Transparency in drug regulation: public assessment reports in Europe and Australia

- We describe our experiences in publishing European Public Assessment Reports (EPARs) and Australian Public Assessment Reports (AusPARs).
- EPAR and AusPAR publication ensures high transparency about the reasons for marketing authorisation of medicines.
- Web traffic data indicate public assessment reports are being increasingly accessed online.
- Scientific progress and stakeholders' desire for greater information necessitate a continuous evolution in communicating medicines' information.
- Interaction with stakeholders is essential to obtain their perspective and to tailor communication tools appropriately.
- Regulatory agencies can learn from each other when publishing their scientific rationale for medicines approval.

Openness and transparency are important considerations for medicines regulators, where public health is of paramount concern. As part of their commitment to transparency, the European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) in Australia publish information relating to their evaluation of medicines via public assessment reports. European Public Assessment Reports (EPARs) and Australian Public Assessment Reports (AusPARs) provide information about the considerations that led the regulator to approve or refuse the application. The reports summarise assessments by each regulator of the information provided on the quality, safety, and efficacy of the medicine under evaluation. Here, we describe the experiences of two established medicines regulators in publishing public assessment reports, and reflect on their future role in communicating medicines information.