EFPIA Proposals for IT Support to the European Regulatory Procedures

1. EFPIA IT Proposals EFPIA Proposals for IT Support to the European Regulatory Procedures Mr S. Hasler EFPIA PAT Regulation 2000

2. EFPIA IT ProposalsKey Benefits • More rapid processes • More efficient processes • Remove duplication • Increase transparency

3. EFPIA IT ProposalsGeneral Principles (1) • Intent to remove need for paper copy • Sufficient IT and business resource committed by agencies and industry • Collaborative industry/agency approach to agreed initiatives • Clear benefits for industry and agencies • Agreed priority order for progression of initiatives

4. EFPIA IT ProposalsGeneral Principles (2) • Single standards, in line with ICH, implemented across Europe • One system across all agencies, wherever possible • Integrated systems across all agencies, otherwise

5. EFPIA IT ProposalsThe Future for Europe • Dossiers and data submitted to a single EU repository • e-submissions implemented in support of full lifecycle • eCTD implemented • eADR submission implemented • management of static and dynamic data • Transparent process tracking systems • Secure email and document exchange systems

6. Networked ReviewMAA Submission Agencies Applicant Applicant R e p o s I t o r y S i n g l e E U Approval M2 M2 MAA Questions E-mail Link during Assessment Transparent progress during review Responds to Questions Receives Approval Prepare e-CTD Submit to EU Network Consolidate e-Review e-Review

7. EFPIA IT ProposalsThe Benefits • Single set of information for EU decision making • Supports EU expansion • Improves Pharmaco-vigilance system • Bring products more quickly to patients • Supports single review for Europe • Improved filing and archiving • Data integration across product life-cycle • Improved information sharing and exchange • Improved tracking and project management

8. EFPIA IT ProposalsShort Term Initiatives (Before 2002) • Secure electronic transmission • document exchange • e-mail • e-Submission of small dossiers • Management of Dynamic Data - PIM • e-Submission of ADRs • Transparent process tracking systems Support with Appropriate Guidelines and Directives

9. Secure Electronic Transmission between Industry and Agencies • Implement system supporting • Secure 2-way transmission of small volumes of information, e.g. • variations • responses • Secure 2-way e-mail • Platform underpinning all e-interactions • Eudrasafe? • One system for EU

10. Dynamic Data Life cycle Management Growing dossier Static Data One-off submission - Administrative Data - Product Information Module 2 Module 2 1 Quality Overall Summary Clinical Overview and Summary Non-Clinical Overview and Summary 3 5 5 Quality Data 4 Non-Clinical Efficacy Data ADR data Database Exchange, XML Approach Single EU Database Single EU Repository Static and Dynamic Data CTD 1 Regional Admin Info Non-Clinical Overview and Summary Clinical Overview and Summary Quality Overall Summary 3 Quality 4 Non-Clinical 5 Clinical Implement CTD

11. Implement e-submissions Stepwise approach using eCTD standards: • Small dossiers submitted as pdf, e.g. variations • Establish dynamic data exchange and management • continue to support PIM • Implement eCTD for new products

12. Establish Dynamic Data Exchange and Management • Dynamic data in the dossier to be exchanged • Using defined exchange standard • Database to database • Potential areas for collaborative initiatives • Management and submission of product information (PIM) • Management and submission of CMC (Module 3) • Cumulative table of contents • CMC data, starting with small element of data, e.g. specification • Administrative data (Module 1) • Provides EU input to evolving eCTD • PIM included in module 1 of eCTD

13. Overdose_s Overdose_p Duration Life Submit Updated Parts only Overdose_s Overdose_p Overdose_s Overdose_p Duration Duration Life Life XML V 1.0 XML V 1.1

14. Benefits from PIM • Removes duplication of work across a product • Creation of documents by applicant • Review of documents by agency • Brings resource efficiencies • Reduces number of translations • Faster notification of changes proposed by agencies or industry • Capability to support administrative aspects of Decision Making Process and reduce time • Capability to support MR and National processes

15. e-Submission of ADRs • Implement full production system • Engage more agencies • Engage more of industry • Ensure ICSR activity supported by secure electronic data exchange

16. Process tracking system • Implement process tracking system in EU • Key benefits • Transparent European information • Instant access for industry and regulators to key information about specific regulatory tasks • Automated process measurement and prompting / alerting of key dates and milestones • Instant access to the tracking system and information about own applications • Availability both for the centralised and the mutual recognition procedures • Different tracking systems implemented at present at a national level (e.g. MCA's RAMA) made compatible

17. EFPIA IT ProposalsLonger Term Initiatives (Before 2004) • Implement eCTD • Single EU Submission Repository • Management of Dynamic Data - other dossier components • CMC • Administrative data • Single EU ADR database Support with Appropriate Guidelines and Directives

18. Implement eCTD • Implement eCTD as standard for e-submission across product lifecycle: • When signed off at step 4 • Collaboration between agencies and industry • Agencies to develop internal review environments • Support eCTD with EU legislation • Encouraging e-submission • Removing need for paper copy of submission • Develop single EU submission repository • Develop new aspects of eCTD in collaboration with industry (e.g. manage CMC as dynamic data)

19. Other Benefits of Dynamic Data Exchange and Management • Dossier content always up-to-date • Provides transparency of information • Provides resource savings and efficiencies • Up-to-date information for better decision making, e.g. • Manufacturing inspections • Eliminates or speeds up administrative steps • Tackles common business problem for industry and agencies

20. Single EU ADR Database • Single EU repository for product AE data • Single point of submission • Single data set for safety profile • Up-to-date information for better decision making, e.g. • Protection of public health • Provides resource savings and efficiencies • Tackles common business problem for industry and agencies • Facilitates PSUR creation and submission

21. EFPIA IT ProposalsConclusions (1) • Progress towards future IT implementation • Realise benefits • Support EU Expansion • Improve Pharmaco-vigilance system • Bring products more quickly to patients • Enhance competitiveness of EU Regulatory Procedures

22. EFPIA IT ProposalsConclusions (2) • Progress towards future IT implementation • Industry and Agencies work together • shared benefits • shared steering committees and task forces • Require clear commitment to ongoing and future projects • agency business and IT resources • Support changes with legislation • remove the need for paper INDUSTRY WILL PLAY OUR PART