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Specific rules regarding the authorisation, supervision and pharmacovigilance of ATMPs

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Advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process (Title II of Directive 2001/83).

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EXCLUDED from the scope of this Regulation:

advanced therapy medicinal products which are prepared on

ƒ a non-routine basis according to specific quality standards,

ƒ used within the same Member State in a hospital,

ƒ under the exclusive professional responsibility of a medical

practitioner in order to comply with an individual medical prescription for a custom made product for an individual patient

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For products within the scope:

• Marketing authorisation required

• Demonstration of Quality, Safety & Efficacy

• Post-authorisation vigilance of S & E

• Centralised procedure mandatory

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EL EL PROCEDIMIENTO CENTRALIZADO PROCEDIMIENTO CENTRALIZADO

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• INICIO DEL PROCEDIMIENTO

• DISTRIBUCION DE INFORMES DE EVALUACION

• COMENTARIOS MIEMBROS CHMP

• LISTA CONSOLIDADA DE OBJECIONES

• CHMP VALIDACION DE OBJECIONES.

• RESPUESTAS DE LA COMPAÑÍA

• INFORME COMUN PARA EL CHMP

• COMENTARIOS DEL CHMP AL INFORME

• DEBATE DEL CHMP DECISION DE AUDIENCIA

0

100 115 120 80

170 180 121 150

SOLICITUD A LA EMEA:

CALENDARIO DE EVALUACION

DIA

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EUROPEAN MEDICINES

AGENCY

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www.ema.europa.eu

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COMITÉS CIENTÍFICOS

CVMP

CHMP COMP HMPC

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COMITÉS CIENTÍFICOS

CHMP

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www.ema.europa.eu/humandocs/Humans/EPAR/chondrocelect/chondrocelect.htm

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CTD Modules

No. of modules : 5

* Module 1 - Regional Information

* Module 2 – Quality overall summary Nonclinical overview

Clinical overview

Nonclinical written summaries Clinical summaries

* Module 3 - Quality

* Module 4 – Safety (Nonclinical)

* Module 5 – Efficacy (Clinical)

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http://www.ema.europa.eu/htms/human/ich/ichmulti.htm

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• 5 CHMP members (co-opted or not) with their alternates (from the MS or identified by the CHMP)

• 1 M (1A) per MS from MS not represented through CHMP

• 2 M (2A) representing clinicians

• 2 M (2A) representing patients’ associations

• Should include at least 2 M (2A) with expertise in MD

• List of expertise: medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics

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Expertise within CAT members

Declared expertise as of 15

Declared expertise as of 15--1212-08-08

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‰

Chondrocelect

(autologous chondrocytes):

marketing authorization granted (July 2009)

‰ Cerepro

(AdV-HSVtk): negative opinion on the second marketing authorization application

‰ Advexin

(AdV-p53): withdrawn by the applicant before the final opinion

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Based on Regulation (EC) No 141/2000

May be obtained at any stage of development

No fees

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• AAV vector expressing lipoprotein lipase - lipoprotein lipase deficiency

• AdV – HSV-tk gene - high-grade glioma (+ ganciclovir sodium)

• HSV-tk and truncated low affinity NGFR transfected donor lymphocytes - haematopoietic cell transplantation

• Autologous CD34+ cells transfected with a RV vector - ADA gene - SCID due to ADA deficiency

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http://www.emea.europa.eu/htms/human/mes/itf.htm

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