Framework for interaction with pharmaceutical industry stakeholders

The framework for interaction with industry stakeholders formalises and structures interactions with pharmaceutical industry associations active in the human and veterinary medicines.

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.

For more information, see: 

• Partners & networks: Pharmaceutical industry

Framework for interaction

The framework for interaction with industry stakeholders formalises and structures interactions with pharmaceutical industry associations active in the human and veterinary medicines. It defines the following objectives:

• provide a platform to exchange views and promote dialogue with stakeholders on topics concerning medicines for human and veterinary use;
• improve communication and provide efficient, targeted and timely information in a proactive manner;
• enhance stakeholders' understanding of the EU medicines regulatory framework and the role of the regulators and enrich the EMA's understanding of issues that are pertinent from the industry perspective for product development and licensing;
• build on existing interactions between industry (including SMEs), academia and other stakeholders in the overall science, medicines, and healthcare arenas by co-operating with established networks and alliances;
• increase transparency of stakeholders engaging with the EMA and report on the interaction.

EMA's Management Board endorsed the framework for interaction in October 2015:​

• Framework for interaction between EMA and industry stakeholders

EMA will undertake regular surveys to monitor the implementation of this framework and will publish a report on the progress of interacting with industry stakeholders annually.

The framework is in line with EMA's overarching framework for stakeholder relations management, which the EMA Management Board adopted in June 2016:

European Medicines Agency (EMA) stakeholder relations management framework

Reference Number: EMA/48651/2016

Reports

EMA published a biennial report on its interaction with industry stakeholders.

EMA’s biennial report on stakeholder engagement activities 2024-2025

Previous reports

Stakeholder engagement report 2022-2023

European Medicines Agency’s interaction with industry stakeholders - Biennial report 2020-2021

European Medicines Agency’s interaction with industry stakeholders - Biennial report 2018-19

Reference Number: EMA/17744/2021 Summary:

European Medicines Agency’s interaction with industry stakeholders - Biannual report 2018-19

European Medicines Agency’s interaction with industry stakeholders - Annual report 2017

European Medicines Agency’s interaction with industry stakeholders - Annual report 2016

European Medicines Agency’s interaction with industry stakeholders - Annual report 2015

Reference Number: EMA/48651/2016

Report - Industry stakeholders and EU network experts surveys on early engagement fostering innovation

Reference Number: EMA/50604/2025

Surveys

EMA routinely gathers feedback on its interactions with EU industry stakeholders. Click on the expandable sections below to find out more about each survey. 

Engagement and communication activities

EMA conducted a survey on its communication and engagement activities with industry stakeholders. 

The survey, carried out with the support of eligible industry stakeholder organisations representing key human and veterinary medicines sectors, aimed to assess the implementation of the framework for interaction with industry stakeholders and gather feedback on the effectiveness of the Agency's communication and engagement activities. 

The results are available in the report below.

Report - Industry stakeholders' feedback on engagement and communication activities

Reference Number: EMA/273178/2025

Innovation and competitiveness

Innovation and competitiveness are part of the key strategic goals of the European Medicines Agencies Network Strategy (EMANS).

In line with those goals EMA has conducted two surveys on early engagement fostering innovation. One targeting stakeholders and the other targeting the network.

The results are available in this report:

Report - Industry stakeholders and EU network experts surveys on early engagement fostering innovation

Reference Number: EMA/50604/2025

Centralised post-authorisation Type IB and Type II variations and PSUR procedures

Between 2015 and 2017, these surveys summarised outcomes related to topics such as centralised post-authorisation Type IB and Type II variations and PSUR procedures.

Outcome of the European Medicines Agency survey on centralised post-authorisation procedures 2015

Reference Number: EMA/156890/2016 Summary:

Outcome of the European Medicines Agency (EMA) survey on centralised post-authorisation procedures 2015

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2016.

See update history

4 September 2026

Content reorgansied with some content moved to another page as part of a broader content reorganisation

31 March 2026
'EMA Industry Highlights Newsletter' section added to the page