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…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October  16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

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)…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

News from the EMA - Volume 27, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from October 2017 to December 2017. More information can be found on the Agency’s website: http://www.ema.europa.eu/

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

News from the EMA - Volume 33, Issue

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

News from the EMA - Volume 33, Issue

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