Cluster activities

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The European Medicines Agency (EMA) holds regular meetings by phone or videoconference 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.

The type of information exchanged includes applications for marketing authorisation and extensions of indications, including risk-management plans and evaluation of safety signals.

The clusters were initially set up by EMA and United States (US) Food and Drug Administration (FDA). Other global regulators, including Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Australian Therapeutic Goods Administration (TGA), now participate in some of the clusters.

In addition to regular cluster acticities, ad-hoc product- or issue-related teleconferences are also held when required.

 

Advanced-therapy medicinal products

  • Established: 2008
  • Meeting frequency: five to six times a year by teleconference, which are organised to coincide with the Committee for Advanced Therapies meetings.
  • Participants: EMA, FDA, Health Canada

The objective of the cluster is to develop a common understanding of each Agency’s regulatory approaches for advanced-therapy medicinal products (ATMPs). 

Documents exchanged include scientific advice, ATMP classification reports and assessment reports of marketing-authorisation applications from EMA and Investigational New Drug (IND), pre-IND, and pre-biologics-license-application meeting minutes from the FDA. Both agencies share their (draft) guidelines. 

 

Biosimilars

  • Established: 2011
  • Meeting frequency: three times a year by teleconference
  • Participants: EMA, FDA, Health Canada, PMDA

The objective of the cluster is the alignment on scientific approaches to the evaluation of biosimilar medicines in order to increase convergence, so that data developed for one regulatory authority could be acceptable to another regulatory authority. Information on biosimilar guidelines in development is exchanged in order to avoid major divergence in requirements and interactions and discussion on product-specific matters is facilitated.

 

Blood products

  • Established: 2010
  • Meeting frequency: quarterly by teleconference
  • Participants: EMA, FDA, Health Canada

The objective of the cluster is to discuss issues that affect the safety and efficacy of products that the Agencies regulate in common, and similarities or differences in resolving these issues. These discussions help understanding of the rationale behind respective regulatory approaches and facilitate similar conclusions and regulatory actions.

The types of documents exchanged and topics discussed are assessment reports, review memos, good-manufacturing-practice and good-clinical-practice inspections information as well as details of relevant workshops, advisory committee and other meetings.

 

Non-clinical oncology

  • Established: 2014
  • Meeting frequency: quarterly by teleconference
  • Participants: EMA, FDA

 

Oncology-haematology medicinal products

  • Established: 2004
  • Meeting frequency: monthly by teleconference
  • Participants: EMA, FDA, Health Canada, PMDA, TGA

The objective of the cluster is to share clinical review information, with a strong focus on clinical and statistical issues, of medicines to treat cancer under review by both agencies. Marketing-authorisation applications under review and at pre-submission are discussed.

The objective of this cluster is to support the oncology-haematology medicinal products cluster with focus on requirements for non-clinical studies identification of non-clinical safety issues for products under clinical trials.

 

Orphan medicinal products

  • Established: 2008
  • Meeting frequency: monthly by teleconference
  • Participants: EMA, FDA

The objective of the cluster is to collaborate on orphan designation, product development and administrative simplification. Routine cluster meetings focus on common orphan designation applications submitted, challenging scientific or regulatory aspects of applications, divergent opinions, draft guidance in development, revision of legislation and opportunities to collaborate at conferences and workshops with sponsors developing medicinal products for rare diseases.

The cluster has developed common procedures for applying for orphan designation and for submitting annual reports on the status of development of designated orphan medicines:

For more information on the application procedure and how to submit the annual report, see:

This cluster is complemented by the cluster on rare diseases which focuses on development and scientific evaluation of medicines for rare diseases.

 

Paediatric medicinal products

  • Established: 2007
  • Meeting frequency: ten to twelve times a year by teleconference
  • Participants: EMA, FDA, Health Canada, PMDA, TGA

The objective of the cluster is to help to support global development plans for paediatric medicinal products and to exchange information on applications and topics related to development.

EMA paediatric investigational plans (PIPs) as well as general topics related to paediatric drug development (methodology; study design; endpoints, safety issues, etc.) are discussed in detail and documents, such as Paediatric Committee summary reports, written requests, waivers and deferrals and from the FDA side new drug approval letters, Pediatric Review Committee discussions, Pediatric Research Equity Act requirements and outcomes of workshops and working groups are shared.

