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Harmonization-Collaboration FDA and EMA Activities

Harmonization-Collaboration FDA and EMA Activities. Janice M. Soreth, M.D. FDA Liaison to EMA Deputy Director, FDA Europe Office. Contents. Framework for collaboration Mechanisms for interaction Examples of regular and some new interactions Activities and achievements The next steps. ICH

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Harmonization-Collaboration FDA and EMA Activities

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  1. Harmonization-CollaborationFDA and EMA Activities Janice M. Soreth, M.D. FDA Liaison to EMA Deputy Director, FDA Europe Office

  2. Contents • Framework for collaboration • Mechanisms for interaction • Examples of regular and some new interactions • Activities and achievements • The next steps

  3. ICH • EMA/EC - FDA Bilateral Meetings • EMA/EC - FDA Confidentiality Arrangements • Signed in 2003 • Implementation plan agreed in 2004 (H) + 2008 (V) • Extended for 5 years in 2005 • Extended indefinitely in 2010 • Transatlantic Administrative Simplification- Action plan agreed 2008

  4. 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 FDA and by EMA, and national prod. referred to CHMP Exchange of (draft) guidance/guidelines Staff/expert exchanges Sharing of non-public, pre-decisional info 4 4

  5. Mechanisms for information exchange - examples • Exchange of review documents and assessment reports • Regular tele-/videoconferences on specific topics and product classes • Ad-hoc teleconferences between US-EU experts • Sharing of pharmacovigilance and inspections information • Joint and collaborative GMP/GCP inspections • Participation at workshops, meetings, trainings • Agency Liaison placements • Ad-hoc Agency staff visits

  6. Cross-agency activity and commitmentInvolvement of FDA Review Office/Divisions and EMA Staff, Committee/WP members & Experts Coordination by EMA International Office and FDA Office of International Programs, in close collaboration with the CDER/CBER/CVM International Officers

  7. Examples of Regular (and some new) Interactions • Exchange listings of ongoing EMA marketing authorisation applications (MAAs) and FDA applications (NDA/BLAs) • “Cluster” areas with regular FDA-EMA tele- or videoconferencesto exchange information on ongoing applications: oncology, orphan drugs, paediatrics, vaccines, blood products, pharmacogenomics, advanced therapies, veterinary drugs • Cluster on Biosimilars – kick-off in July 2011 • EMA participants: Rapporteurs and Assessors, Committee or working party members Section head, PTL • FDA participants: Office/Division Directors, reviewers and experts

  8. Examples of Regular (and some new) Interactions – continued • Quality by Design pilot – two products (one chemical, one biological by anology) under review, PMDA involved as observer • Increased uptake of Parallel Scientific advice and Biomarker Qualifications • New interactions have developed in cardio renal, diabetes, neurology, and rheumatoid/pulmonary areas

  9. ‘Cluster’ Agenda: - Products under evaluation; post-approval changes- Scientific Advice / INDs / SPA- Safety issues; upcoming communications- Draft guidelines, guidances- General policy issues- Upcoming meetings of interest; joint workshops- Feedback from CHMP / Advisory Com / SAG meetings • Teleconference/Videoconference1 - 1.5h meetings • Health Canada and Japan participation in some clusters • Increase of product discussions starting in first phase of assessment • Awareness, understanding of upcoming product decisions

  10. Typical content and format of cluster meetings • Extensive ad-hoc exchanges and teleconferences on product specific review and safety issues • Request from EMA/CHMP or FDA Reviewer • Triggers: Questions during ongoing reviewFDA or EMA announcementsSponsor information • Exchange of assessment reports and review documentsSet-up teleconferenceObserve CHMP / SAG meetingsObserve Advisory Committee meetings (webcasts)Feedback to CHMPMay require further clarification from company; consider for LoQ

  11. Regular, bi-monthly videoconferences on pharmacovigilance • EMA + PhVig WP chair and members + Rapporteurs/expertsOrganised by FDA CDER Office of Surveillance and Epidemiology + relevant CDER & CBER division • Issues • New safety signals; exchange of findingsInterpretation of data • Feedback from CHMP / PhVig WP / Advisory Committee Upcoming label / SmPC changes • Discussion of RMP / REMs

  12. FDA and EMA give advance notice of upcoming important regulatory decisions and SmPC/label changes • Tools:‘Cluster’ discussionsEMA sends pre-CHMP ”Early Notification System” to FDAEMA shares draft CHMP Press Release with FDAFDA sends advance copy of AERS / safety monitoring postings, advance notice of Drug Safety CommunicationsAd-hoc sending of upcoming press statements, Q&A, SmPC/Label • FDA/EMA to check available data and current SmPC/Label • - request further background information; set-up teleconference, consider regulatory action • FDA/EMA may prepare public communications, EMA informs EU regulatory network

  13. Parallel Scientific Advice • First Parallel Scientific Advice (PSA) issued October 2003 • Available to sponsors of a future IND, NDA/BLA, MAA • Voluntary procedure, at request of sponsor • Informally explore EMA-FDA interest à formal PSA request • FDA and EMA contact points to be set-up to organise PSA procedure and interactions • Questions on product development + same briefing packagesubmit to both FDA and EMA • Procedural steps and discussions are scheduled around the SAWP meeting dates. • Fit with 60-days Type B meetings and 70-days SA procedure

  14. Parallel Scientific Advice (cont.) • Exchange of reports/responses between FDA-EMA • Teleconferences during SAWP meetings between FDA-EMA • FDA-EMA agree on List of Questions to be sent to sponsor • Joint ‘discussion meeting’ teleconference with sponsor (Day 60)EMA or FDA will chair the meetingSponsor present at meeting in London and/or at FDA • Possibility of separate meetings with observerships • Each Agency will issue separate responses to sponsor‘s questions in line with usual procedures

  15. Parallel Scientific Advice (cont.) • Limitations and Benefits of FDA-EMA Parallel Scientific Advice: • Timelines linked to SAWP meetings; need for careful planning and coordination; contact EMA & FDA well in advance • Industry fear of higher thresholds; separate not joint answers • Awareness that PSA meetings can replace or be complementary to key milestone FDA meetings • Especially useful at early stages in developmentIn areas with no/limited guidance,easier to align • Great opportunity for sponsors to coordinate EU and US activities • Sponsor can drive (partial) alignment between Agencies

  16. GMP and GCP Collaborations • Began in 2009 as 18-24 month pilots • GMP cooperation on APIs and Finished Products • GCP cooperation on Clinical Trial inspections • GXP programs continue as monthly/every other month exchanges of inspection planning info, exchange of inspection observations, reports • Participation in each others training programs • Observed and joint inspections • ‘Confidence built’ promotes ‘reliance upon’

  17. Next Steps

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