Newsletters

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.

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Newsletter archive

Human medicines highlights

Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all the Agency's activities in the area of human medicines.

EMA provides an RSS feed of the human medicines highlights. To subscribe, use the below link and follow our user guide on how to subscribe to RSS feeds:

Human Medicines Highlights newsletter

EMA does not collect any personal data from you when you subscribe to this RSS feed.

Human medicines highlights - April 2024

English (EN) (325.35 KB - PDF)

First published: 11/04/2024

Human medicines highlights - March 2024

Reference Number: Issue 178

English (EN) (352.99 KB - PDF)

First published: 13/03/2024

Human medicines highlights - February 2024

Reference Number: Issue 177

English (EN) (236.57 KB - PDF)

First published: 08/02/2024

Human medicines highlights - January 2024

Reference Number: Issue 176

English (EN) (248.32 KB - PDF)

First published: 11/01/2024

Human medicines highlights - November-December 2023

Reference Number: Issue 175

English (EN) (387.8 KB - PDF)

First published: 14/12/2023

Human medicines highlights - October 2023

Reference Number: Issue 174

English (EN) (329.23 KB - PDF)

First published: 11/10/2023

Human medicines highlights - September 2023

Reference Number: Issue 173

English (EN) (274.2 KB - PDF)

First published: 11/09/2023

Human medicines highlights - August 2023

Reference Number: Issue 172

English (EN) (285.65 KB - PDF)

First published: 14/08/2023

Human medicines highlights - June 2023

Reference Number: Issue 170

English (EN) (305.45 KB - PDF)

First published: 16/06/2023

Human medicines highlights - May 2023

Reference Number: Issue 169

English (EN) (371.05 KB - PDF)

First published: 11/05/2023

Human medicines highlights - April 2023

Reference Number: Issue 168

English (EN) (356.44 KB - PDF)

First published: 12/04/2023

Human medicines highlights - March 2023

Reference Number: Issue 167

English (EN) (340.59 KB - PDF)

First published: 09/03/2023

Human medicines highlights - February 2023

Reference Number: Issue 166

English (EN) (273.8 KB - PDF)

First published: 06/02/2023

Human medicines highlights - January 2023

Reference Number: Issue 165

English (EN) (339.17 KB - PDF)

First published: 11/01/2023Last updated: 18/01/2023

Human medicines highlights - December 2022

Reference Number: Issue 164

English (EN) (342.63 KB - PDF)

First published: 13/12/2022

Human medicines highlights - November 2022

Reference Number: Issue 163

English (EN) (284.79 KB - PDF)

First published: 14/11/2022

Human medicines highlights - September 2022

Reference Number: Issue 162

English (EN) (449.35 KB - PDF)

First published: 12/10/2022

Human medicines highlights - August 2022

Reference Number: Issue 161

English (EN) (347.93 KB - PDF)

First published: 08/08/2022

Human medicines highlights - July 2022

Reference Number: Isssue 160

English (EN) (274.83 KB - PDF)

First published: 18/07/2022

Human medicines highlights - June 2022

Reference Number: Isssue 159

English (EN) (278.67 KB - PDF)

First published: 08/06/2022

Human medicines highlights - April 2022

Reference Number: Isssue 157

English (EN) (262.57 KB - PDF)

First published: 11/04/2022

Human medicines highlights - March 2022

Reference Number: Issue 156

English (EN) (336.87 KB - PDF)

First published: 07/03/2022

Human medicines highlights - February 2022

Reference Number: Issue 155

English (EN) (277.2 KB - PDF)

First published: 04/02/2022

Human medicines highlights - January 2022

Reference Number: Issue 154

English (EN) (282.14 KB - PDF)

First published: 14/01/2022

Human medicines highlights - December 2021

Reference Number: Issue 153

English (EN) (279.74 KB - PDF)

First published: 06/12/2021

Human medicines highlights - November 2021

Reference Number: Issue 152Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

English (EN) (333.27 KB - PDF)

First published: 11/11/2021

Human medicines highlights - October 2021

Reference Number: Issue 151

English (EN) (336.35 KB - PDF)

First published: 07/10/2021

Human medicines highlights - September 2021

Reference Number: Issue 150

English (EN) (239.43 KB - PDF)

First published: 07/09/2021

Human medicines highlights - August 2021

Reference Number: Issue 149

English (EN) (330.45 KB - PDF)

First published: 05/08/2021

Human medicines highlights - July 2021

Reference Number: Issue 148

English (EN) (385.37 KB - PDF)

