Newsletter archive

Archive of the European Medicines Agency (EMA)'s discontinued newsletters
HumanVeterinaryData on medicinesPharmacovigilanceSME

Clinical Trials Information System (CTIS) newsflash (discontinued)

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

From July 2025, the CTIS newsflash is replaced by Clinical Trials Highlights Newsletter.

CTIS newsflash – 24 June 2025

Reference Number: EMA/198062/2025

English (EN) (3.78 MB - PDF)

First published:
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Select the expandable panel below to access issues published between 2022 and 2025:

CTIS newsflash - 10 June 2025

Reference Number: EMA/179146/2025

English (EN) (3.83 MB - PDF)

First published:
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CTIS newsflash - 27 May 2025

Reference Number: EMA/175583/2025

English (EN) (107.33 KB - PDF)

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CTIS newsflash - 16 May 2025

English (EN) (179.08 KB - PDF)

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CTIS newsflash - 29 April 2025

Reference Number: EMA/124649/2025

English (EN) (196.88 KB - PDF)

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CTIS newsflash - 25 March 2025

Reference Number: EMA/90566/2025

English (EN) (123.11 KB - PDF)

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CTIS newsflash - 11 March 2025

Reference Number: EMA/72075/2025

English (EN) (159.68 KB - PDF)

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CTIS newsflash - 25 February 2025

Reference Number: EMA/36861/2025

English (EN) (109.98 KB - PDF)

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CTIS newsflash – 11 February 2025

Reference Number: EMA/37270/2025

English (EN) (470.46 KB - PDF)

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CTIS newsflash – 28 January 2025

Reference Number: EMA/7145/2025

English (EN) (107.01 KB - PDF)

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CTIS newsflash - 14 January 2025

Reference Number: EMA/582910/2024

English (EN) (201.78 KB - PDF)

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CTIS newsflash - 17 December 2024

Reference Number: EMA/559561/2024

English (EN) (847.74 KB - PDF)

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CTIS newsflash - 3 December 2024

Reference Number: EMA/541301/2024

English (EN) (134.77 KB - PDF)

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CTIS newsflash - 19 November 2024

Reference Number: EMA/514303/2024

English (EN) (190.05 KB - PDF)

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CTIS newsflash - 5 November 2024

Reference Number: EMA/501426/2024

English (EN) (130.81 KB - PDF)

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CTIS newsflash - 22 October 2024

Reference Number: EMA/469994/2024

English (EN) (169.46 KB - PDF)

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CTIS newsflash - 8 October 2024

Reference Number: EMA/441928/2024

English (EN) (241.28 KB - PDF)

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CTIS newsflash - 24 September 2024

Reference Number: EMA/421508/2024

English (EN) (136.16 KB - PDF)

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CTIS newsflash - 10 September 2024

Reference Number: EMA/374537/2024

English (EN) (284.04 KB - PDF)

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CTIS newsflash - 9 August 2024

Reference Number: EMA/325160/2024

English (EN) (286.51 KB - PDF)

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CTIS newsflash - 26 July 2024

Reference Number: EMA/334159/2024

English (EN) (1.09 MB - PDF)

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CTIS newsflash - 12 July 2024

Reference Number: EMA/303545/2024

English (EN) (286.47 KB - PDF)

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CTIS newsflash - 28 June 2024

Reference Number: EMA/291916/2024

English (EN) (296.68 KB - PDF)

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CTIS newsflash – 14 June 2024

Reference Number: EMA/264069/2024

English (EN) (410.44 KB - PDF)

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CTIS newsflash - 31 May 2024

Reference Number: EMA/240597/2024

English (EN) (277.61 KB - PDF)

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CTIS newsflash - 17 May 2024

Reference Number: EMA/162262/2024

English (EN) (478.28 KB - PDF)

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CTIS newsflash – 3 May 2024

Reference Number: EMA/174397/2024

English (EN) (473.1 KB - PDF)

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CTIS newsflash - 22 April 2024

Reference Number: EMA/147229/2024

English (EN) (288.05 KB - PDF)

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CTIS newsflash - 5 April 2024

Reference Number: EMA/128274/2024

English (EN) (288.21 KB - PDF)

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CTIS newsflash - 22 March 2024

Reference Number: EMA/106948/2024

English (EN) (283.88 KB - PDF)

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CTIS newsflash - 8 March 2024

Reference Number: EMA/84206/2024

English (EN) (280 KB - PDF)

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CTIS newsflash - 23 february 2024

Reference Number: EMA/62843/2024

English (EN) (287.63 KB - PDF)

