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Q3. Will the cells be Genetically Modified?

Interim UK Regulatory Route Map for Stem Cell Research & Manufacture Version: 24.06.09. Start Here. Key:. Q1. Are the stem cells intended for Human Application? Discuss with HTA. Post-marketing Surveillance of Stem Cell ATMP. Positive Opinion of EMEA: Marketing Authorisation Granted.

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Q3. Will the cells be Genetically Modified?

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  1. Interim UK Regulatory Route Map for Stem Cell Research & Manufacture Version: 24.06.09 Start Here Key: Q1. Are the stem cells intended for Human Application? Discuss with HTA Post-marketing Surveillance of Stem Cell ATMP Positive Opinion of EMEA: Marketing Authorisation Granted NO YES Regulatory Question Research or Manufacturing Activity Submission to EMEA Apply for HTA License Q2. Will the stem cells be derived from Human Embryo? Preparation of Regulatory Dossier for EMEA Statutory RegulatoryProcess Non-StatutoryGood Practice Q2. Will the stem cells be derived from Human Embryo? NO YES Quality, Safety & Efficacy Data Generated Possible applications to REC & for HTA License Discuss with HTA Submissions to: (i) HFEA,(ii) REC, & (iii) NHS R&D Office NO YES Safety reporting to Regulatory Agencies Possible Submissions to REC & NHS R&D Office Submissions to: (i) HFEA,(ii) REC, & (iii) NHS R&D Office Stem Cell Clinical Trial Generation of Stem Cell Line Generation of Stem Cell Line Serious Adverse Event & Reactions Reporting to HTA HSE Notification may be needed NO YES Generation of Stem Cell Line Deposition in UK Stem Cell Bank via Steering Committee In vitro Stem Cell Research Q7. Will the clinical research involve gene therapy? Clinical Stem Cell Research Q3. Will the cells be Genetically Modified? Deposition in UK Stem Cell Bank via Steering Committee Submissions to: (I) MHRA Clinical Trials Unit, (ii) GTAC, & (iii) NHS R&D Office In vitro Stem Cell Research Submissions to NHS R&D Office & REC (Non-statutory good practice for studies outside the NHS) NO YES Q3. Will the cells be Genetically Modified? Preparation of Clinical Trial documentation & obtain EudraCT number In vitro Stem Cell Research HSE Notification may be needed NO YES In vitro Stem Cell Research Q3. Will the cells be Genetically Modified? Manufacture unlicensed product Stem Cell Research in Animals Manufacture Clinical Trial product Stem Cell Research in Animals HSE Notification may be needed NO YES Q7. Is animal in vivo workrequired? In vitro Stem Cell Research HSE Notification may be needed Home Office Approval Create MCB/WCB Create MCB/WCB Home Office approval & safety study under GLP Q7. Is animal in vivo workrequired? NO YES In vitro Stem Cell Research GMP licence from MHRA GMP licence from MHRA NO YES Home Office Approval NO YES Q4. Will the stem cells be manufactured into a Medicinal Product or Investigational Medicinal Product? If yes, they will be regulated as an ATMP. Discuss with MHRA/EMEA Q6.Is animal in vivo work required? NO YES Stem Cell Research in Animals Home Office Approval Q5. Is the product to be licensed? Dialogue with MHRA Stem Cell Research In Animals NO YES

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