (NAMs) - which aims to reduce or replace animal testing in medicines development
• Reviewing quality control and batch release requirements in order to encourage broader acceptance of the use of 3Rs-compliant methods
• Phasing out of obsolete animal tests
• Sharing information, training, competence building and stakeholder engagement on 3Rs topics

The EMA's 3Rs Working Party supports the work of this cluster.

For more information on the work of this cluster, see its terms of reference below. The document is currently under revision.

Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs

Reference Number: EMA/27380/2024

To learn more, see:

• 3Rs Working Party
• Ethical use of animals in medicine testing
• Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing

Neuroscience

The table below provides at-a-glance information on when the neuroscience cluster was established, its meeting frequency and participation:

Established	2018
Meeting frequency	Every month
Participants	EMA, US FDA

The neuroscience cluster provides a confidential forum supporting the development of medicines for neurological and psychiatric disorders.

This cluster aims to:

• Exchange information on the scientific evaluation of marketing applications for neurologic and psychiatric medicinal products within the regulatory scope of EMA and the FDA
• Share relevant policy documents, guidance, and legislation affecting neuroscience product development and assessment
• Exchange views on regulatory impacts, priorities, and emerging areas of mutual interest

In addition, it aims to identify and pursue mutually beneficial activities such as joint scientific symposia or workshops. These events aim to advance regulatory science and promote the sharing of experiences, lessons learned, and best practices. This includes evaluating novel endpoints, biomarkers, clinical trial designs, and new therapeutic modalities in neuroscience.

The EMA's Central Nervous System Working Party supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Neuroscience Cluster – Terms of Reference

For more information, see:

• Central Nervous System Working Party 

Non-clinical oncology

The table below provides at-a-glance information on when the non-clinical oncology cluster was established, its meeting frequency and participation:

Established	2014
Meeting frequency	Every quarter
Participants	EMA, US FDA

This cluster aims to:

• Share best practices across participating agencies throughout the regulatory lifecycle of oncology medicines
• Strengthen non‑clinical review of applications

Its key areas include:

• Non‑clinical aspects of products under marketing review
• Non‑clinical considerations for investigational products
• Review of medicines and biologics generally covered by ICH S9 and related Q&A

The cluster also works to:

• Harmonise interpretations of ICH S9 and relevant EMA and FDA guidance documents
• Explore general approaches - such as requirements for proof of concept, toxicology programmes, DART or carcinogenicity studies for oncology products
• Promote streamlined non‑clinical development in oncology

In addition, it addresses non‑clinical approaches to products for benign (non‑malignant) tumours. Moreover, it supports the application of the 3Rs principles when considering relevant topics.

The EMA's Non-clinical Working Party supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of Reference for the Non-Clinical Oncology European Medicines Agency and United States Food and Drug Administration Cluster

For more information, see:

• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals - Scientific guideline
• Ethical use of animals in medicine testing
• Non-clinical Working Party

Oncology early dialogue

The table below provides at-a-glance information on when the oncology early dialogue cluster was established, its meeting frequency and participation:

Established	2025
Meeting frequency	Every month
Participants	EMA, US FDA

This cluster provides a forum for early regulatory dialogue and information sharing on oncology products - during EMA's scientific advice and pre-authorisation phases and the US FDA's investigational new drug phase and beyond.

This cluster aims to:

• Exchange information on the development, evaluation, and post-marketing oversight of oncology products within the regulatory scope of the EMA and US FDA
• Discuss scientific and regulatory issues related to specific products and medicine classes
• Share perspectives on data interpretation, clinical study design, data extrapolation, regulatory requirements, labelling, and risk management
• Exchange views on emerging scientific and regulatory challenges affecting oncology product development

In addition, this cluster supports global development of clinical trials. Moreover, it promotes early regulatory alignment and consistent feedback to sponsors throughout product development.

