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Safeguarding public health
Meet the Regulators MHRA, London
13 April, 2011
LRMN/ MHRA MEETING
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ATMPs - the regulatory setting
Marketing Authorisationcentralised licence (MA)
(CAT) EMA
CommercialClinical TrialsPhase I, II, III
Pre-clinical
Safety
Clinical Trialsnational licence (CTA)
NCA
EUTCDor
Blood Directive
Donation, procurement
& testing (processing)
Unlicensed (Hospital Exemption / Specials)
Cert. of Quality & non-clinical data
EMA
GP GMPMIA(IMP)
GMP
GMPMIA
GLP
DossierDossier
Transplants or TransfusionsProcessing, preservation, storage, distribution
GP
Borderline – classification of product: medicinal product?
Dossier
Advice and guidance NCA / EMA
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Presentation Outline
• Abbreviation glossary
• ATMPs – the regulatory setting
• Useful links
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Abbreviation Glossary
• ATMP - Advanced Therapy Medicinal Product (GT, SCT, TEP)
• CAT - Committee for Advanced Therapy
• EMA - European Medicines Agency
• EUTCD - EU Tissue and Cells Directive (2004/23/EC)
• GP - Good Practice (Quality System under Blood & EUTCD)
• GT - Gene Therapy
• NCA - National Competent Authority (e.g. MHRA)
• SCT - Somatic Cell Therapy
• TEP - Tissue Engineered Products
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Inspectorate contact with ATMP Industry
• Regulatory advice on manufacturing :- Verbal- Written- Meetings – GMP only / with CTU / with Licensing Division
• Inspections:- Hospital Exemption - Manufacturer’s Specials- CT - MIA(IMP) - Full - MIA
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Inspectorate contact with ATMP Industry
• Formal classification advice:
- Available from EMA and via MHRA website
- MHRA’s centralised process been in place for 3 years:
Year No.· 08/09: 8· 09/10: 24· 10/11: 13
- System been well received- Advice requests received on a broad range of product types
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Inspectorate contact with ATMP Industry
• DH initiatives
- Stem Cell Tool Kit
• Commission / ATMP Regulation :
- Article 5 (Annex 2)
- Article 25 (Report and review)
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Useful links
• EMA – What’s new in Inspections:- http://www.emea.europa.eu/Inspections/WhatsNew.html
• Commission ‘Latest News on Pharmaceuticals’:
- http://ec.europa.eu/health/documents/new_en.htm
• GMP Volume 4:- http://ec.europa.eu/health/documents/eudralex/index_en.htm
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Scientific Advice (National) for ATMP Scientific Advice (National) for ATMP 2009 - present2009 - present
Safeguarding public health
CTMPCTMP GTMPGTMP
20092009 5 3
20102010 5 1
20112011(to Mar)(to Mar)
2 0
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1. Characterisation and Impurities
2. Mechanism of Action and Potency Testing
3. Demarcation of Drug Substance and Drug Product
Recurring issues for CTMP:Recurring issues for CTMP:
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Safeguarding public health
Advanced Therapy Medicinal Products: EU procedures
LRMN 13 April 2011
Patrick Celis, PhDCAT Secretariat, EMA, London
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CLASSIFICATION
EVALUATION
CERTIFICATION
Tasks of the CATTasks of the Committee for Advanced Therapies (CAT)
Scientific Advice
Support to PDCO
Support to CHMP / COMP
Interaction with
stakeholders
Publications, Guidelines
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ATMP Evaluation procedure
ATMPs will follow the Centralised procedure (mandatory scope) single MA (marketing authorisation) for entire EU: • 210 Day procedure• Evaluation by two independent (Rapp/CoRapp) teams from CAT• All scientific discussion and adoption of key documents at CAT
ATMP evaluation procedure builds on full transparancy between CAT and CHMP to avoid divergent views.* CHMP = Committee for Human Medicinal products. Responsible for opinion on centralised
MAA + post-authorisation follow-up / Pharmacovigilance
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Classification procedure
• Incentive • Open to all applicants • Scientific Recommendation from CAT on the Regulatory
Classification of their ATMP• 60-day procedure (often shorter)• Publication of summary information on classification• Procedure reviewed (simplified) following experience in
2009
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Classification procedure
44 applications received so far42 finalised• Within 60 days • 4 out of 42: 1 month clock stop
for clarifications
(Status April 2011)
Outcome
10
15
13
1 3
GTMP CTMP TEP
ATMP Not ATMP
GTMP
Not ATMPATMP
TEP
CTMP
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Certification procedure
• Only for SMEs• Scientific evaluation by CAT of
- (early) quality / development data (Module 3)- (early) non-clinical data (Module 4)
• 90 day procedure• Evaluation to the scientific standards of a MAA
- The SME applicant will always received the evaluation report (and List of issue for future consideration)
- If positive evaluation: Certificate by EMA • 1 Certification procedure finalised (May 2010)
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Source: CAT monthly report March 2011
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Thank you for your attention
Dr Patrick Celis (CAT Secretariat)[email protected]+44 207 418 8656
Queries: [email protected] Microsite: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800241e0
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CAT workprogramme 2010-201519
Useful links
Developers
CAT
MHRA information on ATMPshttp://www.mhra.gov.uk/Howweregulate/Advancedtherapymedicinalproducts/index.htm
EMA information on Advanced Therapieshttp://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800241e0&jsenabled=true
European Commission’s Directorate for public health and risk assessmenthttp://ec.europa.eu/health/human-use/advanced-therapies/index_en.htm
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Useful links
Developers
CAT
CAT Work programme 2010-2011http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2010/11/WC500099029.pdf
CAT Interested Parties and Focus Group Non-Clinical developmenthttp://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000309.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058009a23d&jsenabled=true
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Contacts for further information
MHRADr Gopalan Narayanan - [email protected] Ian Rees - [email protected] Elaine Godfrey - [email protected] EMA CAT Secretariat Dr Lucia D’Apote - [email protected]