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Collaboration between FDA and EMA. Belgian Economic Mission to the USA Washington DC - June 28, 2011. Presented by: Hilde Boone European Medicines Agency Liaison Official at the U.S. FDA. 1. Framework for collaboration. The European Medicines Agency (EMA).

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Collaboration between fda and ema

Collaboration between FDA and EMA

Belgian Economic Mission to the USA

Washington DC - June 28, 2011

Presented by: Hilde Boone

European Medicines Agency Liaison Official at the U.S. FDA

1. Framework for collaboration

FDA-EMA collaboration - HB June 2011

The european medicines agency ema
The European Medicines Agency (EMA)

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

FDA-EMA collaboration - HB June 2011

EMA and the EU Regulatory System

  • EMA was created in 1995

  • Platform for public health issues at EU levelPooling of best scientific expertise from EU

  • EU approval routes for new medicines:- Mutual Recognition & Decentralised Procedure ->national MSs- CentralisedProcedure ->EMA

  • 1 application, 1 evaluation, 1EU-wide authorisation

  • European medicines system composed of national authorities and EMA together

  • EMA: 6 Scientific Committees 4500+ EU scientific experts 560+ staff based in London, UK

  • Facilitate availability of new medicines to patients

  • Protect and promote public and animal health


FDA-EMA collaboration - HB June 2011

EMA-FDA Confidentiality Arrangements

Framework for regulatory cooperation between Agencies

Commitments to protect non-public information provided in confidence

Signed September 2003Extended indefinitely 2010

Scope: Human & Vet products under review by EMA and national prod. referred to CHMP

Exchange of (draft) guidance/guidelines

Staff/expert exchanges

Sharing of non-public, pre-decisional information



FDA-EMA collaboration - HB June 2011

2. Key areas of collaboration


FDA-EMA collaboration - HB June 2011

  • Product Development


  • Monthly teleconferences EMA-FDAincl. Health Canada, PMDA (Japan)

  • Share information on EMA Paediatric Investigation Plans (PIPs), FDA Written Requests and on Waivers

  • Share information on safety issues in children

  • Discuss new guidelines, scientific approaches

  • Aim at global development plans in children, compatible for both agencies

  • Avoid exposing children to unnecessary trials

  • Reduce administrative and regulatory burden

FDA-EMA collaboration - HB June 2011



  • Key topics in US Critical Path Initiative and EU Innovative Medicines Initiative (IMI)

  • Joint FDA/EMA Voluntary Genomic Data Submission briefing meetings

  • New EMA Qualification process for novel methodologies in drug development; applicants encouraged to apply to FDA and EMA

  • Joint FDA/EMA qualification of several new biomarkers

  • Share information and expertise in new areas

  • Aim at scientific consensus, common requirements

  • Facilitate global development

  • Safer medicines - earlier available - for right patient

FDA-EMA collaboration - HB June 2011



  • Voluntary procedure, at request of sponsor

  • Available to sponsors of a future IND, NDA, BLA & MAA(and supplements / variations)

  • Questions on product development put to both FDA and EMA

  • Discussions between FDA-EMA, and joint with sponsor

  • Each Agency will issue separate responses to sponsor‘s questions in line with usual procedures

  • Increased dialogue between Agencies and sponsor from early stages of development

  • Optimise and facilitate global development, meeting both agencies requirements

  • Sponsor can drive alignment between Agencies

FDA-EMA collaboration - HB June 2011

  • Product Evaluation and Surveillance

  • Share information on ongoing EMEA marketing authorisation applications (MAAs) and FDA applications (NDA / BLAs)

  • ‚Clusters‘ with regular FDA-EMA tele- or videoconferences e.g. oncology, vaccines, advanced therapies, pharmacovigilanceBiosimilars – kick-off in July 2011

  • EMA, CHMP Rapporteurs/assessors and FDA review division experts

  • Ad-hoc exchanges on specific review and safety issues

  • Observers at CHMP meetings / Advisory Committee meetings

  • Awareness of ongoing evaluationsopportunity for discussion / exchange of views

  • Understanding in case of different outcomes

  • Advance notice of important regulatory action

FDA-EMA collaboration - HB June 2011


Sept 2009 – Sept 2010

> 200 ad-hoc product exchanges± 100 teleconferences EMA-FDA 50% product-specific

FDA observed 4 CHMP and 4 SAG meetingsEMA/CHMP observed 8 Advisory Committee meetings

FDA-EMA collaboration - HB June 2011


Product Manufacturing & Compliance


Joint FDA-EMA inspections of finished product manufacturing sites in US & EU

2 joint pre-approval inspections in 2009

3 joint routine inspections in 1H2011

Pilot project to collaborate on inspections of API in third countries Participants: EU + US + Canada + Australia

Share info on planned and performed API inspections

Explore possibility to share outcome of site inspection or to perform a collaborative inspection

9 joint API inspections performed > 1000 site entries ± 100 inspection reports exchanged

FDA-EMA collaboration - HB June 2011



  • Pilot project - share info on inspections planned and performed Set-up joint or observational inspection; choose other site

  • 7 Joint GCP inspections 6 Observational GCP inspections

  • >50 products GCP info exchanged

  • Reports on API Pilot and GCP Pilot to be published shortly on EMA and FDA websites.

 Save resources, decrease duplicate inspections

 Increase number of API/CT sites inspected

 Contribute to risk-based inspection planning approach

FDA-EMA collaboration - HB June 2011


Report on “Interactions between the EMA and FDA; Sept 2009-Sept 2010”


FDA-EMA collaboration - HB June 2011

3. Benefits of collaboration


FDA-EMA collaboration - HB June 2011

Many transatlantic EU-US projects underwayIncreased communication between agencies and sponsors

Acknowledge importance of giving advance noticeof upcoming important regulatory decisions

Timely applicant/sponsor communication and information sharing with EMA and FDA is essential

FDA-EMA interactions will foster a culture of convergence

Contribute to increased consistency and predictability in regulatory approaches, as appropriate

Supporting a global approach to development, authorisation and supervision of medicines Availability of safe and effective new medicines, as early as possible, with data relevant to all regions.


FDA-EMA collaboration - HB June 2011

Thank you

Hilde Boone

European Medicines AgencyLiaison Official at FDA

White Oak, Silver Spring

+ 301 796 8357

[email protected]

[email protected]

FDA-EMA collaboration - HB June 2011

  • Active Pharmaceutical Ingredient

  • Committee for Human Medicinal Products

  • European Medicines Agency

  • Food and Drug Administration

  • Good Clinical Practice

  • Good Manufacturing Practice

  • Innovative Medicines Initiative

  • Marketing Authorisation (Application)

  • Member State

  • Paediatric Investigation Plan

  • Pharmaceuticals and Medical Devices Agency (Japan)

  • Scientific Advisory Group

  • API

  • CHMP

  • EMA

  • FDA

  • GCP

  • GMP

  • IMI

  • MA(A)

  • MS

  • PIP

  • PMDA

  • SAG


FDA-EMA collaboration - HB June 2011