The pharmaceutical industry and medical device industry associations in the European Union (EU) are some of the European Medicines Agency's (EMA) main stakeholders. Interacting with pharmaceutical companies has been a major part of EMA's daily business since it began operating. Since 2022, EMA has also interacted with medical device companies, in line with EMA's extended mandate for dealing with public health emergencies. EMA's contacts with these stakeholders are guided by a formal framework that rests on the principles of accountability, transparency and broad representation.

EMA routinely interacts with pharmaceutical and medical device companies through various channels, including:

• overseeing the centralised authorisation procedure, whereby pharmaceutical companies apply for a single marketing authorisation valid throughout the European Union (EU);
• providing scientific advice to companies to support research and development activities;
• offering targeted information to micro, small and medium-sized enterprises (SMEs);
• advising on compliance with EU regulatory requirements; 
• monitoring, preventing and managing shortages of medicines, medical devices and in vitro diagnostics during public health emergencies;
• advising medical device manufacturers on their intended clinical development strategy and proposals for clinical investigation for all high-risk medical devices.

The interactions relating to medical devices are in line with with Regulation (EU) 2022/123.

For certain activities, EMA charges pharmaceutical companies administrative fees. The bulk of the income from fees is redistributed among European Member States who provide the scientific expertise for assessing regulatory applications. For more information, see Fees payable to the EMA.

EMA also regularly discusses topics with industry representatives in the context of public health, including:

• the implementation and operational impact of new legislation and scientific guidelines;
• procedural and/or organisational developments at EMA, including policies such as those on transparency and public access to information;
• the latest scientific advances in medicine and relevant public health emergency topics.