Drug Regulators, EMEA, Publish Concept Paper on Revision of Guidelines on Radiopharmaceuticals Based on Monoclonal Antibodies
full text here
After the finalisation in 2008 of the revision of the guideline on Radiopharmaceuticals (CHMP/QWP/306970/2007 Rev. 1, formerly 3AQ20a) and the revision of the guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related products (CHMP/BWP/157653/2007, formerly 3AB4a), the CHMP Quality Working Party (QWP) and Biologics Working Party (BWP) agreed that a thorough revision of the guideline on Radiopharmaceuticals Based on Monoclonal Antibodies was needed to take account of scientific developments in the field.
The revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies will focus on quality aspects encompassing both monoclonal antibodies and radiopharmaceutical aspects and will be done so as to ensure consistency and complementarity with the above-mentioned revised guidelines on monoclonal antibodies and on radiopharmaceuticals.
For what concerns the practical arrangements for the development of the revised guideline, it is recommended that the same rapporteur and the same QWP drafting group who worked on the revision of the radiopharmaceuticals guideline also leads the revision of this guideline, with the participation in the drafting group of additional experts on monoclonal antibodies appointed by the CHMP Biologics Working Party (BWP). The BWP drafting group on monoclonal antibodies will be closely involved in the revision of this guideline.
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