The agencies may prepare 'common commentaries' on selected applications. The common commentary is a tool to inform sponsors of products discussed at the paediatric cluster. The document provides informal, non-binding comments to sponsors on paediatric development plans that have been submitted to both FDA and EMA, which are under review by both agencies and have been discussed at the cluster.

The agencies established working groups on formulation, non-clinical and on Inflammatory Bowel disease for paediatric ulcerative colitis. They published a number of joint articles and editorials.

More information: 

EMA/FDA strategy for innovative medicine development for rare paediatric diseases (updated)

EMA and FDA have developed a joint strategy to encourage the use of innovative approaches in medicine development for Gaucher disease, which can apply to rare diseases in children in general. The approach aims to reduce the number of patients needed for clinical trials.

It recommends making better use of extrapolation of available clinical data and encourages the testing of the safety and efficacy of medicines developed by different companies in one single trial, so-called multi-arm, multi-company clinical trials.

EMA and FDA advise medicine developers who wish to apply these approaches to seek scientific advice. They can approach EMA or FDA separately, or request parallel scientific advice.

For more information, see:

Patient engagement

  • Established: 2016
  • Meeting frequency: quarterly by teleconference
  • Participants: EMA, FDA

The objective of the cluster is to share best practices on involving patients along the medicine’s regulatory lifecycle, to further improve and extend both agencies' current actives in this area.

More information:

 

Pharmacogenomics

  • Established: 2005
  • Meeting frequency: bi-annualy by teleconference
  • Participants: EMA, FDA, PMDA

The objective of the cluster is the development and the harmonisation of international guidelines on issues related to pharmacogenomics. Exchanges of information on pharmacogenomics-related products issues under parallel assessment and on pharmacogenomics policy-related issues are discussed and related documents are exchanged.

EMA and the FDA accept joint applications for qualifications of bimarkers/ clinical outcome assessments (COAs).

More information:

 

Pharmacometrics / Modelling and simulation

  • Established: 2016
  • Meeting frequency: quarterly by teleconference
  • Participants: EMA, FDA, PMDA, Health Canada

The objective of the cluster is to exchange information and perspectives on pharmacometrics, including guidelines, workshops, publications and products under parallel assessment. The Agencies will also work towards the harmonisation of their practices and activities in this area.

 

Pharmacovigilance

  • Established: formally in 2013, although regular teleconferences between the FDA and the Committee for Medicinal Products for Human Use Pharmacovigilance working party took place between 2003 and 2013.
  • Meeting frequency: monthly by teleconference
  • Participants: EMA, FDA

The objective of the cluster is the sharing of information on drug safety issues and to provide advance notice of anticipated regulatory action, public information and communication prior to decision-making and publication. Product-related risk assessments with a special focus on emerging safety concerns, policies, guidance documents and regulations are typically exchanged during the cluster meetings.

More information: 

 

Rare diseases

  • Established: 2016
  • Meeting frequency: three to four times a year by teleconference
  • Participants: EMA, FDA

The objective of the cluster is to exchange information on the development and scientific evaluation of medicines for rare diseases, including on conducting clinical trials in small populations, obtaining preclinical evidence to support development programmes, risk management strategies for long-term safety issues and the design of post-marketing studies, in particular in the context of early access mechanisms such as EMA’s conditional marketing authorisation and FDA’s accelerated approval.

This cluster complements the cluster on orphan medicinal products, which focuses on orphan designation, a regulatory mechanism for encouraging the development of medicines for rare diseases. 

More information:

 

Vaccines

  • Established: 2005
  • Meeting frequency: quarterly by teleconference
  • Participants: EMA, FDA, Health Canada

The objective of the cluster is to discuss issues that affect the safety and efficacy of products that EMA and FDA regulate in common, and the similarities or differences that might exist in resolving these issues. Assessments reports, review memos, package inserts, study protocols, guidance documents and advisory are shared during the meetings.

 

Veterinary medicinal products

  • Established: 2005
  • Meeting frequency: quarterly by videoconference
  • Participants: EMA, FDA

Agenda topics include current and future applications for marketing authorisation, for scientific advice and for maximum residue limits, guidelines review, Veterinary International Conference on Harmonization (VICH) issues, safety and pharmacovigilance issues, drug shortages, quality defects and use of novel technologies. 

Exchanges regarding approaches for requirements and assessment of novel therapy products have been proven highly valuable in developing guidance and moving towards consistency in requirements.

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