EMA event supporting materials

Brochure on EMA's role in medicines regulation across the EU
Timeline and brochure on the journey of a medicine from lab to patient
Annual report on EMA's activities in 2021
Brochures on medicines authorised via EMA in 2022
How EMA contributes to tackling COVID-19
EMA's responsibilities in overseeing clinical trials
EMA's strengthened role in the veterinary field
How EMA supports SMEs
Guides for companies developing advanced therapies
Report on EMA's work in the international arena

EMA has selected this series of key materials for attendees of DIA so that you have quick access to information about how EMA works and its recent initiatives.

Brochure on EMA's role in medicines regulation across the EU

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The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union (PDF/4.97 MB)

First published: 26/08/2014
Last updated: 19/12/2017
- Bulgarian
  (PDF/5.37 MB)
- Croatian
  (PDF/5.37 MB)
- Czech
  (PDF/5.37 MB)
- Danish
  (PDF/5.38 MB)
- Dutch
  (PDF/5.38 MB)
- Estonian
  (PDF/5.33 MB)
- Finnish
  (PDF/5.35 MB)
- French
  (PDF/5.39 MB)
- German
  (PDF/5.38 MB)
- Greek
  (PDF/5.37 MB)
- Hungarian
  (PDF/5.4 MB)
- Icelandic
  (PDF/5.37 MB)
- Italian
  (PDF/5.38 MB)
- Latvian
  (PDF/5.37 MB)
- Lithuanian
  (PDF/5.38 MB)
- Maltese
  (PDF/5.38 MB)
- Norwegian
  (PDF/5.38 MB)
- Polish
  (PDF/5.37 MB)
- Portuguese
  (PDF/5.39 MB)
- Romanian
  (PDF/5.39 MB)
- Slovak
  (PDF/5.37 MB)
- Slovenian
  (PDF/5.38 MB)
- Spanish
  (PDF/5.38 MB)
- Swedish
  (PDF/5.38 MB)

Timeline and brochure on the journey of a medicine from lab to patient

From laboratory to patient brochure - the journey of a medicine assessed by EMA

Check our interactive timeline to learn about each stage a medicine goes through from initial research to patient access, and about how EMA supports medicine development, assesses the benefits and risks of medicines and monitors their safety.

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From laboratory to patient: the journey of a centrally authorised medicine (PDF/1.75 MB)

First published: 04/03/2019
Last updated: 10/02/2020
- Bulgarian
  (PDF/4.71 MB)
- Croatian
  (PDF/4.76 MB)
- Czech
  (PDF/4.72 MB)
- Danish
  (PDF/4.62 MB)
- Dutch
  (PDF/4.63 MB)
- Estonian
  (PDF/4.73 MB)
- Finnish
  (PDF/4.71 MB)
- French
  (PDF/4.84 MB)
- German
  (PDF/4.89 MB)
- Greek
  (PDF/4.72 MB)
- Hungarian
  (PDF/4.65 MB)
- Italian
  (PDF/4.7 MB)
- Latvian
  (PDF/4.74 MB)
- Lithuanian
  (PDF/4.63 MB)
- Polish
  (PDF/4.86 MB)
- Portuguese
  (PDF/4.63 MB)
- Romanian
  (PDF/4.85 MB)
- Slovak
  (PDF/4.77 MB)
- Slovenian
  (PDF/4.78 MB)
- Spanish
  (PDF/4.84 MB)
- Swedish
  (PDF/4.61 MB)

Annual report on EMA's activities in 2021

EMA annual report 2021 Explore our Digital annual report 2021 to learn about EMA's activities during 2021.

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2021 annual report of the European Medicines Agency (PDF/10.95 MB)

Adopted

First published: 10/06/2022

Brochures on medicines authorised via EMA in 2022

To find out more, see:

Medicine evaluation figures

How EMA contributes to tackling COVID-19

One year since the first COVID-19 vaccine approval in EU - illustration

Learn about EMA's contribution to tackling the COVID-19 pandemic, by facilitating rapid access to .

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One year since the first COVID-19 vaccine approval in the EU (PDF/391.56 KB)

First published: 22/12/2021

EMA's responsibilities in overseeing clinical trials

Clinical trials information system - key for sponsors (CTIS) brochure

Learn about the Clinical Trials Regulation, including how it overhauled the oversight of clinical trials in the EU, and EMA's new responsibilities in this area.

