The European Medicines Agency (EMA) has issued a draft guideline for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPS containing genetically modified cells.
What is the legal basis of the guideline?
This guideline should be read in conjunction with Article 11 and Annex V of Directive 2001/83/EC as amended, and Annexes II, III and IV of Regulation 1394/2007 on ATMPs. The guideline on SmPC and QRD product information templates and other reference documents should be read in the context of this guideline.
What is the aim of the draft guideline?
The draft guideline describes the information to be included in the Summary of Products Characteristics (SmPC), referred to as the core SmPC, Labelling and Package Leaflet for Advanced Therapy Medicinal Products (ATMPs) containing genetically modified cells.
The layout of the main section (section 5) of the guideline is the same as the QRD product information template.
What is the scope of the guideline?
The core SmPC only covers medicinal products containing genetically modified cells, allogeneic or autologous, including viral vector modified and genome edited cells.
Examples for Chimeric Antigen Receptor T (CAR-T) cells and Cluster of Differentiation 34+ (CD34+) modified cells are given in more detail. These can be used as model wording for other types of genetically modified cells.
What is the deadline for comments?
The deadline for comments is 31 October 2021. The completed comments form (obtained via a link on the cover page the guideline) should be sent to QRD@ema.europa.eu
Source: European Medicines Agency