EMA SAYS RULES ON PHTHALATES IN MEDICINES WILL NOT BLOCK ESSENTIAL TREATMENTS
January 1st, 2017
German pharma major Boehringer Ingelheim has called for and received reassurance from the European Medicines Agency (EMA) that planned controls on the use of certain phthalates in pharmaceuticals will not lead to swift bans of products. It was commenting on draft EMA guidance on the use of phthalates as excipients in human medicines. Boehringer asked where phthalates exceed EMA’s planned limits and reformulations are not possible, would EMA insist on voluntary withdrawals of products, a phase-out of supplies, and could label updates alone be required? In reply ...
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