First published: 06/07/2021

Human medicines highlights - June 2021

Reference Number: Issue 147

English (EN) (399.25 KB - PDF)

First published: 04/06/2021

Human medicines highlights - May 2021

Reference Number: Issue 146

English (EN) (329.31 KB - PDF)

First published: 31/05/2021

Human medicines highlights - April 2021

Reference Number: Issue 145

English (EN) (481.79 KB - PDF)

First published: 14/04/2021

Human medicines highlights - March 2021

Reference Number: Issue 144

English (EN) (272.14 KB - PDF)

First published: 18/03/2021

Human medicines highlights - February 2021

Reference Number: Issue 143

English (EN) (453.49 KB - PDF)

First published: 03/02/2021

Human medicines highlights - January 2021

Reference Number: Issue 142Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

English (EN) (872.45 KB - PDF)

First published: 13/01/2021

Human medicines highlights - December 2020

Reference Number: Issue 141

English (EN) (774.63 KB - PDF)

First published: 10/12/2020

Human medicines highlights - November 2020

Reference Number: Issue 140

English (EN) (628.62 KB - PDF)

First published: 11/11/2020

Human medicines highlights - October 2020

Reference Number: Issue 139

English (EN) (674.99 KB - PDF)

First published: 12/10/2020

Human medicines highlights - September 2020

Reference Number: Issue 138

English (EN) (333.09 KB - PDF)

First published: 04/09/2020

Human medicines highlights - August 2020

Reference Number: Issue 137

English (EN) (621.19 KB - PDF)

First published: 07/08/2020

Human medicines highlights - July 2020

Reference Number: Issue 136

English (EN) (810.96 KB - PDF)

First published: 09/07/2020

Human medicines highlights - June 2020

Reference Number: Issue 135

English (EN) (606.29 KB - PDF)

First published: 08/06/2020

Human medicines highlights - May 2020

Reference Number: Issue 134

English (EN) (352.37 KB - PDF)

First published: 11/05/2020

Human medicines highlights - April 2020

Reference Number: Issue 133

English (EN) (282.67 KB - PDF)

First published: 14/04/2020

Human medicines highlights - March 2020

Reference Number: Issue 132

English (EN) (812.12 KB - PDF)

First published: 11/03/2020

Human medicines highlights - February 2020

Reference Number: Issue 131

English (EN) (488.32 KB - PDF)

First published: 10/02/2020

Human medicines highlights - January 2020

Reference Number: Issue 130

English (EN) (654.41 KB - PDF)

First published: 17/01/2020

Human medicines highlights - December 2019

Reference Number: Issue 129

English (EN) (442.81 KB - PDF)

First published: 10/12/2019

Human medicines highlights - November 2019

Reference Number: Issue 128

English (EN) (335.94 KB - PDF)

First published: 07/11/2019

Human medicines highlights - October 2019

Reference Number: Issue 127

English (EN) (355.34 KB - PDF)

First published: 07/10/2019

Human medicines highlights - September 2019

Reference Number: Issue 126

English (EN) (339.4 KB - PDF)

First published: 11/09/2019

Human medicines highlights - August 2019

Reference Number: Issue 125

English (EN) (396.97 KB - PDF)

First published: 13/08/2019

Human medicines highlights - July 2019

Reference Number: Issue 124

English (EN) (419.77 KB - PDF)

First published: 05/07/2019Last updated: 24/07/2019

Human medicines highlights - June 2019

Reference Number: Issue 123

English (EN) (352.18 KB - PDF)

First published: 06/06/2019

Human medicines highlights - May 2019

Reference Number: Issue 122

English (EN) (337.41 KB - PDF)

First published: 10/05/2019

Human medicines highlights - April 2019

Reference Number: Issue 121

English (EN) (372.19 KB - PDF)

First published: 12/04/2019

Human medicines highlights - March 2019

Reference Number: Issue 120

English (EN) (452.59 KB - PDF)

First published: 06/03/2019

Human medicines highlights - February 2019

Reference Number: Issue 119

English (EN) (389.08 KB - PDF)

First published: 13/02/2019

Human medicines highlights - January 2019

Reference Number: Issue 118

English (EN) (378.06 KB - PDF)

First published: 14/01/2019

Small and Medium-sized Enterprises (SMEs) Highlights

Issues from February 2024 (Issue 61) onwards are available at the link below:

Small and Medium-sized Enterprises (SMEs) Highlights: Issue 61 onwards

Use this link to receive Small and Medium-sized Enterprises (SMEs) Highlights by email:

