EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Molecular Therapy. Methods & Clinical Development
Giulia Detela, Anthony Lodge

Abstract

Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency's Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission. In common with other medicinal products, various regulatory pathways are available for taking ATMPs through clinical trials to market authorisation, and the regulatory pathway taken will depend on a product's characteristics and the target patient population. With the industry poised to deliver more late-stage clinical and commercial ATMPs for serious diseases with high unmet medical need (e.g., T cell immunotherapies for cancer), bringing medicines to patients through optimized regulatory strategies and expedited pathways is assuming greater importance. The European Medicines Agency's priority medicines (PRIME) scheme was introduced in 2016 specifically to enable this, and eligibility has been granted to 19 ATMPs as of the fourth quarter (Q4) 2018. Furthermore, two chimeric antigen receptor (CAR) T cell therapies, Yescarta and Kymriah, have recently completed their journeys through the scheme to Marketing Authorisation. This review discusses how the regulatory pathway for any parti...Continue Reading

Citations

Mar 30, 2019·Paediatric Anaesthesia·Victor C BaumMichiyo Sakiyama
Mar 13, 2019·Tissue Engineering. Part a·Liesbet Geris, Ioannis Papantoniou
Nov 13, 2019·Der Hautarzt; Zeitschrift für Dermatologie, Venerologie, und verwandte Gebiete·Johannes Wohlrab
Jan 4, 2020·BMJ : British Medical Journal·Sophie CooperNick Crabb
Nov 7, 2019·Applied Health Economics and Health Policy·Caridad PontesBrian Godman
Nov 11, 2019·Clinical Pharmacology and Therapeutics·Martina Schuessler-LenzSpiros Vamvakas
Jul 29, 2020·Therapeutic Innovation & Regulatory Science·Belkis Romeu, Rafael Perez Cristiá
Sep 24, 2019·Frontiers in Pharmacology·Carolina Iglesias-LópezAntonio Vallano
Apr 23, 2020·Frontiers in Bioengineering and Biotechnology·M Adelaide AsnaghiIvan Martin
Aug 25, 2020·Science Advances·Oren LevyJeffrey M Karp
Jun 17, 2020·The Journal of International Medical Research·Carlo AstaritaLetizia Trovato
Aug 15, 2020·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Doug CoyleKoonal Shah
Jan 8, 2020·Tissue Engineering. Part B, Reviews·Caroline Veronique OberweisPatricia Gálvez-Martín
Nov 4, 2020·British Journal of Pharmacology·Rachele CiccocioppoFranco Locatelli
Jan 5, 2021·Frontiers in Cell and Developmental Biology·Roya RamezankhaniEnsiyeh Hajizadeh-Saffar
Nov 27, 2020·Drug Discovery Today·Eline van OverbeekeSteven Simoens
Nov 17, 2020·Frontiers in Plant Science·Daniel TuséJohannes Felix Buyel
Dec 29, 2020·Acta Ophthalmologica·Daniele SpinozziSilke Oellerich
Mar 24, 2021·Gene Therapy·Nawid AlbingerEvelyn Ullrich
Sep 13, 2020·Journal of Pharmaceutical Sciences·Michaela SharpePanos Kefalas
Apr 4, 2021·Pharmaceutics·Marina López-PaniaguaTeresa Nieto-Miguel
Apr 29, 2021·Drug and Therapeutics Bulletin·Kayleigh Kew
Jan 29, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P ComoliUNKNOWN European Society for Blood and Marrow Transplantation, Cellular Therapy & Immunobiology Working Party – Solid Tumor Sub-comm
Aug 25, 2021·Journal of Comparative Effectiveness Research·Anna KaltenboeckSteven D Pearson

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Methods Mentioned

BETA
genetic modification

Software Mentioned

Holoclar
PRIME
TEMCELL
Imlygic
RMAT
Yescarta
Pluristem
Spark
MAA
Spherox

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