EMEA news in brief

Published: 29-Apr-2008

The European Medicines Agency (EMEA) has published guidance on genotoxicity testing and related data interpretation for pharmaceuticals manufacturing;


The European Medicines Agency (EMEA) has published guidance on genotoxicity testing and related data interpretation for pharmaceuticals manufacturing;

EMEA has released a working group report recommending ways of improving the methodology, consistency, transparency, and communication benefit-risk assessments staged by its committee for human medicinal products;

Procedural advice on appealing against EMEA decisions on orphan medicinal product designations has been published;

EMEA has also released updated rules on paying its fees;

Meanwhile, the European Commission is consulting on an update to its good manufacturing guidelines on basic requirements for active substances used as starting materials; and on the manufacture of investigational medicinal products.

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