Subscribe to Small and Medium-sized Enterprises (SMEs) Highlights

Previous issues are available below:

News bulletin for small and medium-sized enterprises - Issue 60

English (EN) (1.33 MB - PDF)

First published: 20/11/2023

News bulletin for small and medium-sized enterprises - Issue 59

English (EN) (1.09 MB - PDF)

First published: 26/07/2023

News bulletin for small and medium-sized enterprises - Issue 58

Reference Number: Issue 58

English (EN) (1.05 MB - PDF)

First published: 28/04/2023

News bulletin for small and medium-sized enterprises - Issue 57

Reference Number: Issue 57

English (EN) (1.04 MB - PDF)

First published: 12/01/2023

News bulletin for small and medium-sized enterprises - Issue 56

Reference Number: Issue 56

English (EN) (1.17 MB - PDF)

First published: 02/08/2022

News bulletin for small and medium-sized enterprises - Issue 55

Reference Number: Issue 55

English (EN) (1.28 MB - PDF)

First published: 17/05/2022

News bulletin for small and medium-sized enterprises - Issue 54

Reference Number: Issue 54

English (EN) (1.08 MB - PDF)

First published: 14/12/2021

News bulletin for small and medium-sized enterprises - Issue 53

Reference Number: Issue 53

English (EN) (1.59 MB - PDF)

First published: 29/07/2021

News bulletin for small and medium-sized enterprises - Issue 52

Reference Number: Issue 52

English (EN) (1.13 MB - PDF)

First published: 19/04/2021

News bulletin for small and medium-sized enterprises - Issue 51

Reference Number: Issue 51Summary:

SME Newsletter - Issue 51

English (EN) (1.32 MB - PDF)

First published: 19/01/2021

News bulletin for small and medium-sized enterprises - Issue 50

Reference Number: Issue 50

English (EN) (537.38 KB - PDF)

First published: 10/09/2020

News bulletin for small and medium-sized enterprises - Issue 49

Reference Number: Issue 49

English (EN) (632.66 KB - PDF)

First published: 07/05/2020

News bulletin for small and medium-sized enterprises - Issue 48

Reference Number: Issue 48

English (EN) (643.01 KB - PDF)

First published: 29/01/2020

News bulletin for small and medium-sized enterprises - Issue 47

Reference Number: Issue 47

English (EN) (687.64 KB - PDF)

First published: 26/08/2019

News bulletin for small and medium-sized enterprises - Issue 46

Reference Number: Issue 46

English (EN) (1.09 MB - PDF)

First published: 08/03/2019

News bulletin for small and medium-sized enterprises - Issue 45

Reference Number: Issue 45

English (EN) (1016.05 KB - PDF)

First published: 23/11/2018

News bulletin for small and medium-sized enterprises - Issue 44

Reference Number: Issue 44Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (580.16 KB - PDF)

First published: 09/08/2018Last updated: 09/08/2018

News bulletin for small and medium-sized enterprises - Issue 43

English (EN) (779.53 KB - PDF)

First published: 14/05/2018Last updated: 14/05/2018

News bulletin for small and medium-sized enterprises - Issue 42

Reference Number: Issue 42

English (EN) (1.35 MB - PDF)

First published: 06/02/2018Last updated: 06/02/2018

News bulletin for small and medium-sized enterprises - Issue 41

English (EN) (796.64 KB - PDF)

First published: 07/11/2017Last updated: 07/11/2017

News bulletin for small and medium-sized enterprises - Issue 40

English (EN) (1007.65 KB - PDF)

First published: 27/07/2017Last updated: 27/07/2017

News bulletin for small and medium-sized enterprises - Issue 39

Reference Number: Issue 39Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (765.33 KB - PDF)

First published: 16/05/2017Last updated: 16/05/2017

News bulletin for small and medium-sized enterprises - Issue 38

English (EN) (771.39 KB - PDF)

First published: 02/02/2017Last updated: 02/02/2017

News bulletin for small and medium-sized enterprises - Issue 37

Reference Number: Issue 37Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (488.74 KB - PDF)

First published: 27/10/2016Last updated: 27/10/2016

News bulletin for small and medium-sized enterprises - Issue 36

Reference Number: Issue 36

English (EN) (846.46 KB - PDF)

First published: 03/08/2016Last updated: 03/08/2016

News bulletin for small and medium-sized enterprises - Issue 35

English (EN) (802.95 KB - PDF)