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CTIS newsflash - 9 February 2024

Reference Number: EMA/43654/2024

English (EN) (297.88 KB - PDF)

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CTIS newsflash - 26 January 2024

Reference Number: EMA/20807/2024

English (EN) (283.79 KB - PDF)

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CTIS newsflash – 12 January 2024

Reference Number: EMA/586501/2023

English (EN) (203.45 KB - PDF)

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CTIS newsflash – 22 December 2023

Reference Number: EMA/564292/2023

English (EN) (775.65 KB - PDF)

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CTIS newsflash - 8 December 2023

Reference Number: EMA/536032/2023

English (EN) (386.54 KB - PDF)

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CTIS newsflash – 24 November 2023

English (EN) (546.85 KB - PDF)

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CTIS newsflash – 10 November 2023

Reference Number: EMA/486111/2023

English (EN) (629.21 KB - PDF)

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CTIS newsflash – 27 October 2023

Reference Number: EMA/471461/2023

English (EN) (587.53 KB - PDF)

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CTIS newsflash – 13 October 2023

Reference Number: EMA/440825/2023

English (EN) (633.66 KB - PDF)

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CTIS newsflash - 29 September 2023

Reference Number: EMA/416454/2023

English (EN) (573.26 KB - PDF)

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CTIS newsflash - 15 September 2023

Reference Number: EMA/397022/2023

English (EN) (665.42 KB - PDF)

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CTIS newsflash - 1 September 2023

Reference Number: EMA/376569/2023

English (EN) (455.49 KB - PDF)

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CTIS newsflash – 18 August 2023

Reference Number: EMA/356297/2023

English (EN) (748.6 KB - PDF)

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CTIS newsflash - 4 August 2023

Reference Number: EMA/339073/2023

English (EN) (575.83 KB - PDF)

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CTIS newsflash - 21 July 2023

Reference Number: EMA/293653/2023

English (EN) (615.79 KB - PDF)

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CTIS newsflash - 7 July 2023

Reference Number: EMA/293590/2023

English (EN) (866.26 KB - PDF)

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CTIS newsflash – 23 June 2023

English (EN) (747.99 KB - PDF)

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CTIS newsflash - 9 June 2023

Reference Number: EMA/231823/2023

English (EN) (698.43 KB - PDF)

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CTIS newsflash - 26 May 2023

Reference Number: EMA/220482/2023

English (EN) (498.48 KB - PDF)

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CTIS newsflash - 12 May 2023

Reference Number: EMA/209485/2023

English (EN) (438.13 KB - PDF)

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CTIS newsflash - 5 May 2023

Reference Number: EMA/186032/2023

English (EN) (556.16 KB - PDF)

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CTIS newsflash - 28 April 2023

Reference Number: EMA/184144/2023

English (EN) (478.03 KB - PDF)

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CTIS newsflash - 21 April 2023

Reference Number: EMA/171343/2023

English (EN) (446.23 KB - PDF)

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CTIS newsflash - 14 April 2023

Reference Number: EMA/155249/2023

English (EN) (486.34 KB - PDF)

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CTIS newsflash – 31 March 2023

Reference Number: EMA/141792/2023

English (EN) (720.22 KB - PDF)

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CTIS newsflash – 24 March 2023

Reference Number: EMA/127714/2023

English (EN) (648.83 KB - PDF)

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CTIS newsflash – 17 March 2023

Reference Number: EMA/114900/2023

English (EN) (693.91 KB - PDF)

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CTIS newsflash - 10 March 2023

Reference Number: EMA/103161/2023

English (EN) (446.06 KB - PDF)

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CTIS newsflash - 3 March 2023

Reference Number: EMA/89888/2023

English (EN) (455.83 KB - PDF)

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CTIS newsflash - 24 February 2023

Reference Number: EMA/78479/2023

English (EN) (450.06 KB - PDF)

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CTIS newsflash - 17 February 2023

Reference Number: EMA/69125/2023

English (EN) (427.99 KB - PDF)

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CTIS newsflash - 10 February 2023

Reference Number: EMA/58602/2023

English (EN) (494.95 KB - PDF)

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CTIS newsflash - 3 February 2023

Reference Number: EMA/47266/2023

English (EN) (138.1 KB - PDF)

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CTIS newsflash - 27 January 2023

Reference Number: EMA/36776/2023

English (EN) (135.5 KB - PDF)

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CTIS newsflash – 20 January 2023

Reference Number: EMA/23426/2023

English (EN) (315.43 KB - PDF)

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CTIS newsflash – 13 January 2023

