Pharmaceutical industry
On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events.
You can contribute to EMA's work by responding to our public consultations.
Learn more about how how the pharmceutical industry is actively involved in EMA's work.
Featured information for the pharmaceutical industry
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 12 July.
Have your say and help shape EMA’s future communications
Help EMA meet your communication needs by completing EMA's latest communication perception survey. Provide your feedback by 21 June 2024.
Public consultation for revised EMA-HMA guidance on commercially confidential information and personal data
EMA and the Heads of Medicines Agencies (HMA) are inviting marketing authorisation holders, applicants and sponsors to comment on their revised draft guidance on protecting personal data and commercially confidential information from marketing authorisation applications for human medicines. The proposed revision includes updates to the scope and methodology for protecting this type of data, reflecting current EU and national laws. The deadline for comments is 28 June 2024.
Update of the human marketing authorisation transfer procedure
Marketing authorisation holders (MAHs) of human medicines will benefit from a simplified transfer procedure that will streamline the application process. This will include new templates and require fewer attachments, reducing administrative burdens and increasing efficiency. Updated questions and answers are available on the EMA corporate website. MAHs can still use previous templates until 30 June 2024.
Update of the veterinary marketing authorisation transfer procedure
Marketing authorisation holders of veterinary medicines will benefit from a simplified transfer procedure, with new templates to facilitate application and fewer required attachments. They will also be able to change the qualified person responsible for pharmacovigilance. EMA updated the related questions and answers to enhance efficiency, clarity and compliance throughout the marketing authorisation transfer process. A transitional period allows marketing authorisation holders to continue using previous templates until 30 June 2024.
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.
Latest news
Start of review of painkiller metamizole and risk of secondary cancers with CAR T-cell medicines.
NewsHumanMedicinesPharmacovigilanceReferrals
Board adopts Executive Director’s annual activity report for 2023 and hears updates on implementation of new fee regulation.
NewsHumanCorporateClinical trialsFeesMedicine shortages
Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU.
NewsHumanClinical trials
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.
NewsHumanMedicinesVaccines
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).