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 advanced therapy medicinal product (ATMPs) containing genetically modified cells. You can look it up here.
If you want to provide comments, you should send them to EMA before 31 October 2021.
The purpose of this draft guideline is to provide applicants and regulators with harmonised guidance on the information to be included in the Product Information (PI) of ATMPs in order to address previously identified inconsistencies in the PI annexes of these complex products.
This guideline complements the information on ATMPs already provided in the QRD template and SmPC guideline. It adds specific focus on 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 CD34+ modified cells are given in more detail.
This guideline includes new statements to be used, whenever they are applicable, for ATMPs containing genetically modified cells. These new statements have been included in the following sections of the annexes I and III of the Product Information:
ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS
Name of the medicinal product
“The strength should be expressed on the basis of the general term ‘cells’, which in this section is considered to define cells which contribute to the therapeutic effect.”
Quality and quantitative composition
“A detailed description of the cells or tissues contained in the product and their specific origin shall be provided, including the species of animal in cases of non-human origin.”
Clinical particulars, specifically the following sections:
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.8 Undesirable effects
“Immunogenicity must be addressed in the subsection “Description of selected adverse reactions”. Data from clinical studies should be summarised in this subsection.”
ANNEX III. LABELLING AND PACKAGE LEAFLET
- Particulars to appear on the outer packaging and immediate packaging.
- Minimum particulars to appear on blisters or strips.
- Minimum particulars to appear on small immediate packaging units.
- Particulars to appear on the lot information sheet, release for infusion certificate, included with each shipment for one patient.
Invented name, strength, pharmaceutical form
‘’A description of the type of cell as per section 2 of the SmPC should be included in this section beside the INN in brackets e.g. (CAR+ viable T cells) or (CD34+ cells).’’
‘’If the medicine is an advanced therapy medicine which contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin, should be provided in line with section 2.1 of the SmPC.’’
Warning and precautions
‘’The expiry date may specify the day, or day and time for non-cryopreserved products.’’
Other information about the Draft Guideline on core SmPC, Labelling and Package Leaflet for ATMPs containing genetically modified cells
Full statement of the active substance and excipients, precautions to be taken before handling or administering the medicinal product, preparation prior to administration.
‘’If applicable, the thawing process must be detailed in full in the following section: Thawing.’’
This is some of the information you need to know if you are interested in the new draft guideline on SmPC, Labelling and Package Leaflet for ATMPs. If you want to know more, you can check out the official guideline here.
We hope you find this useful and of interest. If you would like to discuss any of these updates with the team at REVIO, please get in touch here.