First published: 29/04/2016Last updated: 29/04/2016

News bulletin for small and medium-sized enterprises - Issue 34

Reference Number: Issue 34Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (597.34 KB - PDF)

First published: 25/01/2016Last updated: 25/01/2016

News bulletin for small and medium-sized enterprises - Issue 33

Reference Number: Issue 33Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (807.15 KB - PDF)

First published: 20/10/2015Last updated: 20/10/2015

News bulletin for small and medium-sized enterprises - Issue 32

Reference Number: Issue 32Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

English (EN) (412.12 KB - PDF)

First published: 30/07/2015Last updated: 30/07/2015

News bulletin for small and medium-sized enterprises - Issue 31

Reference Number: Issue 31

English (EN) (645.42 KB - PDF)

First published: 15/04/2015Last updated: 15/04/2015

News bulletin for small and medium-sized enterprises - Issue 30

Reference Number: Issue 30Summary:

A reflection paper on the requirements for the selection and justification of starting materials in the manufacture of chemical active substances has been adopted.

English (EN) (559.72 KB - PDF)

First published: 28/01/2015Last updated: 28/01/2015

News bulletin for small and medium-sized enterprises - Issue 29

Reference Number: Issue 29Summary:

Annex 6 to ICH guideline Q4B “Evaluation and Recommendation of pharmacopoeial texts for use in the ICH Regions” came into effect in June 2014.

English (EN) (434.49 KB - PDF)

First published: 17/10/2014Last updated: 17/10/2014

News bulletin for small and medium-sized enterprises - Issue 28

Reference Number: Issue 28Summary:

A guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products will come into effect on 1 September 2014 (EMA/CHMP/BWP/85290/2012).

English (EN) (553.51 KB - PDF)

First published: 30/06/2014Last updated: 30/06/2014

News bulletin for small and medium-sized enterprises - Issue 27

Reference Number: Issue 27Summary:

A joint CHMP/CVMP guideline on process validation for finished products will come into effect on 15 June 2014 (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1).

English (EN) (504.77 KB - PDF)

First published: 31/03/2014Last updated: 31/03/2014

News bulletin for small and medium-sized enterprises - Issue 26

Reference Number: Issue 26

English (EN) (334.84 KB - PDF)

First published: 07/01/2014Last updated: 07/01/2014

News bulletin for small and medium-sized enterprises - Issue 25

Reference Number: Issue 25

English (EN) (362.65 KB - PDF)

First published: 08/10/2013Last updated: 08/10/2013

News bulletin for small and medium-sized enterprises - Issue 24

English (EN) (476.79 KB - PDF)

First published: 08/07/2013Last updated: 08/07/2013

News bulletin for small and medium-sized enterprises - Issue 23

English (EN) (316.89 KB - PDF)

First published: 25/03/2013Last updated: 25/03/2013

News bulletin for small and medium-sized enterprises - Issue 22

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (529.78 KB - PDF)

First published: 17/12/2012Last updated: 17/12/2012

News bulletin for small and medium-sized enterprises - Issue 21

English (EN) (327.67 KB - PDF)

First published: 13/09/2012Last updated: 13/09/2012

News bulletin for small and medium-sized enterprises - Issue 20

Reference Number: Issue 20Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (351.11 KB - PDF)

First published: 11/07/2012Last updated: 11/07/2012

News bulletin for small and medium-sized enterprises - Issue 19

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities

related to the European regulatory environment.

English (EN) (504.37 KB - PDF)

First published: 14/03/2012Last updated: 14/03/2012

News bulletin for small and medium-sized enterprises - Issue 18

Summary:

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, ocuments and activities related to the European regulatory environment.

English (EN) (238.95 KB - PDF)

First published: 21/12/2011Last updated: 21/12/2011

News bulletin for small and medium-sized enterprises - Issue 17

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (414.45 KB - PDF)

First published: 19/09/2011Last updated: 19/09/2011

News bulletin for small and medium-sized enterprises - Issue 16

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

English (EN) (602.4 KB - PDF)

First published: 30/06/2011Last updated: 30/06/2011

News bulletin for small and medium-sized enterprises - Issue 15

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

English (EN) (353.32 KB - PDF)

First published: 21/03/2011Last updated: 21/03/2011

What's new in pharmacovigilance

What's new in pharmacovigilance, published four times a year, updates qualified persons for pharmacovigilance on guidance, regulations and events.

