Also on this topic
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 - April 2024
English (EN) (325.35 KB - PDF)
Human medicines highlights - March 2024
English (EN) (352.99 KB - PDF)
Human medicines highlights - February 2024
English (EN) (236.57 KB - PDF)
Human medicines highlights - January 2024
English (EN) (248.32 KB - PDF)
Human medicines highlights - November-December 2023
English (EN) (387.8 KB - PDF)
Human medicines highlights - October 2023
English (EN) (329.23 KB - PDF)
Human medicines highlights - September 2023
English (EN) (274.2 KB - PDF)
Human medicines highlights - August 2023
English (EN) (285.65 KB - PDF)
Human medicines highlights - June 2023
English (EN) (305.45 KB - PDF)
Human medicines highlights - May 2023
English (EN) (371.05 KB - PDF)
Human medicines highlights - April 2023
English (EN) (356.44 KB - PDF)
Human medicines highlights - March 2023
English (EN) (340.59 KB - PDF)
Human medicines highlights - February 2023
English (EN) (273.8 KB - PDF)
Human medicines highlights - January 2023
English (EN) (339.17 KB - PDF)
Human medicines highlights - December 2022
English (EN) (342.63 KB - PDF)
Human medicines highlights - November 2022
English (EN) (284.79 KB - PDF)
Human medicines highlights - September 2022
English (EN) (449.35 KB - PDF)
Human medicines highlights - August 2022
English (EN) (347.93 KB - PDF)
Human medicines highlights - July 2022
English (EN) (274.83 KB - PDF)
Human medicines highlights - June 2022
English (EN) (278.67 KB - PDF)
Human medicines highlights - April 2022
English (EN) (262.57 KB - PDF)
Human medicines highlights - March 2022
English (EN) (336.87 KB - PDF)
Human medicines highlights - February 2022
English (EN) (277.2 KB - PDF)
Human medicines highlights - January 2022
English (EN) (282.14 KB - PDF)
Human medicines highlights - December 2021
English (EN) (279.74 KB - PDF)
Human medicines highlights - November 2021
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)
Human medicines highlights - October 2021
English (EN) (336.35 KB - PDF)
Human medicines highlights - September 2021
English (EN) (239.43 KB - PDF)
Human medicines highlights - August 2021
English (EN) (330.45 KB - PDF)
Human medicines highlights - July 2021
English (EN) (385.37 KB - PDF)
Human medicines highlights - June 2021
English (EN) (399.25 KB - PDF)
Human medicines highlights - May 2021
English (EN) (329.31 KB - PDF)
Human medicines highlights - April 2021
English (EN) (481.79 KB - PDF)
Human medicines highlights - March 2021
English (EN) (272.14 KB - PDF)
Human medicines highlights - February 2021
English (EN) (453.49 KB - PDF)
Human medicines highlights - January 2021
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)
Human medicines highlights - December 2020
English (EN) (774.63 KB - PDF)
Human medicines highlights - November 2020
English (EN) (628.62 KB - PDF)
Human medicines highlights - October 2020
English (EN) (674.99 KB - PDF)
Human medicines highlights - September 2020
English (EN) (333.09 KB - PDF)
Human medicines highlights - August 2020
English (EN) (621.19 KB - PDF)
Human medicines highlights - July 2020
English (EN) (810.96 KB - PDF)
Human medicines highlights - June 2020
English (EN) (606.29 KB - PDF)
Human medicines highlights - May 2020
English (EN) (352.37 KB - PDF)
Human medicines highlights - April 2020
English (EN) (282.67 KB - PDF)
Human medicines highlights - March 2020
English (EN) (812.12 KB - PDF)
Human medicines highlights - February 2020
English (EN) (488.32 KB - PDF)
Human medicines highlights - January 2020
English (EN) (654.41 KB - PDF)
Human medicines highlights - December 2019
English (EN) (442.81 KB - PDF)
Human medicines highlights - November 2019
English (EN) (335.94 KB - PDF)
Human medicines highlights - October 2019
English (EN) (355.34 KB - PDF)
Human medicines highlights - September 2019
English (EN) (339.4 KB - PDF)
Human medicines highlights - August 2019
English (EN) (396.97 KB - PDF)
Human medicines highlights - July 2019
English (EN) (419.77 KB - PDF)
Human medicines highlights - June 2019
English (EN) (352.18 KB - PDF)
Human medicines highlights - May 2019
English (EN) (337.41 KB - PDF)
Human medicines highlights - April 2019
English (EN) (372.19 KB - PDF)
Human medicines highlights - March 2019
English (EN) (452.59 KB - PDF)
Human medicines highlights - February 2019
