Draft Guideline on Labeling Immunoglobulin Products Released by EMA
The European Medicines Agency (EMA) has released a new draft guideline for sponsors of human normal immunoglobulin for subcutaneous and/or intramuscular administration pertaining to the summary of product characteristics (SmPC) required to be submitted to EMA and the European Commission.
The guideline, released 31 July 2012 by EU regulators, notes sponsors of the products will be required to list different SmPCs on the product depending on whether it is intended for subcutaneous administration, intramuscular administration or both.
While several aspects of the harmonized SmPC labeling standard are product-specific-its effect on pediatric populations, excipients used, contraindications, safety issues and preclinical safety data, for example-it presents a largely similar template capable of being used by most immunoglobulin products.
EMA regulators said the guideline will eventually replace an earlier 2002 guideline of a similar name.
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