After the finalisation in 2008 of the revision of the guideline on Radiopharmaceuticals and the revision of the guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related products, the 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 concept paper determines the following timetable

• Appointment of Rapporteur for the revision of the guideline in June 2009
• Re-instalment in 3Q 2009 of the drafting group on Radiopharmaceuticals, with the involvement of additional experts on monoclonal antibodies
• Publication of the concept paper in September 2009
• Release of the revised guideline for consultation in 3Q 2010
• Publication of the finalised revised guideline in 2Q 2011.

Interested parties

The main industry interested parties are: EANM (European Association of Nuclear Medicine), AIPES (Association of Imaging Producers and Equipment Suppliers) and EFPIA (European Federation of Pharmaceutical Industries and Associations). BWP (Biologics Working Party) is the main regulatory interested party.

Comments on the concept paper should be sent to qwp@emea.europa.eu by 31 January 2010. The comments received will be considered for the revision of the guideline.

OUTCOMES

Check your procedures if they are compliant with following guidelines which have been finalized in 2008.

• Guideline on Radiopharmaceuticals (CHMP/QWP/306970/2007 Rev. 1, formerly 3AQ20a)
• Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related products (CHMP/BWP/157653/2007, formerly 3AB4a)

Link to the Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies

Source: EMEA Inspections website