Workshop on e-submissions in the veterinary sector Neil Paterson, David Lewsey and Alex Tait Veterinary Medicines Directorate, UK A proposal for electronic submission for veterinary medicines

Outline of presentation  Why electronic submissions  Proposals for veterinary e-submissions  using bespoke software  using ‘standard’ software  Conclusions  Next steps

Why electronic submissions  Industry request to HMA  Benefit to both regulators and industry  reduction of administrative burden (paper)  reduction of storage space  facilitation of assessment and review process  product lifecycle management  Accept e-submission by 1 Jan 2010

VMD proposal for e-submissions  Based on common sense  Simple system based around way things work now  Builds on specification agreed by industry and regulators  Suitable for companies of all sizes

E-submission using bespoke software  For reviewers based on EURS is Yours  Basic structure based on NTA (eNTA)  Natural evolution from paper to electronic format  Lifecycle management built in  Granularity  only 3 levels

E-submission using bespoke software  eNTA structure  Example from Part III of dossier for a pharmaceutical product

APPENDIXOnly be present in the version used by regulators. Depository for all information which is submitted during the assessment of an application The place for variation and renewal applications. At the end the applicant would provide an updated replacement for all of the above sections of the dossier? Part 3SAFETY AND RESIDUES TESTS 3.ASafety Tests 3.A.1Precise identification of the product and of its active substance(s) 3.A.2Pharmacology 3.A.3Toxicology 3.A.4Other requirements 3.A.5User safety 3.A.6Environmental risk assessment 3.BResidue Tests 3.B.1Introduction 3.B.2Metabolism and Residue Kinetics 3.B.3Residue Analytical method

E-submission using ‘standard’ software  An electronic submission but not eNTA  A VNeeS based on an agreed standard  Structure still in line with NTA  Lifecycle management as for paper  Granularity  2 levels

E-submission using ‘standard’ software  NTA structure  Same example from Part III of dossier for a pharmaceutical product

APPENDIXOnly be present in regulators version. Repository for information produced during the assessment of the dossier Part 3SAFETY AND RESIDUES TESTS 3.ASafety Tests 3.BResidue Tests

VNeeS  Advantages  same as already doing with paper  an interpretation of the already agreed specification for electronic dossiers  potential for import into EURS is Yours  simple structure  For example

VNeeS requirements PaperVNeeSAgreed spec Adequate identificationeach PDF has name not number the name of the files should be descriptive An index for the whole submission a full index in each PDF a well structured dynamic TOC Binders no more than 300 sheets each PDF a maximum of 20 MB each PDF no larger than 100 MB

Conclusions  A single EU solution to e-submissions is needed  Can be used by all  Natural evolution from paper  Adaptability  Choice and flexibility  VMD believe it will work

Next steps  Breakout sessions  Harmonisation of requirements  Validation criteria  Previous experience of e-submissions  Assistance to industry (e.g. SMEs)

Next steps  Early decision – end May?  VMD willing to discuss with all  VMD will begin to draft a guidance for VNeeS

The Future  Agreement now does not mean no changes  Systems can and probably will evolve over time  The proposal is the roadmap

Thank you for your attention Have to be ready on 1 January 2010