English (EN) (389.08 KB - PDF)
Human medicines highlights - January 2019
English (EN) (378.06 KB - PDF)
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
English (EN) (1.33 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 59
English (EN) (1.09 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 58
English (EN) (1.05 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 57
English (EN) (1.04 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 56
English (EN) (1.17 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 55
English (EN) (1.28 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 54
English (EN) (1.08 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 53
English (EN) (1.59 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 52
English (EN) (1.13 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 51
SME Newsletter - Issue 51
English (EN) (1.32 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 50
English (EN) (537.38 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 49
English (EN) (632.66 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 48
English (EN) (643.01 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 47
English (EN) (687.64 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 46
English (EN) (1.09 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 45
English (EN) (1016.05 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 44
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)
News bulletin for small and medium-sized enterprises - Issue 43
English (EN) (779.53 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 42
English (EN) (1.35 MB - PDF)
News bulletin for small and medium-sized enterprises - Issue 41
English (EN) (796.64 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 40
English (EN) (1007.65 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 39
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)
News bulletin for small and medium-sized enterprises - Issue 38
English (EN) (771.39 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 37
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)
News bulletin for small and medium-sized enterprises - Issue 36
English (EN) (846.46 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 35
English (EN) (802.95 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 34
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)
News bulletin for small and medium-sized enterprises - Issue 33
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)
News bulletin for small and medium-sized enterprises - Issue 32
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)
News bulletin for small and medium-sized enterprises - Issue 31
English (EN) (645.42 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 30
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)
News bulletin for small and medium-sized enterprises - Issue 29
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)
News bulletin for small and medium-sized enterprises - Issue 28
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)
News bulletin for small and medium-sized enterprises - Issue 27
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)
News bulletin for small and medium-sized enterprises - Issue 26
English (EN) (334.84 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 25
English (EN) (362.65 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 24
English (EN) (476.79 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 23
English (EN) (316.89 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 22
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)
News bulletin for small and medium-sized enterprises - Issue 21
English (EN) (327.67 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 20
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)
News bulletin for small and medium-sized enterprises - Issue 19
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)
News bulletin for small and medium-sized enterprises - Issue 18
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)
News bulletin for small and medium-sized enterprises - Issue 17
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)
News bulletin for small and medium-sized enterprises - Issue 16
This news bulletin is published four times a year by the SME Office of the European Medicines Agency.
