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Potential Impact of European Pharma Legislation on Commercialization and Access of New Therapies

An outline of the four key goals of the recently proposed European legislation and the impact they may have on commercialization and access of new therapies.

In April 2023, the European Commission (EC) adopted a proposal for a new directive to revise and replace the existing general pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004).

The proposed reform presents a major overhaul of the existing pharmaceutical regulatory framework, which can be expected to have a substantial impact on the commercialization and the access strategy for the launch of new medical products across the European Union.

Download the white paper below for an overview of the four key goals that the proposed updates plan to address and the potential effect these mandates may have on commercialization, access and promotion of new therapies.

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