The EMA's Scientific Advise Working Party supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for European Medicines Agency and United States Food and Drug Admnistration oncology early-dialogue cluster

For more information, see:

• Scientific Advise Working Party

Oncology-haematology medicinal products

The table below provides at-a-glance information on when the oncology-heamatology medicinal products cluster was established, its meeting frequency and participation:

Established	2004
Meeting frequency	Every month
Participants	EMA, US FDA, TGA, Health Canada, PMDA, Swissmedic

This cluster aims to discuss scientific issues related to the evaluation of medicines that the participating agencies regulate. 

Related areas include:

• Clinical study design
• Endpoints
• Dosing
• Pharmacokinetics aspects
• Safety considerations

This cluster also aims to foster a common understanding of each participating agency’s regulatory approach to product development for these conditions. In doing so, it draws on internal policies, guidance documents, and regulations. 

In addition, it addresses emerging issues and facilitates global discussions on novel oncology products. Moreover, it provides a forum for discussing policies under development and guidance. 

These exchanges support regulatory decision-making and foster understanding of the perspectives of different health authorities.

The EMA's Oncology Working Party supports the work of this cluster.

The terms of reference document is currently under revision.

For more information, see:

• Oncology Working Party

Orphan medicinal products

The table below provides at-a-glance information on when the orphan medicinal products cluster was established, its meeting frequency and participation:

Established	2008
Meeting frequency	Every quarter
Participants	EMA, US FDA

The main goal of this cluster is to share experiences and decisions setting a precedence for granting orphan designations in the United States and Europe. 

This cluster aims to develop a shared understanding of each participating agency’s regulatory approaches to orphan designation. This is informed by internal policies, guidance documents, and regulations. 

It provides a forum to discuss key aspects of orphan designation, including:

• Regulatory flexibility
• Designation criteria - definition of the condition, scientific plausibility, prevalence, and major contribution to patient care
• Operation of incentives
• Legal challenges to designation decisions
• Paediatric considerations
• Issues related to orphan similarity or sameness

In addition, discussions also cover the following areas:

• Guidance
• Communications
• New procedures
• Role of patient advocates
• Legislative changes
• Grant systems that enhance the development and availability of treatments for rare diseases

The EMA's Committee for Orphan Medicinal Products (COMP) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the European Medicines Agency and the United States Food and Drugs Administration cluster on orphan medicinal products

For more information, see:

• Committee for Orphan Medicinal Products (COMP)

Patient engagement

The table below provides at-a-glance information on when the patient engagement cluster was established, its meeting frequency and participation:

Established	2016
Meeting frequency	Every four to six months
Participants	EMA, US FDA, Health Canada

This cluster aims to share best practices for involving patients along the medicine’s regulatory lifecycle within the participating agencies.

It focuses on the following:

• Providing a forum to discuss broad topics of relevance to patients and their organisations
• Strengthening patient engagement throughout medicine development, evaluation and post‑authorisation activities
• Sharing approaches designed to enhance engagement, including the different methodologies used to involve patients in regulatory work
• Facilitating the exchange of information - on internal policies, guidance documents, and regulations, as well as topics of mutual interest that may attract significant public attention and require coordinated communication

It also provides a forum to discuss future priorities and proposals to advance engagement efforts, as well as to share experiences on related challenges.

The EMA's Patients’ and Consumers’ Working Party (PCWP) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the European Medicines Agency, United States Food and Drugs Administration and Health Canada cluster on patient engagement

For more information, see:

• Patients’ and Consumers’ Working Party
• Patients' and Consumers' Working Party meetings
• Scientific article - Engaging patients in medicines regulation: a tale of two agencies

Paediatric medicinal products

The table below provides at-a-glance information on when the paediatric medicinal product cluster was established, its meeting frequency and participation:

Established	2007
Meeting frequency	Every month
Participants	EMA, US FDA, TGA, Health Canada, PMDA, Swissmedic

The main goal of this cluster is to support global development plans for paediatric medicinal products. It also looks to discuss issues that arise during the regulatory lifecycle.

This cluster aims to facilitate regular exchange of information on scientific and ethical issues in paediatric product development programs submitted to participating regulatory agencies. This helps avoid unnecessary or duplicative trials in children.