Reference Number: EMA/6441/2023

English (EN) (130.75 KB - PDF)

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CTIS newsflash - 6 January 2023

Reference Number: EMA/957698/2022

English (EN) (146.13 KB - PDF)

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CTIS newsflash - 22 December 2022

Reference Number: EMA/940077/2022

English (EN) (117.45 KB - PDF)

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CTIS newsflash - 12 December 2022

English (EN) (138.36 KB - PDF)

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CTIS newsflash - 5 December 2022

English (EN) (146.31 KB - PDF)

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CTIS newsflash - 22 April 2022

English (EN) (117.57 KB - PDF)

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CTIS newsflash - 8 April 2022

English (EN) (120.71 KB - PDF)

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CTIS newsflash - 1 April 2022

Reference Number: EMA/193739/2022

English (EN) (118.91 KB - PDF)

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CTIS newsflash - 25 March 2022

Reference Number: EMA/183329/2022

English (EN) (134.03 KB - PDF)

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CTIS newsflash - 18 March 2022

Reference Number: EMA/168795/2022

English (EN) (131.93 KB - PDF)

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CTIS newsflash - 11 March 2022

Reference Number: EMA/149078/2022

English (EN) (138.49 KB - PDF)

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CTIS newsflash - 4 March 2022

Reference Number: EMA/131960/2022

English (EN) (150.3 KB - PDF)

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CTIS newsflash - 25 February 2022

Reference Number: EMA/119802/2022

English (EN) (123 KB - PDF)

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CTIS newsflash - 18 February 2022

Reference Number: EMA/104967/2022

English (EN) (122.89 KB - PDF)

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CTIS newsflash - 11 February 2022

Reference Number: EMA/83300/2022

English (EN) (117.93 KB - PDF)

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CTIS newsflash - 4 February 2022

Reference Number: EMA/70002/2022

English (EN) (122.42 KB - PDF)

First published:
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Pharmacovigilance newsletter (discontinued)

'What's new in pharmacovigilance' provided regular updates on guidance, regulations and events. EMA has replaced this newsletter with targeted communications to qualified persons for pharmacovigilance (QPPV) as needed.

Select the expandable panel below to access all issues published between 2014 and 2019:

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

Reference Number: Issue 1 - 2019

English (EN) (384.21 KB - PDF)

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

Reference Number: Issue 2

English (EN) (342.24 KB - PDF)

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

Reference Number: Issue 1 Summary:

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

Reference Number: Issue 3 - 2017

English (EN) (359.44 KB - PDF)

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

English (EN) (591.05 KB - PDF)

First published: Last updated:
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What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017

Reference Number: Issue 1 - 2017

English (EN) (431.62 KB - PDF)

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

Reference Number: Issue 3

English (EN) (562.97 KB - PDF)

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

Reference Number: Issue 2

English (EN) (594.24 KB - PDF)

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

Reference Number: Issue 1

English (EN) (609.89 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 6

Reference Number: Issue 6 Summary:

News bulletin for pharmacovigilance programme update

English (EN) (456.55 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 5

Reference Number: Issue 5

English (EN) (514.54 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 4

Reference Number: Issue 4

English (EN) (657.06 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 3

Reference Number: Issue 3

English (EN) (488.45 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 2

Reference Number: Issue 2 Summary:

This second Pharmacovigilance Programme Update is primarily aimed at providing marketing authorisation holders (MAHs) with information to help prepare for the business change to come.

English (EN) (753.86 KB - PDF)

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News bulletin for pharmacovigilance programme update - Issue 1

Reference Number: Issue 1 Summary:

This Update is the first in a series of documents primarily aimed at providing marketingauthorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to

come.

English (EN) (786.75 KB - PDF)

First published: Last updated:
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Electronic Application Form (eAF) - Product Management Service (PMS) newsletter (discontinued)

EMA discontinued the electronic Application Form (eAF) - Product Management Service (PMS) newsletter in 2023.

News on the eAF and PMS products can be found in the newsletter Product Lifecycle Management Insights.

For more information on PLM and PMS, please see:

Select the expandable panel below to access the issues published between 2022 and 2023:

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

Reference Number: Issue 3

English (EN) (1.34 MB - PDF)

First published:
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Electronic Application Form (eAF) newsletter - Issue 2

Reference Number: Issue 2

English (EN) (717.9 KB - PDF)

First published: Last updated:
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Digital Application Dataset Integration (DADI) newsletter - Issue 1

Reference Number: Issue 1

English (EN) (548.17 KB - PDF)

First published:
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