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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. The European Medicines Agency (EMA).

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Collaboration between FDA and EMA

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  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

  2. 1. Framework for collaboration FDA-EMA collaboration - HB June 2011

  3. 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

  4. 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 4 FDA-EMA collaboration - HB June 2011

  5. 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 5 5 FDA-EMA collaboration - HB June 2011

  6. 2. Key areas of collaboration 6 FDA-EMA collaboration - HB June 2011

  7. 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 7

  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 FDA-EMA collaboration - HB June 2011 8

  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, 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 10

  11. 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 11

  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 FDA-EMA collaboration - HB June 2011 12

  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 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 13

  14. Report on “Interactions between the EMA and FDA; Sept 2009-Sept 2010” 14 FDA-EMA collaboration - HB June 2011

  15. 3. Benefits of collaboration 15 FDA-EMA collaboration - HB June 2011

  16. 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. 16 FDA-EMA collaboration - HB June 2011

  17. 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

  18. 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

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