EFPIA notes the EU Ombudsman’s decision to conduct a strategic inquiry into the arrangements that the European Medicines Agency has in place for engaging with individual medicines developers before the Agency receives applications for marketing authorisation. 

European citizens rely on medicines developers to successfully and rapidly bring forward new medicines to meet the unmet needs of patients. EFPIA considers pre-submission and pre-authorisation guidance, including scientific advice, given by a regulatory authority as an essential part of drug development  to manage the complex regulatory procedures and to ensure the developers are able to deliver effective, safe and high-quality medicines to patients. 

The EMA provides transparent guidance to medicine developers on the Agency’s publicly available website. It includes procedural guidance and advice on what type of interactions medicines developers are allowed to have with the regulator prior to, or during the course of the application process. The guidance addresses any pre-submission questions the applicant may have and lays out rules for interactions between the Agency and the developer.  

Another dedicated EMA website gives guidance on how to seek scientific advice, which is a voluntary and non-binding interaction between the developer and the regulator and can be requested at any stage of the development process. These interactions focus on development strategies rather than pre-evaluation of data to support a marketing-authorisation application. They help to avoid conducting unnecessary animal tests (advice on preclinical phase) or help to refine clinical trial designs in humans to ensure they only deliver evidence required for subsequent regulatory decision-making. 

The science behind medicines development is advancing rapidly, in that context, the transparent framework of early dialogue is increasingly critical. It is not always straight-forward for example on how to incorporate new technologies such as diagnostics, genomics and health app data in to the medicines development process. Collective expertise and dialogue is an essential component in addressing these questions. 

Early, transparent dialogue between regulators and the companies developing new medicines is in the best interest of patients.