Specific guidelines requirements for clinical trials with Advanced Therapy Medicinal Products in the EU
Aurélie Mahalatchimy
(1)
,
Éloïse Gennet
(1)
,
Michael Morrison
(2)
,
Véronique Andrieu
(3)
,
Julie Veran
(4)
,
Florence Sabatier
(5)
1
DICE / CERIC -
Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
2 HeLEX - Centre for Health, Law and Emerging Technologies
3 MEPHI - Microbes évolution phylogénie et infections
4 APHM - Assistance Publique - Hôpitaux de Marseille
5 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
2 HeLEX - Centre for Health, Law and Emerging Technologies
3 MEPHI - Microbes évolution phylogénie et infections
4 APHM - Assistance Publique - Hôpitaux de Marseille
5 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
Aurélie Mahalatchimy
- Fonction : Auteur
- PersonId : 18844
- IdHAL : aurelie-mahalatchimy
- ORCID : 0000-0002-4365-2143
- IdRef : 172268745
Éloïse Gennet
- Fonction : Auteur
- PersonId : 999043
- IdRef : 234643447
Michael Morrison
- Fonction : Auteur
- PersonId : 1165398
Florence Sabatier
- Fonction : Auteur
- PersonId : 958995
Résumé
Advanced Therapy Medicinal Products (ATMPs), a European legal classification of medicinal products based on genes, cells and tissues, raise specific issues in the context of clinical trials. In comparison to more traditional medicinal products, ATMPs have been subject to specific regulatory provisions in the European Union (EU) since Regulation (EC) n°1394/2007. Yet for the clinical trials with ATMPs, the general regime laid out in Regulation 536/2014 on clinical trials (which came into effect on 31 January 2022) applies, together with the ICH E6 Guidelines on Good Clinical Practice (GCP). For clinical trials conducted in the EU, compliance with GCP is mandatory. The European Commission has also adopted and published 2019 Guidelines on GCP specific to ATMPs, as required by Article 4 of Regulation (EC) n°1394/2007 on ATMPs. These guidelines both adapt the ICH guidelines to ATMPs’ characteristics and provide additional measures that have been considered necessary. However, they are not exhaustive as they explain only some specificities of ATMPs and they remain complementary to the general rules. After having analysed these documents, we will highlight the specificity of requirements for investigational ATMPs in order to reveal the specific challenges they are addressing and why these challenges warrant separate regulation in order to obtain clinical trials’ authorisation for investigational ATMPs.
Domaines
DroitFormat du dépôt | Fichier |
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Type de dépôt | Poster de conférence |
Titre |
en
Specific guidelines requirements for clinical trials with Advanced Therapy Medicinal Products in the EU
|
Résumé |
en
Advanced Therapy Medicinal Products (ATMPs), a European legal classification of medicinal products based on genes, cells and tissues, raise specific issues in the context of clinical trials. In comparison to more traditional medicinal products, ATMPs have been subject to specific regulatory provisions in the European Union (EU) since Regulation (EC) n°1394/2007. Yet for the clinical trials with ATMPs, the general regime laid out in Regulation 536/2014 on clinical trials (which came into effect on 31 January 2022) applies, together with the ICH E6 Guidelines on Good Clinical Practice (GCP). For clinical trials conducted in the EU, compliance with GCP is mandatory. The European Commission has also adopted and published 2019 Guidelines on GCP specific to ATMPs, as required by Article 4 of Regulation (EC) n°1394/2007 on ATMPs. These guidelines both adapt the ICH guidelines to ATMPs’ characteristics and provide additional measures that have been considered necessary. However, they are not exhaustive as they explain only some specificities of ATMPs and they remain complementary to the general rules. After having analysed these documents, we will highlight the specificity of requirements for investigational ATMPs in order to reveal the specific challenges they are addressing and why these challenges warrant separate regulation in order to obtain clinical trials’ authorisation for investigational ATMPs.
|
Auteur(s) |
Aurélie Mahalatchimy
1
, Éloïse Gennet
1
, Michael Morrison
2
, Véronique Andrieu
3
, Julie Veran
4
, Florence Sabatier
5
1
DICE / CERIC -
Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
( 199942 )
- Espace Cassin, 3 Av Robert Schuman 13628 AIX EN PROVENCE CEDEX 1
- France
2
HeLEX -
Centre for Health, Law and Emerging Technologies
( 567410 )
- Royaume-Uni
3
MEPHI -
Microbes évolution phylogénie et infections
( 527038 )
- IHU Méditerranée Infection
19-21 Bd Jean Moulin
13005 Marseille
- France
4
APHM -
Assistance Publique - Hôpitaux de Marseille
( 300073 )
- Direction générale AP-HM
80, rue Brochier
13 354 Marseille Cedex 5
- France
5
C2VN -
Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
( 1002339 )
- Faculté de Médecine de la Timone 27 boulevard Jean Moulin 13385 MARSEILLE CEDEX 5
- France
|
Date de publication |
2022
|
Volume |
33
|
Numéro |
23-24
|
Page/Identifiant |
A197-A197
|
Date fin congrès |
2022-10-14
|
URL du congrès ou éditeur |
https://www.esgct.eu/Events/Upcoming-events.aspx
|
Langue du document |
Anglais
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Invité |
Non
|
Audience |
Internationale
|
Actes |
Non
|
Titre du congrès |
European Society for Gene & Cell Therapy Congress 2022
|
Date début congrès |
2022-10-11
|
Ville |
Edinburgh
|
Pays |
Royaume-Uni
|
Éditeur commercial |
|
Projet(s) ANR |
|
Financement |
|
Domaine(s) |
|
Origine :
Fichiers produits par l'(les) auteur(s)
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