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Regulatory update

Mid-year report and new pharmaceutical legislation among key topics

International harmonisation is a key pillar of EMA’s 3Rs strategy

Emer Cooke spoke about EMA’s role in helping improve health outcomes for women

10 priorities proposed to drive change in medicines for women’s health

12 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Studies required to further characterise efficacy
Benefits continue to outweigh risks, but important restrictions on the medicines' use are recommended
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting

PRAC starts safety review of injectable iron-containing medicines