EMA finalises opinion on presence of nitrosamines in medicines

EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as much as possible and to ensure levels of these impurities do not exceed set limits. The measures will ensure that nitrosamines are either not present or are present below levels identified […]

Restriction and authorisation found to drive replacement of harmful chemicals

Replacing harmful chemicals with safer alternatives and greener technologies is strongly driven by regulation, with companies reporting that restrictions and authorisation are their main drivers for substitution. Companies are also motivated by customer demand and their own sustainability policies, with ECHA’s substitution strategy also indirectly boosting substitution activities. While restrictions and authorisation directly encourage European […]

Launch of public consultation on joint network strategy to 2025

EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face […]