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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

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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

www.ema.europa.eu

FDA-EMA collaboration - HB June 2011

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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

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FDA-EMA collaboration - HB June 2011

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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

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FDA-EMA collaboration - HB June 2011

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2. Key areas of collaboration

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FDA-EMA collaboration - HB June 2011

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Product Development
  • PAEDIATRIC MEDICINE
  • 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

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BIOMARKERS and PHARMACOGENOMICS
  • 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

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PARALLEL FDA-EMA SCIENTIFIC ADVICE
  • 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

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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

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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

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Product Manufacturing & Compliance

GMP INSPECTIONS

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

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GCP INSPECTIONS

  • 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

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

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FDA-EMA collaboration - HB June 2011

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3. Benefits of collaboration

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FDA-EMA collaboration - HB June 2011

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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.

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FDA-EMA collaboration - HB June 2011

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Thank you

Hilde Boone

European Medicines AgencyLiaison Official at FDA

White Oak, Silver Spring

+ 301 796 8357

hilde.boone@fda.hhs.gov

hilde.boone@ema.europa.eu

FDA-EMA collaboration - HB June 2011

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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

Abbreviations

FDA-EMA collaboration - HB June 2011