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019

Reference Number: Issue 1 - 2019

English (EN) (384.21 KB - PDF)

First published: 09/08/2019

What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018

Reference Number: Issue 2

English (EN) (342.24 KB - PDF)

First published: 07/01/2019

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018

Reference Number: Issue 1Summary:

This qualified persons responsible for pharmacovigilance (QPPV) update provides QPPVs and all other people working in pharmacovigilance with an

update on European Union (EU) pharmacovigilance, relating to

medicines for human use.

English (EN) (373.34 KB - PDF)

First published: 31/07/2018Last updated: 31/07/2018

What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017

Reference Number: Issue 3 - 2017

English (EN) (359.44 KB - PDF)

First published: 21/12/2017Last updated: 21/12/2017

What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017

English (EN) (591.05 KB - PDF)

First published: 09/08/2017Last updated: 09/08/2017

What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017

Reference Number: Issue 1 - 2017

English (EN) (431.62 KB - PDF)

First published: 11/04/2017Last updated: 11/04/2017

What's new in pharmacovigilance - QPPV Update - Issue 3

Reference Number: Issue 3

English (EN) (562.97 KB - PDF)

First published: 22/12/2016Last updated: 22/12/2016

What's new in pharmacovigilance - QPPV Update - Issue 2

Reference Number: Issue 2

English (EN) (594.24 KB - PDF)

First published: 09/08/2016Last updated: 09/08/2016

What's new in pharmacovigilance - QPPV Update - Issue 1

Reference Number: Issue 1

English (EN) (609.89 KB - PDF)

First published: 29/04/2016Last updated: 29/04/2016

News bulletin for pharmacovigilance programme update - Issue 6

Reference Number: Issue 6Summary:

News bulletin for pharmacovigilance programme update

English (EN) (456.55 KB - PDF)

First published: 21/12/2015Last updated: 21/12/2015

News bulletin for pharmacovigilance programme update - Issue 5

Reference Number: Issue 5

English (EN) (514.54 KB - PDF)

First published: 13/10/2015Last updated: 13/10/2015

News bulletin for pharmacovigilance programme update - Issue 4

Reference Number: Issue 4

English (EN) (657.06 KB - PDF)

First published: 03/07/2015Last updated: 03/07/2015

News bulletin for pharmacovigilance programme update - Issue 3

Reference Number: Issue 3

English (EN) (488.45 KB - PDF)

First published: 31/03/2015Last updated: 31/03/2015

Clinical Trials Information System (CTIS) newsflash

EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.

CTIS newsflash - 22 April 2024

Reference Number: EMA/147229/2024

English (EN) (288.05 KB - PDF)

First published: 22/04/2024

CTIS newsflash - 5 April 2024

Reference Number: EMA/128274/2024

English (EN) (288.21 KB - PDF)

First published: 18/04/2024

CTIS newsflash - 22 March 2024

Reference Number: EMA/106948/2024

English (EN) (283.88 KB - PDF)

First published: 22/03/2024

CTIS newsflash - 8 March 2024

Reference Number: EMA/84206/2024

English (EN) (280 KB - PDF)

First published: 11/03/2024

CTIS newsflash - 23 february 2024

Reference Number: EMA/62843/2024

English (EN) (287.63 KB - PDF)

First published: 01/03/2024

CTIS newsflash - 9 February 2024

Reference Number: EMA/43654/2024

English (EN) (297.88 KB - PDF)

First published: 12/02/2024

CTIS newsflash - 26 January 2024

Reference Number: EMA/20807/2024

English (EN) (283.79 KB - PDF)

First published: 29/01/2024

CTIS newsflash – 12 January 2024

Reference Number: EMA/586501/2023

English (EN) (203.45 KB - PDF)

First published: 22/01/2024

CTIS newsflash – 22 December 2023

Reference Number: EMA/564292/2023

English (EN) (775.65 KB - PDF)

First published: 08/01/2024

CTIS newsflash - 8 December 2023

Reference Number: EMA/536032/2023

English (EN) (386.54 KB - PDF)

First published: 12/12/2023

CTIS newsflash – 24 November 2023

English (EN) (546.85 KB - PDF)

First published: 05/12/2023

CTIS newsflash – 10 November 2023

Reference Number: EMA/486111/2023

English (EN) (629.21 KB - PDF)

First published: 10/11/2023

CTIS newsflash – 27 October 2023

Reference Number: EMA/471461/2023

English (EN) (587.53 KB - PDF)

First published: 30/10/2023

CTIS newsflash – 13 October 2023

Reference Number: EMA/440825/2023

English (EN) (633.66 KB - PDF)

