Bilateral arrangements Bilateral arrangements Challenges and - PDF document

Bilateral arrangements Bilateral arrangements Challenges and opportunities for Challenges and opportunities for Croatia Croatia • Currently 3 arrangements 13-14 November 2008 – EU/US FDA – EU/Japan MHLW-PMDA Transatlantic simplification of Transatlantic simplification of administrative procedures administrative procedures – EU/Health Canada • EU represented by European Commission Arielle North and EMEA EMEA EU/US FDA arrangement EU/US FDA arrangement • Scope central applications/authorisations and • Signed in September 2003 for 2 years referrals • Implementation plan and pilot programme • Specific topics for parallel scientific advice signed in – Guiding principles for joint FDA/EMEA voluntary genomic data submission briefing meetings in May September 2004 2006 • Extension of the arrangement for 5 years – Principles of interaction between EMEA and FDA on signed in September 2005 paediatric therapeutic in June 2007 – The EU and FDA have created a common application • Implementation plan updated in June 2007 form for orphan designation in November 2007 – Clusters • Some outcomes • Already: oncology, vaccines, orphans, paediatrics, – Quarterly reports on on-going procedures pharmacogenomics – Safety information • On going: advanced therapies, central nervous • Systematic safety warnings before each CHMP meeting system, diabetes • Case-by-case – Common orphan designation forms – Inspections • Case-by-case – Exchange of staff • Database access – General information – EMEA access to COMSTAT – EudraGMP access for FDA on going – Face to face meetings once a year – Includes module for sharing inspections plans 1

EU/Health Canada arrangement EU/Japan MHLW- EU/Japan MHLW -PMDA arrangement PMDA arrangement EU/Health Canada arrangement • Signed in February 2007 • Signed in December 2007 • Implementation plan still under preparation • Implementation plan still on going • Exchanges already in place • Will be probably very similar to the FDA • Mainly focused on product specific issues • Exchanges already in place • Language represents a challenge Transatlantic Administrative Transatlantic Administrative Simplification Simplification • Built on successful bilateral cooperation • Milestones EU/FDA – First trimester 2007 project agreed EU/US • Political support of the Transatlantic – Second-third trimester 2007 consultation EU/US pharmaceutical industry Economic Council (TEC) – 28 November 2007 workshop examination of • Workshop November 2007 proposals • List of possible deliverables – June 2008 publication of the Action Plan by • Action Plan to be prepared the EU and FDA Workshop November 2007 Workshop November 2007 • Objectives • Under the auspices of the TEC – Harmonisation • Hosted by the Commission – Reduction administrative burden • Organised in collaboration with EMEA and – Saving resources Heads of Agencies • Rules • Co-chaired by Commission/FDA – No change in the EU/US legislation • EU Industry organisations (EFPIA, EGA, – Transatlantic dimension AESGP, EuropaBio) – Not reduce public health • US Industry organisations (BIO, CHPA, PhRMA) • For administrative practices/guidelines 2

• Methodology • Large range of proposals – Identification opportunities for administrative • Organised in four thematic panels simplification – Proposals for possible deliverables – Quality and inspections • Bilateral work (confidentiality arrangements) – Pharmacovigilance • Multilateral work (e.g. ICH) – Scientific collaboration • Careful selection on unnecessary burden on administrative practices – Guidelines, formats, electronic submission • Legal/practical considerations • List of agreed actions – Publication of an action Plan Action Plan Action Plan Transatlantic Economic Council Transatlantic Economic Council • Original long list shortened • Meeting 13 May 2008 • ICH topics to be pursued under ICH umbrella (4 • TEC noted for pharmaceuticals projects mainly related to CTD) – Commission/EMEA and FDA • 14 projects • Pilot joint inspections in the EU and US and inspections of active substance manufacturers in third countries – Specified deliverables • Pilot exchange inspection schedules and results active – Realistic deadlines substances in third countries – EU/FDA lead persons • Dedicated production facilities for certain medicines on risk- based approach, revision EU guideline • Published 18 June 2008 Biomarkers Biomarkers – EMEA and FDA • Industry has been cautious on sharing • Biomarkers development and validation information with regulators on genomics • Cooperation in the field of veterinary medicinal products • Workshops at the EMEA • Introduction of the concept “safe harbour” to facilitate exchanges • Done through Pharmacogenomics Working Party • Involving also experts from Academia 3

• Industry collecting important amount data • First common EMEA-FDA acceptance to qualify • Pooled data from different companies the use of 7 biomarkers • Critical mass of scientific information • Pilot experience • Submission to both agencies • EMEA/FDA conclusion • Strong collaboration with FDA – Renal biomarkers submitted are acceptable in the • Joint evaluation context of non-clinical development for detection acute drug-induced renal toxicity • At ICH level – Added value to currently available standards – Terminology – Use of renal biomarkers in clinical trials case-by-case – Format submission data basis to gather further data Quality and Inspection Quality and Inspection • Final report public consultation until June 2008 • EU-US Bilateral Technical Working Group • Introducing new routine scientific advice, on Human and Veterinary (Medicines methodology and qualification procedure April Quality and Manufacturing) 2008 – Meeting EU/FDA October 2007 • Publication on EMEA website of a Guidance to – Terms of reference adopted Applicants for procedure on Biomarkers Qualification for consultation until 30 June 2008 – Quarterly meetings (video/teleconferences) • Comments will be taken into account • Collaboration on guidelines on dedicated • Specific targets agreed facilities (for products with high risk of cross contamination) – Pilot joint inspections in US and EU for finished products – Revision of the EU GMP guidance – Pilot joint inspections outside EU/US for active – FDA guidance for penicillins/cephalosporins substances (APIs) – Risk based approach – Pilot exchange of inspection schedules and results • EMEA access to COMSTAT • Risk based approach/high risk products • EudraGMP • Sites of interest – Access for FDA on going • No duplication and more effective use of resources – Includes module for sharing inspection plans • Higher safety level for products coming from third countries 4

Other Projects Other Projects Pilot programme for APIs Pilot programme for APIs • Already on going (parallel scientific advice, • Within this framework but including more paediatrics) participants (Canada, Australia) • To be further developed (risk management • Agreement to share inspection plans plans, biologicals/biosimilars, counterfeits, • Coordination/collaboration on sites of inetrest advanced therapies) • Possible joint inspections • To start (herbal medicinal products) • Greater transparency from manufacturers • Risk based approach Conclusion Conclusion • The transatlantic administrative simplification project has been built on – Confidence – Experience due to daily exchanges – Commitment from both parties • Follow up within the bilateral face to face meetings • Results to be regularly published within the TEC umbrella 5