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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
Benefits continue to outweigh risks, but important restrictions on the medicines' use are recommended
Studies required to further characterise efficacy

12 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting

Emer Cooke spoke about reimagining the future of medicines regulation as part of the Sir Alasdair Breckenridge Lecture Series