EMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP)

Transcription

1 EMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP) European Health Forum - 3 rd October 2013 Falk Ehmann MD, PhD European Medicines Agency - London

2 Contents Basis for Transatlantic dialogue between authorities Status of current Bilateral arrangements Examples of on-going collaboration with FDA Transatlantic Trade and Investment Partnership Next steps and conclusions 2

3 Basis for Transatlantic dialogue between authorities Long history of ad hoc collaboration with FDA (EC and individual member states) before there was an EMA 3 History of going from personal, ad hoc interactions to interactions being formalized and an integral part of how EMA and FDA work together on a daily basis

4 Current Regulatory Framework Confidentiality arrangement 2003 à extended indefinitely in 2010 Implementation Plan Annual Bilaterals EC/EMA/US FDA 4

5 EMA-FDA Confidentiality Arrangements Framework for regulatory cooperation between Agencies Commitments to protect non-public information provided in confidence Signed September 2003 Extended indefinitely 2010 Scope: Human & Vet products under review by EMA and national prod. referred to CHMP 5 Exchange of (draft) guidance/guidelines Staff/expert exchanges Sharing of non-public, predecisional information

6 Mechanisms for information exchange - examples Exchange of assessment reports and review documents Regular tele- / videoconferences on specific topics and product classes Ad-hoc teleconferences between EU-US experts Sharing of pharmacovigilance and inspections information Joint and collaborative GMP/GCP inspections Participation at workshops, meetings, trainings Agency Liaison placements: Janice Soreth (FDA) at EMA since June 2009 Hilde Boone (EMA) at FDA since Jan 2010 to March 2012 Sabine Haubenreisser (EMA) at FDA since July

7 Cross-agency activity and commitment Involvement of Committee/WP members & experts Sending of documents through Eudralink (secure portal) Coordination by EMA International Office and FDA Office of International Programs, in close collaboration with the CDER/CBER/CVM International Officers 7

8 Status of Interactions Now around 80 formal interactions per month and numerous daily informal interactions including s/ phone calls at all leadership and programmatic levels within the two organisations Senior executive leadership International leadership Programmatic leadership Technical experts 8

9 Examples of Regular Interactions Exchange listings of ongoing EMA marketing authorisation applications (MAAs) and FDA applications (NDA/BLAs) Cluster areas with regular FDA-EMA tele- or videoconferences to exchange information on ongoing applications: oncology, orphan drugs, paediatrics, vaccines, blood products, pharmacogenomics, advanced therapies, veterinary drugs, Biosimilars EMA participants: Rapporteurs and Assessors, Committee or working party members, Section Heads, PTLs FDA participants: Office/Division head, reviewers and experts Bi-monthly Videoconferences on Pharmacovigilance (on hold) Regular exchanges on GMP (API and FP), GCP, Quality 9 9

10 Specific transatlantic/international activities Biosimilars New Cluster July 2011 Quality by Design pilot first product received, PMDA involved as observer International Generic initiative European model to be used internationally Active Substance Master File Initiative European model to be used internationally Extension of GCP initiative to bioequivalence studies API (Active Pharmaceutical Ingredient) inspection programme GMP inspection pilots moving from confidence building to reliance upon 10 10

11 GMP inspection initiatives API pilot launched 12/2008 à API inspection programme published 6/3/2012 Objective: To foster greater international collaboration and information sharing to help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication Now involves WHO and additional EU authorities as well as FDA and TGA FDA inputs data into EudraGMP Finished Product GMP pilot Joint inspections Principles published 11/2010 Mutual Reliance on inspections à GMP Inspection cooperation EMA/FDA published 12/2011 Allows some inspections on each others territories to be deferred or waived à moving from confidence building to reliance upon 11 11

12 GCP inspection initiatives Initial GCP inspection initiative focused on new chemical entities and FDA-EMA inspections Objectives: to conduct periodic information exchanges on GCP-related information, To conduct collaborative GCP inspections and to share information on interpretation of GCP Focused on information and work sharing, collaborative inspections (Joint, Observed) Extended GCP inspection initiative involves wider range of member states (UK, IT, DE, FR, NL (BE planned)) and will additionally streamline inspection resources for bioequivalence studies Collaboration extended to non-eu, non-us sites Major benefits to regulators and industry expected Possibility of Joint (system related) or observed inspections May also cover follow-up for cause triggered inspections 12 12

13 Transatlantic Trade and Investment Partnership (TTIP) Consultation launched in EU and US September 2012 Responses received from wide range of stakeholders including EFPIA/PhRMA and EGA/GPhA October 2012 Mutual Recognition of Inspection findings Global development of data requirements for Biosimilar Approvals A single development programme and harmonisation of data requirements for Generic Medicinal products Pharmacopoeial harmonisation Other inputs on paediatric medicines, parallel scientific advice, IP rights, advanced manufacturing Builds on activities already in place between authorities Needs a convergence of approaches to transparency/confidentiality of information 13

14 Conclusions Transatlantic (and wider international) regulatory dialogue well established as part of daily activities of agencies Increasing globalisation and complexity of operations make this essential Changing economic environment and enhanced focus on transparency contributing factors Resource constraints, increasing need for work and information sharing, international collaboration, synergies and avoidance of duplication Scrutiny from media and parliament, more information in public domain Important to focus efforts on areas of most benefit to patients 14 14

15 1 5 The proactive regulatory approach: Be part of it and shape it together.

16 Link to Initiatives EMA public website EMA-FDA GCP initiative EMA-FDA GMP initiative /10/WC pdf Programme to rationalise international GMP inspections of APIS : Terms of reference and procedures for participating authorities Enhancing GMP inspection cooperation between the EMA and FDA Interactions between the European Medicines Agency and U.S. Food and Drug Administration September 2009-September

17 Thank you for your attention 8 falk.ehmann@ema.europa.eu ( Acknowledgements: Emer Cooke (Head International Affairs)