First published: 30/10/2023

CTIS newsflash - 29 September 2023

Reference Number: EMA/416454/2023

English (EN) (573.26 KB - PDF)

First published: 02/10/2023

CTIS newsflash - 15 September 2023

Reference Number: EMA/397022/2023

English (EN) (665.42 KB - PDF)

First published: 15/09/2023

CTIS newsflash - 1 September 2023

Reference Number: EMA/376569/2023

English (EN) (455.49 KB - PDF)

First published: 04/09/2023

CTIS newsflash – 18 August 2023

Reference Number: EMA/356297/2023

English (EN) (748.6 KB - PDF)

First published: 18/08/2023

CTIS newsflash - 4 August 2023

Reference Number: EMA/339073/2023

English (EN) (575.83 KB - PDF)

First published: 04/08/2023

CTIS newsflash - 21 July 2023

Reference Number: EMA/293653/2023

English (EN) (615.79 KB - PDF)

First published: 24/07/2023

CTIS newsflash - 7 July 2023

Reference Number: EMA/293590/2023

English (EN) (866.26 KB - PDF)

First published: 12/07/2023

CTIS newsflash – 23 June 2023

English (EN) (747.99 KB - PDF)

First published: 05/07/2023

CTIS newsflash - 9 June 2023

Reference Number: EMA/231823/2023

English (EN) (698.43 KB - PDF)

First published: 12/06/2023

CTIS newsflash - 26 May 2023

Reference Number: EMA/220482/2023

English (EN) (498.48 KB - PDF)

First published: 30/05/2023

CTIS newsflash - 12 May 2023

Reference Number: EMA/209485/2023

English (EN) (438.13 KB - PDF)

First published: 16/05/2023

CTIS newsflash - 5 May 2023

Reference Number: EMA/186032/2023

English (EN) (556.16 KB - PDF)

First published: 08/05/2023

CTIS newsflash - 28 April 2023

Reference Number: EMA/184144/2023

English (EN) (478.03 KB - PDF)

First published: 28/04/2023

CTIS newsflash - 21 April 2023

Reference Number: EMA/171343/2023

English (EN) (446.23 KB - PDF)

First published: 24/04/2023

CTIS newsflash - 14 April 2023

Reference Number: EMA/155249/2023

English (EN) (486.34 KB - PDF)

First published: 14/04/2023

CTIS newsflash – 31 March 2023

Reference Number: EMA/141792/2023

English (EN) (720.22 KB - PDF)

First published: 31/03/2023

CTIS newsflash – 24 March 2023

Reference Number: EMA/127714/2023

English (EN) (648.83 KB - PDF)

First published: 27/03/2023

CTIS newsflash – 17 March 2023

Reference Number: EMA/114900/2023

English (EN) (693.91 KB - PDF)

First published: 17/03/2023

CTIS newsflash - 10 March 2023

Reference Number: EMA/103161/2023

English (EN) (446.06 KB - PDF)

First published: 10/03/2023

CTIS newsflash - 3 March 2023

Reference Number: EMA/89888/2023

English (EN) (455.83 KB - PDF)

First published: 03/03/2023

CTIS newsflash - 24 February 2023

Reference Number: EMA/78479/2023

English (EN) (450.06 KB - PDF)

First published: 27/02/2023

CTIS newsflash - 17 February 2023

Reference Number: EMA/69125/2023

English (EN) (427.99 KB - PDF)

First published: 20/02/2023

CTIS newsflash - 10 February 2023

Reference Number: EMA/58602/2023

English (EN) (494.95 KB - PDF)

First published: 13/02/2023

CTIS newsflash - 3 February 2023

Reference Number: EMA/47266/2023

English (EN) (138.1 KB - PDF)

First published: 03/02/2023

CTIS newsflash - 27 January 2023

Reference Number: EMA/36776/2023

English (EN) (135.5 KB - PDF)

First published: 31/01/2023

CTIS newsflash – 20 January 2023

Reference Number: EMA/23426/2023

English (EN) (315.43 KB - PDF)

First published: 23/01/2023

CTIS newsflash – 13 January 2023

Reference Number: EMA/6441/2023

English (EN) (130.75 KB - PDF)

First published: 13/01/2023

CTIS newsflash - 6 January 2023

Reference Number: EMA/957698/2022

English (EN) (146.13 KB - PDF)

First published: 09/01/2023

CTIS newsflash - 22 December 2022

Reference Number: EMA/940077/2022

English (EN) (117.45 KB - PDF)

