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Learn more about how how the pharmceutical industry is actively involved in EMA's work.
Featured information for the pharmaceutical industry
Submission predictability report
A report is available including recommendations to improve the precision, preparedness and communication of marketing authorisation application submissions. The report is based on a 2023 EMA exercise in monitoring submissions delays. EMA's focus group on submission predictability published the report in July 2024. Representatives of pharmaceutical industry, EMA committees and national competent authorities take part in this group.
New updates to the parallel scientific advice with the United States for veterinary medicines
EMA and the United States’ Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) updated the parallel scientific advice programme for veterinary medicines. Updates include more defined timelines and an additional meeting between medicine developer and both authorities. For more than 15 years, this programme has allowed medicine developers to exchange views on scientific issues with both authorities simultaneously. Integrated advice from both authorities can optimise product development and streamline testing.
Stakeholder consultation on proposal to revise European Commission variations guidelines
EMA, the Heads of Medicines Agencies and the European Commission are inviting interested parties to comment on the revised draft guidelines on variations categories and procedures. This proposal aims to make the lifecycle management of human medicines more efficient and future-proof. Provide your comments by 23 August 2024. The proposed changes and dedicated EU survey are available via the link in the title.
Paediatric applications moved to IRIS platform
From 4 June 2024, the IRIS platform will provide a secure online environment for applicants to submit and manage their paediatric medicines applications and related documents. The previous submission process only applies for ongoing applications submitted before 4 June. With IRIS, applicants can check the status of their applications and get automatic updates from any device. IRIS simplifies interaction with EMA, improves data quality, transparency and efficiency in the paediatric application process.
EMA's SME office launches survey to gather feedback
EMA invites small and medium-sized enterprises (SMEs) and industry stakeholders to complete an online survey on the EMA's support, incentives, and services for SMEs. The feedback gathered will help EMA to understand current issues and better tailor future activities to their needs. The survey is open until 16 September.
Promoting a One Health approach in Europe
EMA and other scientific EU agencies responsible for human, animal health and environmental protection have issued a joint statement on promoting a joined-up One Health agenda in Europe. They identify four priority areas for action.
Guidance on quality and manufacturing aspects of PRIME and Breakthrough schemes
A joint question-and-answer (Q&A) guidance document is available from EMA and the United States Food and Drug Administration (FDA) for medicine developers on how to address quality development and good manufacturing practice (GMP) challenges when developing medicines under early access schemes, such as EMA's PRIME or FDA's Breakthrough Therapies.
Publications of interest
EMA's 2023 annual report
Navigate through the digital report to view interviews, short videos and an interactive timeline of the Agency’s main activities in 2023. Read the traditional PDF version to see additional figures and statistics on EMA's regulatory procedures and activities.
Factsheet: PRIME – Paving the way for promising medicines for patients
Check our factsheet for an at-a-glance overview of EMA's PRIME scheme.
Video: Working for every patient in Europe
Watch our short video for a quick and easy explanation of who EMA is and what it does. (video in English, with subtitles in 24 different languages).