A final guideline on the use of phthalates as excipients was issued by EMA in mid-November. The guideline discusses the adverse effects of phthalates on reproduction and development and proposes different daily exposure values for the various types of phthalates. EMA explains that the guideline’s recommendations are meant to be precautionary “in the absence of clinical evidence on phthalate-induced adverse effects in humans.” New applications are expected to comply with the guideline when it comes into effect in June 2015, while existing products have three years to implement changes.
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