EMA briefs

Published: 23-Dec-2009


The European Medicines Agency (EMA) has released a guideline on validation of bioanalytical methods in pharmaceutical production - see

Bioanalytical methods guideline

EMA and the EU's Heads of Medicines Agencies (HMA) organisation have released recommendations on handling requests for access to periodic safety update reports - see Periodic safety update reports


Meanwhile, EMA has released submission deadlines for advanced therapy medicinal products - see Deadlines for advanced therapy medicinal products and Deadlines for advanced therapy medicinal products

The agency has released a guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - see

Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis;

EMA has released a table of translations required for orphan drug designation applications - see

Table of translations required for orphan drug designation applications

And it has published a draft standard paediatric investigation plan for allergen products for specific immunotherapy - see

Draft standard

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