English (EN) (602.4 KB - PDF)
News bulletin for small and medium-sized enterprises - Issue 15
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)
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
English (EN) (384.21 KB - PDF)
What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018
English (EN) (342.24 KB - PDF)
What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018
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)
What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017
English (EN) (359.44 KB - PDF)
What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017
English (EN) (591.05 KB - PDF)
What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017
English (EN) (431.62 KB - PDF)
What's new in pharmacovigilance - QPPV Update - Issue 3
English (EN) (562.97 KB - PDF)
What's new in pharmacovigilance - QPPV Update - Issue 2
English (EN) (594.24 KB - PDF)
What's new in pharmacovigilance - QPPV Update - Issue 1
English (EN) (609.89 KB - PDF)
News bulletin for pharmacovigilance programme update - Issue 6
News bulletin for pharmacovigilance programme update
English (EN) (456.55 KB - PDF)
News bulletin for pharmacovigilance programme update - Issue 5
English (EN) (514.54 KB - PDF)
News bulletin for pharmacovigilance programme update - Issue 4
English (EN) (657.06 KB - PDF)
News bulletin for pharmacovigilance programme update - Issue 3
English (EN) (488.45 KB - PDF)
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 – 3 May 2024
English (EN) (473.1 KB - PDF)
CTIS newsflash - 22 April 2024
English (EN) (288.05 KB - PDF)
CTIS newsflash - 5 April 2024
English (EN) (288.21 KB - PDF)
CTIS newsflash - 22 March 2024
English (EN) (283.88 KB - PDF)
CTIS newsflash - 8 March 2024
English (EN) (280 KB - PDF)
CTIS newsflash - 23 february 2024
English (EN) (287.63 KB - PDF)
CTIS newsflash - 9 February 2024
English (EN) (297.88 KB - PDF)
CTIS newsflash - 26 January 2024
English (EN) (283.79 KB - PDF)
CTIS newsflash – 12 January 2024
English (EN) (203.45 KB - PDF)
CTIS newsflash – 22 December 2023
English (EN) (775.65 KB - PDF)
CTIS newsflash - 8 December 2023
English (EN) (386.54 KB - PDF)
CTIS newsflash – 24 November 2023
English (EN) (546.85 KB - PDF)
CTIS newsflash – 10 November 2023
English (EN) (629.21 KB - PDF)
CTIS newsflash – 27 October 2023
English (EN) (587.53 KB - PDF)
CTIS newsflash – 13 October 2023
English (EN) (633.66 KB - PDF)
CTIS newsflash - 29 September 2023
English (EN) (573.26 KB - PDF)
CTIS newsflash - 15 September 2023
English (EN) (665.42 KB - PDF)
CTIS newsflash - 1 September 2023
English (EN) (455.49 KB - PDF)
CTIS newsflash – 18 August 2023
English (EN) (748.6 KB - PDF)
CTIS newsflash - 4 August 2023
English (EN) (575.83 KB - PDF)
CTIS newsflash - 21 July 2023
English (EN) (615.79 KB - PDF)
CTIS newsflash - 7 July 2023
English (EN) (866.26 KB - PDF)
CTIS newsflash – 23 June 2023
English (EN) (747.99 KB - PDF)
CTIS newsflash - 9 June 2023
English (EN) (698.43 KB - PDF)
CTIS newsflash - 26 May 2023
English (EN) (498.48 KB - PDF)
CTIS newsflash - 12 May 2023
English (EN) (438.13 KB - PDF)
CTIS newsflash - 5 May 2023
English (EN) (556.16 KB - PDF)
CTIS newsflash - 28 April 2023
English (EN) (478.03 KB - PDF)
CTIS newsflash - 21 April 2023
English (EN) (446.23 KB - PDF)
CTIS newsflash - 14 April 2023
English (EN) (486.34 KB - PDF)
CTIS newsflash – 31 March 2023
English (EN) (720.22 KB - PDF)
CTIS newsflash – 24 March 2023
English (EN) (648.83 KB - PDF)
CTIS newsflash – 17 March 2023
English (EN) (693.91 KB - PDF)
CTIS newsflash - 10 March 2023
English (EN) (446.06 KB - PDF)
CTIS newsflash - 3 March 2023
English (EN) (455.83 KB - PDF)
CTIS newsflash - 24 February 2023
English (EN) (450.06 KB - PDF)
CTIS newsflash - 17 February 2023
English (EN) (427.99 KB - PDF)
CTIS newsflash - 10 February 2023
English (EN) (494.95 KB - PDF)
CTIS newsflash - 3 February 2023
English (EN) (138.1 KB - PDF)
CTIS newsflash - 27 January 2023
English (EN) (135.5 KB - PDF)
CTIS newsflash – 20 January 2023
