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

APPENDIX Only 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 3 SAFETY AND RESIDUES TESTS

3.A Safety Tests

3.A.1 Precise identification of the product and of its active substance(s)

3.A.2 Pharmacology

3.A.3 Toxicology

3.A.4 Other requirements

3.A.5 User safety

3.A.6 Environmental risk assessment

3.B Residue Tests

3.B.1 Introduction

3.B.2 Metabolism and Residue Kinetics

3.B.3 Residue 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

APPENDIX Only be present in regulators version. Repository for information produced during the assessment of the dossier

Part 3 SAFETY AND RESIDUES TESTS

3.A Safety Tests

3.B Residue 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

Paper VNeeS Agreed spec

Adequate identification each 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