EMA takes note of the European Ombudsman’s decision on pre-submission activities

News 19/07/2019

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency. Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, safe and effective medicines to patients. At the same time, EMA recognises the importance of guaranteeing the independence of the medicine assessment which takes place at a later stage.

Supporting better designed studies means that patients will not be deprived of a beneficial medicine simply because poorly designed trials failed to demonstrate that the medicine works and is safe. By supporting the conduct of well-designed studies, scientific advice protects patients from taking part in studies that are sub-standard or will not produce useful evidence for a marketing authorisation.

Scientific advice aims to help medicine developers generate robust and complete data on the benefits and risks of a medicine. The sooner it can be shown that a new medicine works and is safe, the sooner it can be made available to patients. This is particularly critical in areas of unmet medical need. But even where there is no unmet need, an improved choice of treatments is a benefit for patients, allowing more tailored therapy and helping to support long-term sustainability of healthcare systems.

The recommendations of the Ombudsman take into consideration the views and perspectives from a wide range of stakeholders, which provide helpful insights for the Agency. EMA will now look into the recommendations in detail and consider any further action needed. This would complement the measures EMA has already taken since the launch of the inquiry in 2017, which were positively noted by the Ombudsman in her decision.

The exchanges with the Ombudsman on EMA’s pre-submission activities were very constructive and allowed EMA to further clarify how scientific advice is generated, what safeguards are put in place to guarantee independence of the assessment and how the Agency has been improving transparency. They also provided an opportunity for EMA to identify certain measures that could already be initiated to further improve transparency and confidence in the Agency’s pre-submission activities.

To better explain the regulatory activities during development and evaluation, EMA recently published a comprehensive booklet on its pre-submission and assessment processes.

EMA has also started an initiative to provide more information on scientific advice in the public assessment report that underpins the marketing authorisation of a medicine (EPAR). This includes the provision of the topics on which scientific advice was received during development, and a discussion on how this was taken up by the developer.

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