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 the Agency’s work by responding to public consultations. Learn more about how the pharmaceutical industry is actively involved in the work of the Agency.
Featured information
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Applying for a medicine to be used both in and outside the EU
EMA is inviting comments on its draft guidance on applying in parallel for an EU marketing authorisation and an opinion under its ‘EU-M4all’ procedure for a medicine to be used outside the EU. The deadline to comment is 15 February 2021.
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EMA celebrates 15 years supporting SMEs in the EU
EMA’s recent roundtable with SME stakeholders and latest SME survey results highlight the key achievements of the SME Regulation and the challenges and opportunities for EU support to SMEs in the pharmaceutical sector.
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Paediatric medicines: progress on action plan
A progress update is available on the EMA / European Commission action plan for supporting the development of medicines for children. It specifies the status of each action and outlines concrete achievements to December 2020.
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European medicines agencies network strategy to 2025
The strategy sets out how the network will continue to enable the supply of safe and effective medicines, in the face of developments in science, medicine, digital technologies, globalisation and emerging health threats, such as the COVID-19 pandemic.
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Coronavirus disease (COVID-19)
Keep up to date with the latest information on how EMA is handling the COVID-19 pandemic.
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New online platform for scientific advice
From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice. Guidance is available on how to register for IRIS and use it for scientific advice and other procedures..
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News for pharmaceutical industry
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List item25/01/2021
Cyberattack on EMA - update 6
Further to the cyberattack on EMA last year, some of the unlawfully accessed documents including email correspondence have been made public through the Internet and were subsequently picked up by some media outlets. This was the subject of a public...
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List item22/01/2021
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021
CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025 CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a type II variation application for Exzolt (fluralaner ) to...
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List item21/01/2021
Veterinary medicines: highlights of 2020
EMA has published an overview of its key recommendations of 2020 regarding the authorisation and safety monitoring of veterinary medicines. In 2020, EMA recommended 20 medicines for marketing authorisation, including 13 with a new active substance...
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List item21/01/2021
Human medicines: highlights of 2020
EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended 97 medicines for marketing authorisation. Of these, 39 had a new active substance which...
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List item19/01/2021 COVID-19
Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe,...
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List item15/01/2021
Cyberattack on EMA - update 5
The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines have been leaked on the internet. This included internal/confidential email correspondence dating...
Events of interest
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List itemMon-Thu 13-16 Dec13/12/2021 - 16/12/2021
Committee for Medicinal Products for Human Use (CHMP): 13-16 December 2021
The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for...
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List itemTue-Thu 07-09 Dec07/12/2021 - 09/12/2021
Committee for Medicinal Products for Veterinary Use (CVMP): 07-09 December 2021
The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible...
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List itemMon-Thu 29-02 Nov-Dec29/11/2021 - 02/12/2021
Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for...
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List itemMon-Wed 22-24 Nov22/11/2021 - 24/11/2021
Committee for Herbal Medicinal Products (HMPC): 22-24 November 2021
The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for...
Key content
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Research and development
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Innovation in medicines
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Pharmacovigilance
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Data on medicines (ISO IDMP standards)
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United Kingdom’s withdrawal from the European Union ('Brexit')
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Supporting SMEs
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PRIME: priority medicines
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Antimicrobial resistance