Post on 22-Dec-2015
An agency of the European Union
Presented by: Hilde BooneEuropean Medicines Agency Liaison Official at the U.S. FDA
Collaboration between FDA and EMA
Belgian Economic Mission to the USAWashington DC - June 28, 2011
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1. Framework for collaboration1. Framework for collaboration
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The European Medicines Agency The European Medicines Agency (EMA) (EMA)
7, Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom
www.ema.europa.eu
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• 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- Centralised Procedure ->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 patientsProtect and promote public and animal health
EMA and the EU Regulatory System
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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
EMA-FDA Confidentiality Arrangements
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2. Key areas of collaboration2. Key areas of collaboration
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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
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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
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•PARALLEL FDA-EMA SCIENTIFIC ADVICEVoluntary 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
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Product Evaluation and SurveillanceShare 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, pharmacovigilance Biosimilars – 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
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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
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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 20093 joint routine inspections in 1H2011
Pilot project to collaborate on inspections of API in third countriesParticipants: 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
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• GCP INSPECTIONS
Pilot project - share info on inspections planned and performedSet-up joint or observational inspection; choose other site
7 Joint GCP inspections6 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
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Report on “Interactions between the EMA and FDA; Sept 2009-Sept 2010”
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3. Benefits of collaboration3. Benefits of collaboration
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• Many transatlantic EU-US projects underwayIncreased communication between agencies and sponsors
• Acknowledge importance of giving advance notice of 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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Hilde Boone European Medicines Agency
Liaison Official at FDA
White Oak, Silver Spring
+ 301 796 8357hilde.boone@fda.hhs.gov
hilde.boone@ema.europa.eu
Thank you
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AbbreviationsAbbreviations
• API
• CHMP
• EMA
• FDA
• GCP
• GMP
• IMI
• MA(A)
• MS
• PIP
• PMDA
• SAG
• 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