14/15 December 2023
In July, the EMA announced the 2nd revision of its guidance document on "Quality of Monoclonal Antibodies and Related Products".
This 2016 guideline is also being revised due to the revision of the related guideline "Radiopharmaceuticals based on monoclonal antibodies" (3AQ21A), because when it became effective, it replaced both the guideline on "Production and quality control of monoclonal antibodies" (3AB4A) and the quality requirements for monoclonal antibodies previously listed in the guideline "Radiopharmaceuticals based on monoclonal antibodies" (3AQ21A).
However, the current guideline for monoclonal antibody-based radiopharmaceuticals (Eudralex 3AQ21A) was last revised in 1991, necessitating a thorough revision because it no longer reflects the current state of science and technology. Accordingly, the EMA defined the problem as follows:
"Since 1991, numerous developments have been made in the field of radiopharmaceuticals, i.a. various new antibody formats, new conjugation technologies. At the same time, new manufacturing technologies and analytical methods have evolved concomitant with new regulatory expectations, which are partially reflected in current regulatory documents. These developments need to be addressed in a revised guideline. The revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies will be prepared in parallel with the revision of the quality Guideline on radiopharmaceuticals (EMEA/CHMP/QWP/306970/2007) and with the development of a clinical Guideline for the development of therapeutic radiopharmaceuticals. This specific document will not address the same areas, but complement the links between quality, non-clinical and clinical modules to be included in the dossier."
The revision is intended to reflect current developments in both radiopharmaceuticals and monoclonal antibodies. It is intended to provide recommendations on quality and non-clinical aspects of these products. It will also touch on broader issues or need to address subsequent issues that have come up from the work to date and feedback in the relevant drafting group:
Public comment of the Concept Paper was open until October 31, 2023. More detailed information can be found on the EMA website at.
"Development, production, characterisation and specifications for monoclonal antibodies and related products".