The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal medicinal drugs, while the other addresses therapeutic equivalence between orally inhaled products.
The quality document was drafted to replace a 2006 guideline. EMA said its aim is to consolidate the 2006 guideline with related published questions and answers while “taking into consideration recent advancements in the field, common practice and new regulations, including the medical device regulation.”…