EMEA News in Brief
The EMEA has released a revised priority list for studies into off-patent paediatric medicinal products, for which researchers can receive funding through the European Commission's seventh framework programme.
The EMEA has released a revised priority list for studies into off-patent paediatric medicinal products, for which researchers can receive funding through the European Commission's seventh framework programme.
It has published guidelines for non-clinical and clinical uses of biological medicinal products containing erythropoietins, which are responsible for stimulating red blood cell production; and has also released a guideline for achieving better pharmacovigilance in relation to vaccines against infectious diseases, calling on market authorisation holders to weigh the risks of vaccines against the benefits.
Meanwhile, the European Commission has revised its guideline for submitting summary of product characteristics (SmPC) reports in marketing applications; these will come into effect May 2010.