The information exchanged between authorities includes:

• Paediatric investigation plans that EMA produces
• Pediatric study plans and proposed pediatric study requests that the US FDA produces

The relevant cluster subject matter experts may agree on high-level action items and share them with the applicant, company, or sponsor.

This cluster also provides a forum to discuss post‑marketing paediatric requirements, including risk management and long‑term safety monitoring.

The participating agencies may prepare a common commentary for the applicant, company, or sponsor - when it is helpful to convey their opinions on specific paediatric medicinal product development plans. These include:

• Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])
• Common commentary on paediatric oncology drug development published: another step in optimising global regulatory coordination of paediatric development plans

The agencies can also establish joint working groups and workshops when they require extended in-depth discussions on specific therapeutic areas.

The EMA's Paediatric Committee (PDCO) and related working parties and operational expert groups support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Pediatric cluster terms of reference

For more information, see:

• PDCO: Working parties and other groups
• Pediatric Medicine Development: An overview and comparison of regulatory processes in the European Union and United States
• Accelerating the global development of pediatric cancer drugs: A call to coordinate the submissions of pediatric investigation plans and pediatric study plans to the European Medicines Agency and US Food and Drug Administration
• New strategies for the conduct of clinical trials in pediatric pulmonary arterial hypertension: Outcome of a multistakeholder meeting with patients, academia, industry, and regulators, held at the European Medicines Agency on Monday, June 12, 2017
• Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration - Scientific guideline

Pharmacometrics

The table below provides at-a-glance information on when the pharmacometrics cluster was established, its meeting frequency and participation:

Established	2016
Meeting frequency	Every quarter
Participants	EMA, US FDA, TGA, Health Canada, PMDA

The goal of this cluster is to foster collaboration and scientific exchange among the participating regulatory agencies. This supports their discussion on best practices and product development matters.

It aims to exchange information and perspectives on pharmacometrics. This includes guidelines, workshops, publications and products under parallel assessment. 

The participating agencies also work together to harmonise their practices and activities in this area.

The EMA's Methodology Working Party supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Pharmacometrics cluster – Terms of Reference

For more information, see:

• Methodology Working Party 

Pharmacovigilance

The table below provides at-a-glance information on when the pharmacovigilance cluster was established, its meeting frequency and participation:

Established	2013
Meeting frequency	Every month
Participants	EMA, US FDA, Health Canada, PMDA

This cluster allows participating regulatory authorities to share information on risk assessments, especially emerging safety concerns.

It aims to provide participants with advance notice of anticipated regulatory actions and communications, preceeding related decisions and public announcements.

This cluster's activities include the following:

• Facilitating the exchange of information - on policies, guidance documents, and regulations, as well as concerns related to pharmacovigilance systems and inspection findings
• Providing a platform to discuss the impacts, priorities, and goals of pharmacovigilance activities - especially in areas of emerging science of mutual interest
• Identifying activities of mutual benefit which support the ongoing improvement of pharmacovigilance activities - such as jointly sponsored scientific symposia

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) supports the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Pharmacovigilance cluster – Terms of Reference

For more information, see:

• Pharmacovigilance Risk Assessment Committee (PRAC)
• Pharmacovigilance: Overview

Artificial intelligence (AI) in pharmacovigilance

The table below provides at-a-glance information on when the artificial intelligence (AI) in pharmacovigilance cluster was established, its meeting frequency and participation:

Established	2023
Meeting frequency	Every quarter
Participants	EMA, US FDA, Health Canada, PMDA

This cluster aims to facilitate the exchange of information, and explore alignment and collaboration on various aspects of the use of AI in pharmacovigilance. 

It is a platform where participants share their experience on the development and implementation of AI systems to support pharmacovigilance processes within their respective organisations. This includes identifying areas where more research is needed and / or collaboration would be beneficial.

This cluster also provides a forum to share perspectives and approaches on relevant policies and guidance development.

