An agency of the European Union

Presented by: Hilde BooneEuropean Medicines Agency Liaison Official at the U.S. FDA

Collaboration between FDA and EMA

Belgian Economic Mission to the USAWashington DC - June 28, 2011

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1. Framework for collaboration1. Framework for collaboration

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The European Medicines Agency The European Medicines Agency (EMA) (EMA)

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

www.ema.europa.eu

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• 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- Centralised Procedure ->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 patientsProtect and promote public and animal health

EMA and the EU Regulatory System

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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

EMA-FDA Confidentiality Arrangements

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2. Key areas of collaboration2. Key areas of collaboration

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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

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•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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•PARALLEL FDA-EMA SCIENTIFIC ADVICEVoluntary 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

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Product Evaluation and SurveillanceShare 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 evaluationsopportunity for discussion / exchange of views

Understanding in case of different outcomes Advance notice of important regulatory action

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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

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Product Manufacturing & Compliance

• GMP INSPECTIONS

Joint FDA-EMA inspections of finished product manufacturing sites in US & EU

2 joint pre-approval inspections in 20093 joint routine inspections in 1H2011

Pilot project to collaborate on inspections of API in third countriesParticipants: 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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• GCP INSPECTIONS

Pilot project - share info on inspections planned and performedSet-up joint or observational inspection; choose other site

7 Joint GCP inspections6 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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Report on “Interactions between the EMA and FDA; Sept 2009-Sept 2010”

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3. Benefits of collaboration3. Benefits of collaboration

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• Many transatlantic EU-US projects underwayIncreased 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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Hilde Boone European Medicines Agency

Liaison Official at FDA

White Oak, Silver Spring

+ 301 796 8357hilde.boone@fda.hhs.gov

hilde.boone@ema.europa.eu

Thank you

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AbbreviationsAbbreviations

• API

• 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