CD34 numeration through the French external quality control: Impact

CD34 numeration through the French
external quality control:
Impact in the implementation of new
technical chapters at the European
Pharmacopoeia
Panterne Béatrice
Cells and Tissues Coordinator
Batch release and market surveillance for biological products
Department(LISBIO)
CTROL Division
26/04/14
ISCT Paris

1Agence nationale de sécurité du médicament et des produits de santé
Summary
General missions of ANSM
External quality control of cell therapy products
Method Validation
CD34+ numeration results
Through the External Quality Control campaign
Through a Cord Blood Multicentric Study
Monograph proposal at the European Pharmacopoeia
« Cell Therapy Products » Working group
2.7.23 technical chapter for CD34+ cell numeration
Conclusion

2Agence nationale de sécurité du médicament et des produits de santé
December
December 29th 2011 29th 2011 law law
Related to the reinforcement of the drug and health
product safety
ANSM
ANSM Creation Creation
Implementation
Implementation 2012, the 1 2012, the 1st
st of May
of May
•Public establishment on the authority of the Ministry of health
•Resumption of the missions, responsabilities, and competences
exercised by the AFSSAPS
•Introduction of new functions consolidation of the health system
General Presentation of ANSM
New
New organization organization, , 2012, the 1 2012, the 1st
st of
of October October

3Agence nationale de sécurité du médicament et des produits de santé
•Participation in the development of "... laws and regulations in the
manufacture, preparation, conservation or utilization (...)". health
products for human. "(Articles L.5311 - 1 and L.5311 - 2 of the Code of
Public Health)
•Health Safety Mission
Laboratories Control Division (CTROL)
French « Official Medicines Control
Laboratories » (OMCL)
Assessment
Inspection
Information
Control
ANSM Missions

4Agence nationale de sécurité du médicament et des produits de santé
Cells and CTP
Subsequent
Subsequent product product regulatory regulatory
First grafts of bone marrow in the 60’s
1
1st
st law
law of of bioethic bioethic (1994) (1994)
July 1998 Law
July 1998 Law
Afssaps creation = competent authority
Organs, tissues, cells = health products
October
October 2001 2001 decree decree and and February February 2003 2003 order order
Etablishment
Etablishment Authorisation Authorisation Products Products Authorisation Authorisation
after preparation process process and indication evaluation evaluation
(quality, efficacy and safety)
September
September 2008 2008 decree decree and and october october 2011 2011 order order
29 December 2011 law ANSM Creation