More information on the work of this cluster is available in the terms of reference below:

Guiding principles for the EMA - US FDA cluster teleconferences on Artificial Intelligence in Pharmacovigilance

Reference Number: EMA/422032/2023

For more information, see:

• Artificial intelligence

Pregnancy and breastfeeding

The table below provides at-a-glance information on when the pregnancy and breastfeeding cluster was established, its meeting frequency and participation:

Established	2020
Meeting frequency	Every quarter
Participants	EMA, US FDA, Health Canada, PMDA, MHRA

This cluster aims to promote a harmonised and consistent global approach across regulatory jurisdictions. This is to ensure evidence-based safe and effective use of medicines during pregnancy and breastfeeding.

It enables engagement in product‑specific as well as strategic discussions on certain topics, such as:

• Strategies for data collection
• Clinical trial design
• Data interpretation
• Risk management - including labelling, signal detection methods, and post-authorisation studies

In addition, this cluster includes the following activities:

• Sharing best practices that address ethical, scientific, and regulatory barriers - to improve clinical trial inclusion of pregnant and breastfeeding individuals, as well as those who may become pregnant
• Encouraging early, aligned, and consistent engagement with sponsors during product development and after approval
• Fostering robust non‑clinical and clinical investigations in these populations - such as the use of novel trial designs, clinical pharmacology studies, and advanced statistical methods
• Establishing best practices for identifying products where early exploration of use in pregnancy or breastfeeding is essential

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) are frequently invited to these cluster meetings.

More information on the work of this cluster is available in the terms of reference below. The document is currently under revision.

Terms of reference for the cluster on pregnancy and lactation

For more information, see:

• Report - Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
• ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline
• Medicines during pregnancy and breastfeeding
• Podcast Inside EMA - Evidence for two: medicines in pregnancy and breastfeeding

Rare diseases

The table below provides at-a-glance information on when the rare diseases cluster was established, its meeting frequency and participation:

Established	2016
Meeting frequency	Every month
Participants	EMA, US FDA, Health Canada

The primary goal of this cluster is to discuss the scientific evaluation of medicine development for rare diseases in order to identify common and differing perspectives across participating agencies. 

This is particularly valuable for accelerated approval (US FDA), conditional or exceptional approval (EMA), breakthrough designation (US FDA), and PRIME designation (EMA).

This cluster aims to promote a common understanding of each participating agency’s regulatory approach to the development of medicines for rare diseases. It does so by drawing on internal policies, guidance documents, and regulations.

It provides a forum for discussing candidate products for rare diseases, including:

• Regulatory flexibility
• Trial endpoints
• Safety populations
• Statistical approaches for small and heterogeneous populations
• Post‑marketing methodologies
• Pre‑clinical evidence requirements
• Issues related to chemistry, manufacturing, and controls, when needed

In addition, this cluster seeks to address long-term safety concerns for therapies developed for rare diseases. Moreover, it strengthens the global safety net by enabling confidential sharing of safety reports and regulatory insights.

The EMA's Committee for Orphan Medicinal Products (COMP) and its related working groups support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the rare diseases cluster

For more information, see:

• Committee for Orphan Medicinal Products (COMP)

• PRIME: priority medicines

Real-world evidence (RWE)

The table below provides at-a-glance information on when the real-world evidence (RWE) cluster was established, its meeting frequency and participation:

Established	2018
Meeting frequency	Every month
Participants	EMA, US FDA, Health Canada

The main goal of this cluster is to share experience and lessons gained from generating and assessing of real-world evidence derived from the analysis of real-world data (RWD). This helps support regulatory decision-making.

