workshop on e-submissions in the veterinary sector
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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
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