English (EN) (315.43 KB - PDF)
CTIS newsflash – 13 January 2023
English (EN) (130.75 KB - PDF)
CTIS newsflash - 6 January 2023
English (EN) (146.13 KB - PDF)
CTIS newsflash - 22 December 2022
English (EN) (117.45 KB - PDF)
CTIS newsflash - 12 December 2022
English (EN) (138.36 KB - PDF)
CTIS newsflash - 5 December 2022
English (EN) (146.31 KB - PDF)
CTIS newsflash - 22 April 2022
English (EN) (117.57 KB - PDF)
CTIS newsflash - 8 April 2022
English (EN) (120.71 KB - PDF)
CTIS newsflash - 1 April 2022
English (EN) (118.91 KB - PDF)
CTIS newsflash - 25 March 2022
English (EN) (134.03 KB - PDF)
CTIS newsflash - 18 March 2022
English (EN) (131.93 KB - PDF)
CTIS newsflash - 11 March 2022
English (EN) (138.49 KB - PDF)
CTIS newsflash - 4 March 2022
English (EN) (150.3 KB - PDF)
CTIS newsflash - 25 February 2022
English (EN) (123 KB - PDF)
CTIS newsflash - 18 February 2022
English (EN) (122.89 KB - PDF)
CTIS newsflash - 11 February 2022
English (EN) (117.93 KB - PDF)
CTIS newsflash - 4 February 2022
English (EN) (122.42 KB - PDF)
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
English (EN) (1023.34 KB - PDF)
Clinical Trials Highlights - February 2023
English (EN) (1.63 MB - PDF)
Clinical Trials Highlights - December 2022
English (EN) (1.15 MB - PDF)
Clinical Trials Highlights - October 2022
English (EN) (706.31 KB - PDF)
Clinical Trials Highlights - July 2022
English (EN) (864.72 KB - PDF)
Clinical Trials Highlights - May 2022
English (EN) (520.75 KB - PDF)
Clinical Trials Highlights - March 2022
English (EN) (546.63 KB - PDF)
Clinical Trials Information System (CTIS) highlights - January 2022
English (EN) (543.39 KB - PDF)
Clinical Trials Information System (CTIS) highlights - December 2021
English (EN) (677.31 KB - PDF)
Clinical Trials Information System (CTIS) highlights - October 2021
English (EN) (615.7 KB - PDF)
Clinical Trials Information System (CTIS) highlights - August 2021
English (EN) (521.49 KB - PDF)
Clinical Trials Information System (CTIS) highlights - June 2021
English (EN) (1.03 MB - PDF)
Clinical Trials Information System (CTIS) highlights - December 2020
English (EN) (979.81 KB - PDF)
Clinical Trials Information System (CTIS) highlights - June 2020
English (EN) (1.52 MB - PDF)
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
English (EN) (568.62 KB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 11
English (EN) (674.83 KB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 10
English (EN) (1.07 MB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 9
English (EN) (1.05 MB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 8
English (EN) (831.88 KB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 7
English (EN) (843.44 KB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 6
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)
Veterinary Medicinal Products Regulation highlights - Issue 5
English (EN) (1.02 MB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 4
English (EN) (1.2 MB - PDF)
Veterinary Medicinal Products Regulation highlights - Issue 3
English (EN) (865.91 KB - PDF)
Veterinary Medicines Regulation highlights - Issue 2
English (EN) (980.07 KB - PDF)
Veterinary Medicines Regulation highlights - Issue 1
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)
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
English (EN) (1.07 MB - PDF)
Big Data highlights - Issue 2
English (EN) (1.29 MB - PDF)
Big Data highlights - Issue 3
English (EN) (672.36 KB - PDF)
Big Data highlights - Issue 4
English (EN) (936.3 KB - PDF)
Big Data highlights - Issue 5
English (EN) (639.6 KB - PDF)
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
English (EN) (1.34 MB - PDF)
Electronic Application Form (eAF) newsletter - Issue 2
English (EN) (717.9 KB - PDF)
Digital Application Dataset Integration (DADI) newsletter - Issue 1
English (EN) (548.17 KB - PDF)
More information
Related documents
European Medicines Agency’s privacy statement for electronic newsletters
English (EN) (131.7 KB - PDF)