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Federal Office for Safety in Health Care www.basg.gv.at
Update on investigational ATMP guideline
Ilona Reischl, PhD BASG/AGES - Federal Office for Safety in Health Care Austrian Agency for Health and Food Safety Traisengasse 5, 1200 Vienna, Austria
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§ The practical application of the Clinical Trials Regulation has been delayed to Q2 2019
§ We have been working on the Guideline for investigational ATMPs since the beginning of 2016
§ National clinical trials assessors had been invited via the CTFG and have been participating in the drafting activities
Update Where are we now
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Development of a guideline on Investigational ATMPs § Initiate development of guideline – external consultation in Q4 2016 § Finalise guideline after external consultation - completion Q2 2017
§ We are clearly delayed § What are the reasons?
CAT Workplan 2016 Timelines
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The guideline has not been sent out for comments yet Why? § Efforts spent on GMP for ATMPs § Finalisation of the Guideline on quality, non-clinical and clinical
aspects of gene therapy medicinal products à Adoption Q1 2018
§ Alignment issues – which content goes into which guidance document
§ Limitation of resources
Update Where are we now
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What kept us busy? Now published
EudraLex The Rules Governing Medicinal Products
in the European Union Volume 4 Good Manufacturing Practice
Guidelines on Good Manufacturing Practice specific to Advanced
Therapy Medicinal Products
http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?newsletter_service_id=327&newsletter_issue_id=6070&page=1&fullDate=Wed%2022%20Nov%202017&lang=default https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
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§ Revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.
§ Publication of the draft of the revised Guideline for external
consultation by 1Q 2018 § Finalise the Revision of the Guideline by 4Q 2018 § CAT will collaborate with the BWP for the revision of the quality
part of this guideline.
CAT Workplan 2017 Revision of ATMP specific guidelines
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§ The initial plan of developing a Guideline on comparability of cell-based medicinal products has been changed, instead the format of a Q&A document is considered as better suitable
Why? § There are already general texts in all documents (for cell- and
gene therapies), including in the guideline for investigational ATMPs
§ The general principles in ICH Q5E apply § For case-by-case explanations a Q&A is better suited
Comparability Format of guidance
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§ Alignment with current EMA guidance and taking into consideration guidance from other agencies
§ Intended applicability for all ATMPs, coverage of quality, non-clinical and clinical aspects
à specific drafting groups
§ Main focus is on minimal requirements for early clinical trials, but guidance for later development will also be included
§ Differentiation between exploratory and pivotal clinical trials rather than phases
iATMP Content Unchanged
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§ Text for cell-based and gene therapy products is drafted separately and will be brought together at a later stage
§ Existing GL on non-clinical requirements for gene therapy products will be incorporated
§ Considerations for combination products will be included
Content Unchanged
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Next drafting group meeting 6.12.2017 – joint meeting § Cell based products - quality – close to first draft § Gene therapy - quality – wait for finalisation of GT GL § Preclinical – first draft ready § Clinical – first draft ready The individual first drafts will be completed and compiled. There will be a need for alignment.
iATMP Status quo
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Development of a guideline on Investigational ATMPs § Discuss with developers (interested parties) the key aspects on
which they would like to have regulatory clarification on. • Deadline: 2Q 2018
§ Publication of the draft of the Guideline for external consultation in Q4 2018
§ Finalise guideline after external consultation - completion Q3 2019
CAT Workplan 2018 Timelines
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Federal Office for Safety in Health Care www.basg.gv.at
Thank you for your attention!
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