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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:

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

Human medicines highlights - March 2024

Human medicines highlights - February 2024

Human medicines highlights - January 2024

Human medicines highlights - November-December 2023

Human medicines highlights - October 2023

Human medicines highlights - September 2023

Human medicines highlights - August 2023

Human medicines highlights - June 2023

Human medicines highlights - May 2023

Human medicines highlights - April 2023

Human medicines highlights - March 2023

Human medicines highlights - February 2023

Human medicines highlights - January 2023

Human medicines highlights - December 2022

Human medicines highlights - November 2022

Human medicines highlights - September 2022

Human medicines highlights - August 2022

Human medicines highlights - July 2022

Human medicines highlights - June 2022

Human medicines highlights - April 2022

Human medicines highlights - March 2022

Human medicines highlights - February 2022

Human medicines highlights - January 2022

Human medicines highlights - December 2021

Human medicines highlights - November 2021

Human medicines highlights - October 2021

Human medicines highlights - September 2021

Human medicines highlights - August 2021

Human medicines highlights - July 2021

Human medicines highlights - June 2021

Human medicines highlights - May 2021

Human medicines highlights - April 2021

Human medicines highlights - March 2021

Human medicines highlights - February 2021

Human medicines highlights - January 2021

Human medicines highlights - December 2020

Human medicines highlights - November 2020

Human medicines highlights - October 2020

Human medicines highlights - September 2020

Human medicines highlights - August 2020

Human medicines highlights - July 2020

Human medicines highlights - June 2020

Human medicines highlights - May 2020

Human medicines highlights - April 2020

Human medicines highlights - March 2020

Human medicines highlights - February 2020

Human medicines highlights - January 2020

Human medicines highlights - December 2019

Human medicines highlights - November 2019

Human medicines highlights - October 2019

Human medicines highlights - September 2019

Human medicines highlights - August 2019

Human medicines highlights - July 2019

Human medicines highlights - June 2019

Human medicines highlights - May 2019

Human medicines highlights - April 2019

Human medicines highlights - March 2019

Human medicines highlights - February 2019

Human medicines highlights - January 2019

Small and Medium-sized Enterprises (SMEs) Highlights

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

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

Previous issues are available below:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

News bulletin for pharmacovigilance programme update - Issue 6

News bulletin for pharmacovigilance programme update - Issue 5

News bulletin for pharmacovigilance programme update - Issue 4

News bulletin for pharmacovigilance programme update - Issue 3

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 March 2024

CTIS newsflash - 8 March 2024

CTIS newsflash - 23 february 2024

CTIS newsflash - 9 February 2024

CTIS newsflash - 26 January 2024

CTIS newsflash – 12 January 2024

CTIS newsflash – 22 December 2023

CTIS newsflash - 8 December 2023

CTIS newsflash – 24 November 2023

CTIS newsflash – 10 November 2023

CTIS newsflash – 27 October 2023

CTIS newsflash – 13 October 2023

CTIS newsflash - 29 September 2023

CTIS newsflash - 15 September 2023

CTIS newsflash - 1 September 2023

CTIS newsflash – 18 August 2023

CTIS newsflash - 4 August 2023

CTIS newsflash - 21 July 2023

CTIS newsflash - 7 July 2023

CTIS newsflash – 23 June 2023

CTIS newsflash - 9 June 2023

CTIS newsflash - 26 May 2023

CTIS newsflash - 12 May 2023

CTIS newsflash - 5 May 2023

CTIS newsflash - 28 April 2023

CTIS newsflash - 21 April 2023

CTIS newsflash - 14 April 2023

CTIS newsflash – 31 March 2023

CTIS newsflash – 24 March 2023

CTIS newsflash – 17 March 2023

CTIS newsflash - 10 March 2023

CTIS newsflash - 3 March 2023

CTIS newsflash - 24 February 2023

CTIS newsflash - 17 February 2023

CTIS newsflash - 10 February 2023

CTIS newsflash - 3 February 2023

CTIS newsflash - 27 January 2023

CTIS newsflash – 20 January 2023

CTIS newsflash – 13 January 2023

CTIS newsflash - 6 January 2023

CTIS newsflash - 22 December 2022

CTIS newsflash - 12 December 2022

CTIS newsflash - 5 December 2022

CTIS newsflash - 22 April 2022

CTIS newsflash - 8 April 2022

CTIS newsflash - 1 April 2022

CTIS newsflash - 25 March 2022

CTIS newsflash - 18 March 2022

CTIS newsflash - 11 March 2022

CTIS newsflash - 4 March 2022

CTIS newsflash - 25 February 2022

CTIS newsflash - 18 February 2022

CTIS newsflash - 11 February 2022

CTIS newsflash - 4 February 2022

Clinical Trials Highlights

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

Use this link to receive Clinical Trials Highlights by email:

Previous issues are available below:

Clinical Trials Highlights - April 2023

Clinical Trials Highlights - February 2023

Clinical Trials Highlights - December 2022

Clinical Trials Highlights - October 2022

Clinical Trials Highlights - July 2022

Clinical Trials Highlights - May 2022

Clinical Trials Highlights - March 2022

Clinical Trials Information System (CTIS) highlights - January 2022

Clinical Trials Information System (CTIS) highlights - December 2021

Clinical Trials Information System (CTIS) highlights - October 2021

Clinical Trials Information System (CTIS) highlights - August 2021

Clinical Trials Information System (CTIS) highlights - June 2021

Clinical Trials Information System (CTIS) highlights - December 2020

 

Clinical Trials Information System (CTIS) highlights - June 2020

Veterinary Medicines Highlights

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

Use this link to receive Veterinary Medicines Highlights by email: 

Previous issues are available below: 

Veterinary Medicines Highlights - Issue 12

Veterinary Medicinal Products Regulation highlights - Issue 11

Veterinary Medicinal Products Regulation highlights - Issue 10

Veterinary Medicinal Products Regulation highlights - Issue 9

Veterinary Medicinal Products Regulation highlights - Issue 8

Veterinary Medicinal Products Regulation highlights - Issue 7

Veterinary Medicinal Products Regulation highlights - Issue 6

Veterinary Medicinal Products Regulation highlights - Issue 5

Veterinary Medicinal Products Regulation highlights - Issue 4

Veterinary Medicinal Products Regulation highlights - Issue 3

Veterinary Medicines Regulation highlights - Issue 2

Veterinary Medicines Regulation highlights - Issue 1

Big Data Highlights

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

Use this link to receive Big Data Highlights by email: 

Previous issues from 2022 are available below: 

Big Data highlights - Issue 1

Big Data highlights - Issue 2

Big Data highlights - Issue 3

 

Big Data highlights - Issue 4

Big Data highlights - Issue 5

 

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

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:

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

Electronic Application Form (eAF) newsletter - Issue 2

Digital Application Dataset Integration (DADI) newsletter - Issue 1

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