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
SME office annual report for 2023
The 2023 annual report of EMA's office for small and medium-sized enterprises (SMEs) is available. Findings include an increase in the number of SME briefing meetings and a rise in the success rate of marketing authorisation applications for human medicines.
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Agencies (HMA) are inviting marketing authorisation holders, applicants and sponsors to comment on their revised draft guidance on protecting personal data and commercially confidential information from marketing authorisation applications for human medicines.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.
Appointment of (co-)rapporteurs for human medicine evaluations
From 1 February 2024, marketing authorisation applicants for human medicines need to complete an additional form during the pre-submission stage, and submit this as an annex to their letter of intent, to enable EMA to appoint (co-)rapporteurs. The form is available via EMA's Service Desk. For more information, see EMA’s pre-authorisation guidance, under ‘Steps prior to submitting the application’ (question 2.4).
Revised guideline on acceptability of names for human medicines
A revised guideline governing the naming of centrally authorised human medicines applies from 1 January 2024. It uses new concepts such as cognitive error, umbrella branding and ‘in use’ status, and clarifies certain criteria for addressing concerns about safety or public health and objections about similarity with international non-proprietary names (INNs). All concerned pharmaceutical companies, trade associations and consulting firms should refer to the revised guideline.
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
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
NewsHumanCOVID-19Medicines
The European Medicines Agency's (EMA) office is closed from 18:00 on Wednesday 8 May 2024 to 07:30 on Monday 13 May 2024. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.
NewsCorporate
Today, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda...
NewsHumanVeterinaryCorporate
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting.
NewsVeterinaryMedicines
Publications of interest
EMA's 2022 annual report
Navigate through the digital report to view interviews, short videos and an interactive timeline of the Agency’s main activities in 2022. 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).