Update on EMA’s procedural advice on classification of ATMPs
Today, from Revio, we would like to inform you that the European Medicines Agency has published the Revision 2 of the “Procedural advice on the provision of scientific recommendation on…
Draft Guidance on Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical trial
Today, from Revio, we would like to share with you a summary of the Food and Drug Administration (FDA) draft Guideline on Studying Multiple Versions of a Cellular or Gene…
Plasmids and GMPs requirements
Today, from Revio, we would like to share with some information on the regulatory framework regarding plasmids and Good Manufacturing Practices (GMPs) to help in the development of ATMPs that…
Draft Guideline on core SmPC, Labelling and Package Leaflet for ATMPs containing genetically modified cells
Today, from Revio, we would like to inform you that the European Medicines Agency recently published for public consultation a draft Guideline on core SmPC, Labelling and Package Leaflet for…
Expedited programs for regenerative medicine therapies for serious conditions
Today, from Revio, we would like to share with you a review on a piece of guidance from the Food and Drug Administration (FDA): Expedited Programs for Regenerative Medicine Therapies…
Draft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products
Today, from Revio, we would like to share with you a summary of the International Council for Harmonisation (ICH) guideline about nonclinical biodistribution considerations for gene therapy products. This draft…
Manufacturing of cellular and gene therapy products during Covid-19 pandemic.
Today, from Revio, we would like to share with you a review of the Industry Guidance on manufacturing of cellular and gene therapy products (CGT) authorised by the Food and…
Summary of the Reflection paper on clinical aspects related to tissue engineered products
Today, from Revio, we would like to share with you a summary of the Reflection paper on clinical aspects related to tissue engineered products (EMA/CAT/573420/2009) adopted 19 September 2014.Tissue engineered…
First revision of EMA guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
In November 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a revision on the EMA’s Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically…
Skysona: the first gene therapy to treat children with rare neurological disease.
European Medicines Agency (EMA) has recommended granting a marketing authorisation in the EU for the gene therapy Skysona (elivaldogene autotemcel). Skysona is currently pending for European Commission decision.Skysona is indicated…