1. 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

2. 1. Framework for collaboration
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3. The European Medicines Agency (EMA)
7, Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom
FDA-EMA collaboration - HB June 2011

4. EMA and the EU Regulatory System
EMA was created in 1995
Platform for public health issues at EU level Pooling 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: Scientific Committees EU scientific experts staff based in London, UK
Facilitate availability of new medicines to patients
Protect and promote public and animal health
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5. EMA-FDA Confidentiality Arrangements
Framework for regulatory cooperation between Agencies
Commitments to protect non-public information provided in confidence
Signed September Extended 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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6. 2. Key areas of collaboration
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7. Product Development PAEDIATRIC MEDICINE
Monthly teleconferences EMA-FDA incl. 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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8. 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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9. 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

10. 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, 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 evaluations opportunity for discussion / exchange of views
Understanding in case of different outcomes
Advance notice of important regulatory action
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11. Sept 2009 – Sept 2010
> 200 ad-hoc product exchanges ± 100 teleconferences EMA-FDA % product-specific
FDA observed 4 CHMP and 4 SAG meetings EMA/CHMP observed 8 Advisory Committee meetings
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12. 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
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13. GCP INSPECTIONS
Pilot project - share info on inspections planned and performed Set-up joint or observational inspection; choose other site
7 Joint GCP inspections 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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14. Report on “Interactions between the EMA and FDA; Sept 2009-Sept 2010”
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15. 3. Benefits of collaboration
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16. FDA-EMA interactions will foster a culture of convergence
Many transatlantic EU-US projects underway Increased 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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17. Thank you
Hilde Boone
European Medicines Agency Liaison Official at FDA
White Oak, Silver Spring
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18. Abbreviations API Active Pharmaceutical Ingredient 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
FDA-EMA collaboration - HB June 2011