First published: 05/01/2023

CTIS newsflash - 12 December 2022

English (EN) (138.36 KB - PDF)

First published: 22/12/2022

CTIS newsflash - 5 December 2022

English (EN) (146.31 KB - PDF)

First published: 22/12/2022

CTIS newsflash - 22 April 2022

English (EN) (117.57 KB - PDF)

First published: 25/04/2022

CTIS newsflash - 8 April 2022

English (EN) (120.71 KB - PDF)

First published: 11/04/2022

CTIS newsflash - 1 April 2022

Reference Number: EMA/193739/2022

English (EN) (118.91 KB - PDF)

First published: 05/04/2022

CTIS newsflash - 25 March 2022

Reference Number: EMA/183329/2022

English (EN) (134.03 KB - PDF)

First published: 28/03/2022

CTIS newsflash - 18 March 2022

Reference Number: EMA/168795/2022

English (EN) (131.93 KB - PDF)

First published: 21/03/2022

CTIS newsflash - 11 March 2022

Reference Number: EMA/149078/2022

English (EN) (138.49 KB - PDF)

First published: 14/03/2022

CTIS newsflash - 4 March 2022

Reference Number: EMA/131960/2022

English (EN) (150.3 KB - PDF)

First published: 08/03/2022

CTIS newsflash - 25 February 2022

Reference Number: EMA/119802/2022

English (EN) (123 KB - PDF)

First published: 01/03/2022

CTIS newsflash - 18 February 2022

Reference Number: EMA/104967/2022

English (EN) (122.89 KB - PDF)

First published: 23/02/2022

CTIS newsflash - 11 February 2022

Reference Number: EMA/83300/2022

English (EN) (117.93 KB - PDF)

First published: 15/02/2022

CTIS newsflash - 4 February 2022

Reference Number: EMA/70002/2022

English (EN) (122.42 KB - PDF)

First published: 07/02/2022

Clinical Trials Highlights

Issues from July 2023 (Issue 15) onwards are available at the link below:

Clinical Trials Highlights: Issue 15 onwards

Use this link to receive Clinical Trials Highlights by email:

Subscribe to Clinical Trials Highlights

Previous issues are available below:

Clinical Trials Highlights - April 2023

Reference Number: Issue 14

English (EN) (1023.34 KB - PDF)

First published: 24/04/2023

Clinical Trials Highlights - February 2023

Reference Number: Issue 13

English (EN) (1.63 MB - PDF)

First published: 20/02/2023

Clinical Trials Highlights - December 2022

Reference Number: Issue 12

English (EN) (1.15 MB - PDF)

First published: 20/12/2022Last updated: 21/12/2022

Clinical Trials Highlights - October 2022

Reference Number: Issue 11

English (EN) (706.31 KB - PDF)

First published: 21/10/2022

Clinical Trials Highlights - July 2022

Reference Number: Issue 10

English (EN) (864.72 KB - PDF)

First published: 25/07/2022

Clinical Trials Highlights - May 2022

Reference Number: Issue 9

English (EN) (520.75 KB - PDF)

First published: 25/05/2022

Clinical Trials Highlights - March 2022

Reference Number: Issue 8

English (EN) (546.63 KB - PDF)

First published: 25/03/2022

Clinical Trials Information System (CTIS) highlights - January 2022

Reference Number: Issue 7

English (EN) (543.39 KB - PDF)

First published: 27/01/2022

Clinical Trials Information System (CTIS) highlights - December 2021

Reference Number: Issue 6

English (EN) (677.31 KB - PDF)

First published: 13/12/2021

Clinical Trials Information System (CTIS) highlights - October 2021

Reference Number: Issue 5

English (EN) (615.7 KB - PDF)

First published: 18/10/2021

Clinical Trials Information System (CTIS) highlights - August 2021

Reference Number: Issue 4

English (EN) (521.49 KB - PDF)

First published: 06/08/2021

Clinical Trials Information System (CTIS) highlights - June 2021

Reference Number: Issue 3

English (EN) (1.03 MB - PDF)

First published: 23/06/2021Last updated: 30/07/2021

Clinical Trials Information System (CTIS) highlights - December 2020

Reference Number: Issue 2

English (EN) (979.81 KB - PDF)

First published: 09/12/2020

Clinical Trials Information System (CTIS) highlights - June 2020

Reference Number: Issue 1

English (EN) (1.52 MB - PDF)

First published: 03/07/2020

Veterinary Medicines Highlights

Issues from September 2023 (Issue 13) onwards are available at the link below:

