Transparency in drug regulation

News 05/08/2016

Publication of assessment reports in Europe and Australia makes information on medicines more easily available

In a joint article published by Drug Discovery Today, the European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) in Australia describe their positive experiences with the publication of assessment reports for medicines – known as European public assessment reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia. According to the authors, increasing web traffic highlights the regulators' success in facilitating access to medicines' information and the rationale for medicines' approval.

By focusing on validated, evidence-based, and up-to-date information, EPARs and AusPARs contribute to the dissemination of reliable facts on medicines and how they are evaluated and ensure transparency. The reports build on close and consistent interaction with a wide range of stakeholders in order to reflect the perspectives of different audiences.

Scientific progress and stakeholders' desire for greater information entail a continuous evolution in the communication of information on medicines. Both regulators extensively collect feedback on the value of the published information to assess continuously how to best communicate high-quality information on medicines to users and researchers.

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