News from the EMA - Volume 32, Issue

This section offers a selection from recent news items from the EMA. Medical Writing. 2023;32(2)86–91.

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

News from the EMA - Volume 31, Issue

The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Anuradha Alahari (editor)

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

News from the EMA - Volume 32, Issue

This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…

News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor)   EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

News from the EMA - Volume 31, Issue

News from the EMA - Volume 31, Issue

Medical Writing. 2022;31(4)65-69. Section editor: Anuradha Alahari

News from the EMA - Volume 32, Issue

Section Editor: Anuradha Alahari Medical Writing. 2023;32(4):64–68. https://doi.org/10.56012/oknc4756