The cluster aims to:

• Strengthen collaboration on scientific and regulatory guidance for RWD collection, transformation, and analysis - by focusing on methodologies for regulatory use cases where experience with RWE is still limited
• Sharing knowledge on specific data sources, networks or projects where collaboration could add value for RWE generation and use - this is in the context of evaluating the effectiveness and safety of medicines
• Exploring opportunities for regulatory convergence through the development of shared principles and international standards on the generation and use of RWE for regulatory decision-making

Members of EMA's Methodology Working Party with expertise in pharmacoepidemiology support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the European Medicines Agency – United States Food and Drugs Administration – Health Canada cluster on real world data

For more information, see:

• Real-world evidence
• Data quality framework for medicines regulation
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E23: Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M14: Use of real-world data for safety assessment of medicines
• Scientific publication: Collaborative Real-World Evidence Among Regulators: Lessons and Perspectives
• Methodology Working Party

Vaccines

The table below provides at-a-glance information on when the vaccines cluster was established, its meeting frequency and participation:

Established	2005
Meeting frequency	Every quarter
Participants	EMA, US FDA, TGA, Health Canada

This cluster aims to achieve the following objectives:

• Share information on the scientific evaluation of vaccines against infectious diseases
• Address emerging issues
• Promote global discussion on new vaccines - including those developed to prevent emerging pathogens

Discussions cover the following areas:

• Regulatory pathways
• Pre-clinical evidence to support development programs
• Clinical trial design - including trial endpoints and statistical analyses
• Novel / alternative approaches to gathering data to support regulatory decision-making
• Clinical safety evaluation
• Labelling aspects and post-marketing monitoring of vaccine safety and effectiveness
• Issues related to manufacturing process and controls, as relevant

This cluster aims to discuss the evidentiary basis, regulatory context, and scientific rationale for each participating agency’s approach to vaccine development and licensure. This is intended to achieve convergent views where possible.

The EMA's Emergency Task Force (ETF) and the Vaccines Working Party support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Terms of reference for the European Medicines Agency, Health Canada and United States Food and Drugs Administration cluster on vaccines

For more information, see:

• Emergency Task Force (ETF)
• Vaccines Working Party 

Veterinary medicinal products

The table below provides at-a-glance information on when the veterinary medicinal products cluster was established, its meeting frequency and participation:

Established	2005
Meeting frequency	Every quarter
Participants	EMA, US FDA

This cluster aims to:

• Facilitate the exchange of information related to veterinary medicinal products and novel therapies under evaluation
• Achieve greater international cooperation

It supports a range of activities, including:

• Offering a confidential space for exchanging draft documents, policies in development, and detailed scientific information supporting regulatory decision‑making
• Serving as a collaborative platform for broader veterinary‑medicines topics
• Promoting the use of parallel scientific advice
• Strengthening international cooperation on antimicrobial resistance (AMR) and International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) activities;
• Coordinating work with the veterinary pharmacovigilance cluster and fostering collaboration on good manufacturing practice inspections for veterinary medicines

The EMA's Committee for Veterinary Medicinal Products (CVMP) and related working parties support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Veterinary medicinal products cluster - Terms of reference

For more information, see:

• Committee for Veterinary Medicinal Products (CVMP)

Veterinary pharmacovigilance

The table below provides at-a-glance information on when the veterinary pharmacovigilance cluster was established, its meeting frequency and participation:

Established	2017
Meeting frequency	Every quarter
Participants	EMA, US FDA, Health Canada

This cluster aims to promote the exchange of information on key pharmacovigilance issues and surveillance methodologies. This supports the development of related expertise.

Its confidential discussions may strengthen surveillance procedures and enable earlier identification of issues. They may also support actions coordinated informally, when needed.

It aims to achieve a shared understanding of each participating agency’s approach to pharmacovigilance surveillance and the communication of safety issues. It also aims to provide a forum to discuss systems for collecting and analysing adverse events.

In addition, it offers a confidential space for exchanging information related to the benefit–risk profile and safety concerns of specific veterinary medicinal products. This helps promote aligned and science‑based regulatory decision‑making.

The EMA's Committee for Veterinary Medicinal Products (CVMP) and related working parties support the work of this cluster.

More information on the work of this cluster is available in the terms of reference below:

Veterinary pharmacovigilance cluster - Terms of reference

For more information, see:

• Committee for Veterinary Medicinal Products (CVMP) 

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in July 2026.

See update history

17 July 2026

Full page revised to update the activities of previous published clusters and to include 15 new clusters.