Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products


The EMA has published a draft revision to its 2006 guideline on product development quality considerations for inhaled and nasal products. The revised document contains significant changes that reflect both scientific progress in the field and the experience gained from product applications and scientific advice sessions. It is intended to be used in conjunction with a separate draft guideline, published simultaneously, on demonstrating the equivalence of orally inhaled products.

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