EMEA publishes Concept Paper on the Revision of the Guidance on Radiopharmaceuticals based Monoclonal Antibodies

Not long ago, the EMEA announced in a concept paper that it plans to update the Note for Guidance on Radiopharmaceuticals Based Monoclonal Antibodies (Eudralex 3AQ21a) of 1991 to the state of the art. With this step, the Agency intends to draw level with two other EMEA guidelines on radiopharmaceuticals (CHMP/QWP/306970/2007 Rev 1) and specifications on monoclonal antibodies (CHMP/BWP/157653/2007) which were upgraded recently. The revision will include quality aspects on radiopharmaceutical aspects as well as on monoclonal antibodies in order to achieve harmonisation with the two above-mentioned guidelines. For this reason, it would be an advantage if the same working group members who revised the above guidelines could also take care of this revision. According to the concept paper's schedule, the draft for the revised guideline should be ready for commenting by the industry in the 3rd quarter of 2010. The publication of the final version is then targeted for the 2nd quarter of 2011. With the revision, the EMEA hopes to reach a harmonised approach in the EU to the development and assessment of radioactive monoclonal antibodies.

The concept paper can be found here.
Sven Pommeranz
On behalf of the European Compliance Academy (ECA )

PS. If you are especially interested in radiopharmaceuticals: In our GMP News of 15 October 2008, we reported about the revision of Annex 3 to the EC GMP Guide, which deals with the manufacture of radiopharmaceuticals.

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