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Overview of the Regulation of
Advanced Therapy Medicinal
Products (ATMP) in the EU
Christopher A Bravery
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Tissues / Cells2004/23/EC
Medicinal
ProductsCommunity Code
Dir. 2001/83/EC
Medicinal
ProductsCentralised procedure
Reg. (EC) 726/2004
Other starting
materials
Clinical Trials2001/20/EC
GMP2003/94/EC
Blood2002/98/EC
Variations1084/2003/EC
1085/2003/ECRegulation
1394/2007
EU Regulatory FrameworkCompletion of the bigger picture
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‘Annex I’2009/120/EC
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Annex I Ammendment
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2.2. Somatic cell therapy medicinal product
Somatic cell therapy medicinal product means a biological medicinal
product which has the following characteristics:
(a) contains or consists of cells or tissues that have been subject
to substantial manipulation so that biological characteristics,
physiological functions or structural properties relevant for the intended
clinical use have been altered, or of cells or tissues that are not
intended to be used for the same essential function(s) in the recipient
and the donor;
(b) is presented as having properties for, or is used in or
administered to human beings with a view to treating, preventing or
diagnosing a disease through the pharmacological, immunological or
metabolic action of its cells or tissues.
Somatic Cell Therapy
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Certification Procedure
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Only open to micro, small and medium-sized
enterprises (SME’s, as defined 2003/361/EC)
developing ATMP/s and established in the
Community.
Provide Quality with or without Non-clinical data.
Evaluation by the CAT in 90 days.
Option for clock stop to request further data.
Possibility of a site visit.
Combination products should take into account the
opinion of a Notified Body.
More than one certification is possible.
Certification Procedure
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The CAT is Born
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The CAT is now Operational
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The CAT is now Operational
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CAT Announces Positive Opinion
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CAT Announces First Classification
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Classifications
First Classifications
published on the
EMEA website.
http://www.emea.europa.eu/htms/human
/advanced_therapies/recommendations.
htm
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13
Interested Parties to the CAT
First Meeting Held
11 Sept 2009
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CAT Statistics to October 2009
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CAT Statistics to October 2009
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Guidance on Certification
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Assessment Team 1 Assessment Team 2
CAT-CHMP Assessment Teams
Normal CHMP Assessment Team
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Assessment Team 1 Assessment Team 2
CAT-CHMP Assessment Teams
ATMP CHMP Assessment Team
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10
Assessment Team 1 Assessment Team 2
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Peer review
review by 1 CHMP
member ≥1 CAT
member(s)
CHMP Coordinator (s)responsible for flow of
information between
CAT & CHMP
+ discussion/ adoption of opinion at CHMP
CAT (Co)Rapp coordinate procedure &
discussions at CAT
+ prepare draft opinions
and assessment reports
ATMP CHMP Assessment Team
CAT-CHMP Assessment Teams
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Day 80AR
Day 121
Response
Day 170LoOI
Day 171Grounds for approval/
refusal transmission to CHMP
*Day 180CHMP
discussion
on grounds for approval/
refusal
CHMP
appoints
assessment
teams
Day 0Start
Day 120LoQ
Day 150AR
Day 171CAT OE
**Day 210CHMP
discussion
& decision
on need
for LoOIand/or OE
CHMP
Comments
CHMP
Comments
(CHMP
highlights
divergence)
AR – Assessment report
LoQ –List of Questions
LoOI – List of Outstanding Issues
OE – Oral
Explanation
CAT-CHMP Assessment of MAA
Day 181
Response
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CONCLUSIONS
►The essential enacting Legislation is all
now in place
►The CAT is formed and active
►Scientific Advice
►Scientific Classifications
►First positive opinion
►First Certification submitted
