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Pre-Clinical Discovery List view
Pre-Clinical Development List view Clinical Development List view
Clinical Development - List view
Bottlenecks in the process are marked with a B.
All are standard proces unless stated otherwise.
Clinical Development
- Lead products
- Go/No go decision to enter clinical development (Essential Go/No Go step)
- Vaccine safety testing – Safety management planning
- Regulatory and ethics engagement – Seek advice and approvals
- Manufacturing – Pilot manufacturing
- Commercial considerations – Initial commercial assumptions
- Comparability of Assay results – Immunogenicity assays
- Review TPP
- Clinical study design
- Required at this stage -
- Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
- Vaccines classified as GMOs (Essential Go/No Go step) B
- Phase 1 clinical trial
- International trial?
- Availability of trial sites B
- NRA Approval (Essential Go/No Go step)B
- Results assessment
- Safety/ immunogenicity data
- Lead indication confirmed
- Vaccine safety testing – Safety reporting
- Regulatory and ethics engagement – Seek advice and approvals
- Manufacturing – Manufacturing scale-up
- Commercial considerations – Input from commercial
- Comparability of Assay results – Immunogenicity assays
- Review TPP
- Clinical study design
- Required at this stage -
- Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
- Vaccines classified as GMOs (Essential Go/No Go step) B
- Phase II clinical trial
- Commercial Licensure )based on MHRA/EAMS) – PIM designation awarded
- Commercial Licensure )based on MHRA/EAMS) – Scientific review for EAMS based on Phase III data
- Commercial Licensure )based on MHRA/EAMS) – MHRA opinion issued
- Commercial Licensure )based on MHRA/EAMS) – Prescribing possible prior to EMA opinion
- Scientific advice (Regulatory and HTA)
- Full clinical development decision (Essential Go/No Go step)
- Ongoing from this point –
- Vaccine safety testing – Prepare safety documents
- Regulatory and ethics engagement – Seek scientific/regulatory advice
- Manufacturing – Process validation
- Commercial considerations – Commercial development
- Comparability of Assay results – Immunogenicity assays
- Review TPP
- Clinical study design
- Required at this stage -
- Ethical and regulatory approval, including HRA if required (Essential Go/No Go step) B
- Vaccines classified as GMOs (Essential Go/No Go step) B
- Phase III clinical trial
- Compile and publish Dossier for submission
- Market access application begins
(A to E ongoing until after Phase 1 clinical trial – Step 6 below)
(A to E ongoing until Scientific advice – Step 14 below)
Manufacturing at scale
(A to D ongoing in parallel with Steps 9 to 18 until Market access application begins – Step 18 below)
(A to E ongoing until after Phase III clinical trial – Step 16 below)
End of Process