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Clinical trials information system - Key information for sponsors on CTIS (PDF/512.67 KB)

First published: 31/01/2022
Last updated: 17/05/2022

Accelerating Clinical Trials in the EU (ACT EU)

EMA's strengthened role in the veterinary field

Information on new Veterinary Regulation - illustration

Read our news announcement on the entry into application of the Veterinary Medicinal Products Regulation to find out how the Regulation changed the rules on the authorisation and use of veterinary medicines in the EU, and to learn about EMA's strengthened role in the veterinary field.

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Infographic - Categorisation of antibiotics for use in animals for prudent and responsible use (PDF/1.05 MB)

First published: 28/01/2020
Last updated: 09/06/2020
- Bulgarian
  (PDF/149.91 KB)
- Croatian
  (PDF/140.48 KB)
- Czech
  (PDF/161.55 KB)
- Danish
  (PDF/151.02 KB)
- Dutch
  (PDF/138.45 KB)
- Estonian
  (PDF/146.51 KB)
- Finnish
  (PDF/138.01 KB)
- French
  (PDF/154.75 KB)
- German
  (PDF/151.68 KB)
- Greek
  (PDF/170.49 KB)
- Hungarian
  (PDF/157.67 KB)
- Italian
  (PDF/139.24 KB)
- Latvian
  (PDF/166.81 KB)
- Lithuanian
  (PDF/160.33 KB)
- Maltese
  (PDF/145.69 KB)
- Polish
  (PDF/144.44 KB)
- Portuguese
  (PDF/138.83 KB)
- Romanian
  (PDF/141.92 KB)
- Slovak
  (PDF/153.17 KB)
- Slovenian
  (PDF/141.04 KB)
- Spanish
  (PDF/138.47 KB)
- Swedish
  (PDF/136.65 KB)
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Antimicrobial resistance - Infocards (PDF/6.46 MB)

First published: 18/11/2022

To find out more, see:

Veterinary Medicinal Products Regulation

How EMA supports SMEs

To find out more, see

Supporting SMEs

Guides for companies developing advanced therapies

To find out more, see:

Advanced therapy medicinal products: Overview

Report on EMA's work in the international arena

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Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives (PDF/6.03 MB)

First published: 13/10/2016
Last updated: 09/01/2017

To find out more, see:

International activities

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EMA event supporting materials

Table of contents

Brochure on EMA's role in medicines regulation across the EU

The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union (PDF/4.97 MB)

Timeline and brochure on the journey of a medicine from lab to patient

From laboratory to patient: the journey of a centrally authorised medicine (PDF/1.75 MB)

Annual report on EMA's activities in 2021

2021 annual report of the European Medicines Agency (PDF/10.95 MB)

Brochures on medicines authorised via EMA in 2022

Human medicines highlights 2022 (PDF/1.95 MB) (updated)

Veterinary Medicines Highlights 2022 (PDF/894.72 KB)

How EMA contributes to tackling COVID-19

One year since the first COVID-19 vaccine approval in the EU (PDF/391.56 KB)

EMA's responsibilities in overseeing clinical trials

Clinical trials information system - Key information for sponsors on CTIS (PDF/512.67 KB)

ACT EU multi-annual workplan 2022-2026 (PDF/207.06 KB)

Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials - Accelerating Clinical Trials in the European Union (ACT EU) (PDF/341.82 KB)

EMA's strengthened role in the veterinary field

Infographic - Categorisation of antibiotics for use in animals for prudent and responsible use (PDF/1.05 MB)

Antimicrobial resistance - Infocards (PDF/6.46 MB)

How EMA supports SMEs

Small and medium-sized enterprise (SME) Office annual report 2021 (PDF/302.98 KB)

User guide for micro, small and medium-sized enterprises (PDF/1022.94 KB)

Guides for companies developing advanced therapies

Guide on advanced therapy medicinal products - Quality flowchart (PDF/144.33 KB)

Guide on advanced therapy medicinal products - Non-clinical development flowchart (PDF/145.37 KB)

Guide on advanced therapy medicinal products - Clinical development flowchart (PDF/147.32 KB)

Report on EMA's work in the international arena

Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives (PDF/6.03 MB)

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