Trade group defends its transparency regarding meetings with EMA

Yesterday’s announcement that the European Ombudsman Emily O’Reilly is  instigating an inquiry into the European Medicines Agency’s pre-submission meetings with pharmaceutical companies regarding  marketing authorization applications (MAAs) has prompted a response from trade group the European Federation of Pharmaceutical Industries and Associations (EFPIA).

It stresses that European citizens rely on medicines developers to successfully and rapidly bring forward new medicines to meet the unmet needs of patients. The EFPIA considers pre-submission and pre-authorization 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.