Veterinary Medicines Highlights: Issue 13 onwards

Use this link to receive Veterinary Medicines Highlights by email:

Subscribe to Veterinary Medicines Highlights

Previous issues are available below:

Veterinary Medicines Highlights - Issue 12

Reference Number: Issue 12

English (EN) (568.62 KB - PDF)

First published: 02/06/2023

Veterinary Medicinal Products Regulation highlights - Issue 11

Reference Number: Issue 11

English (EN) (674.83 KB - PDF)

First published: 27/09/2022

Veterinary Medicinal Products Regulation highlights - Issue 10

Reference Number: Issue 10

English (EN) (1.07 MB - PDF)

First published: 17/05/2022

Veterinary Medicinal Products Regulation highlights - Issue 9

Reference Number: Issue 9

English (EN) (1.05 MB - PDF)

First published: 07/02/2022

Veterinary Medicinal Products Regulation highlights - Issue 8

Reference Number: Issue 8

English (EN) (831.88 KB - PDF)

First published: 29/11/2021

Veterinary Medicinal Products Regulation highlights - Issue 7

Reference Number: Issue 7

English (EN) (843.44 KB - PDF)

First published: 01/10/2021

Veterinary Medicinal Products Regulation highlights - Issue 6

Reference Number: Issue 6Summary:

News, views and interviews for the Veterinary Medicinal Products Regulation. Published every two months by the European Medicines Agency

English (EN) (1.2 MB - PDF)

First published: 29/07/2021

Veterinary Medicinal Products Regulation highlights - Issue 5

Reference Number: Issue 5

English (EN) (1.02 MB - PDF)

First published: 31/05/2021

Veterinary Medicinal Products Regulation highlights - Issue 4

Reference Number: Issue 4

English (EN) (1.2 MB - PDF)

First published: 31/03/2021

Veterinary Medicinal Products Regulation highlights - Issue 3

Reference Number: Issue 3

English (EN) (865.91 KB - PDF)

First published: 28/01/2021

Veterinary Medicines Regulation highlights - Issue 2

Reference Number: Issue 2

English (EN) (980.07 KB - PDF)

First published: 30/10/2020

Veterinary Medicines Regulation highlights - Issue 1

Reference Number: Issue 1Summary:

News, views and interviews for the Veterinary Medicines Regulation. Published four times a year by the European Medicines Agency.

English (EN) (798.65 KB - PDF)

First published: 17/07/2020

Big Data Highlights

Issues from June 2023 (Issue 6) onwards are available at the link below:

Big Data Highlights: Issue 6 onwards

Use this link to receive Big Data Highlights by email:

Subscribe to Big Data Highlights

Previous issues from 2022 are available below:

Big Data highlights - Issue 1

Reference Number: Issue 1

English (EN) (1.07 MB - PDF)

First published: 15/02/2022

Big Data highlights - Issue 2

Reference Number: Issue 2

English (EN) (1.29 MB - PDF)

First published: 24/05/2022

Big Data highlights - Issue 3

Reference Number: Issue 3

English (EN) (672.36 KB - PDF)

First published: 06/08/2022

Big Data highlights - Issue 4

Reference Number: Issue 4

English (EN) (936.3 KB - PDF)

First published: 14/12/2022

Big Data highlights - Issue 5

Reference Number: Issue 5

English (EN) (639.6 KB - PDF)

First published: 31/03/2023

The electronic Application Form (eAF) - Product Management Service (PMS) newsletter provides pharmaceutical companies and national competent authorities in the EU updates on the progress of the eAF and PMS products. It also includes an overview of upcoming events and information on available resources.

The objective of the eAF product is to replace PDF eAFs used for regulatory submissions with online forms available on the Product Lifecycle Management (PLM) Portal, in order to make completing and handling applications more efficient.

For more information, see:

The Product Management Service (PMS) makes available comprehensive and consolidated data on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs) from different sources across the European Medicines Regulatory Network.

The data can be re-used in electronic applications and throughout regulatory processes.

For more information, see:

Substance and product data management services

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3

Reference Number: Issue 3

English (EN) (1.34 MB - PDF)

First published: 15/05/2023

Electronic Application Form (eAF) newsletter - Issue 2

Reference Number: Issue 2

English (EN) (717.9 KB - PDF)

First published: 21/12/2022Last updated: 10/01/2023

Digital Application Dataset Integration (DADI) newsletter - Issue 1

Reference Number: Issue 1

English (EN) (548.17 KB - PDF)

First published: 26/07/2022

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