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The regulatory framework for medicines has continuously evolved over time. This has enabled faster access to new medicines, both those for unmet medical conditions and high quality affordable generic and biosimilar alternatives.

The procedures have also adapted to help meet the needs of more categories of patients, in particular children and those with rare diseases. This has led to a highly developed mature Europe wide system which is broadly effective in delivering its’ twin roles of protecting public health at the same time as making safe and effective medicines quickly available to the patients of Europe. These are shared objectives of patients, carers, health insurers, governments, regulatory agencies and the pharmaceutical industry. Looking forward, there are opportunities for taking an ambitious approach to identify future improvements to benefit all stakeholders.

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