Early Access to Pharmaceutical Products in Major European Markets

The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.

In order to understand the EMA's approach to early access schemes in even more depth, Hogan Lovells has created a guide that provides a comparison of EMA and U.S. early access rules. The guide includes recommendations for establishing and implementing early access programs, tracking use and drug supply, and identifies the potential negative impact of these programs with a high level overview of early access programs for Germany, Italy, France, Spain, the Netherlands and UK, as well as for Russia and South Africa.

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