EMA

First two CAR-T cell medicines recommended for approval in the European Union

The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are advanced therapies for blood cancer. They belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients' own immune cells to treat their cancer.

Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee

The European Commission has launched a call for expressions of interest for civil society representatives to join the Management Board of the European Medicines Agency (EMA), as well as the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). This is an opportunity for civil society representatives to participate in EMA’s activities.

Towards more ethical use of animals in medicine testing

The European Medicines Agency (EMA) has published today its first report summarising the Agency's actions carried out by two of its committees in 2016 and 2017 - the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) - to support the implementation of the so-called 3Rs principles for more ethical use of animals in medicine testing across the European Union (EU).

Call for patient organisation representatives to join the Committee for Orphan Medicines

The European Commission’s Directorate-General for Health and Food Safety has launched a call for expressions of interest to represent patient organisations in the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). The call aims to fill three positions for COMP members nominated by the European Commission to represent patient organisations.

EMA to relocate to Amsterdam, the Netherlands

The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken by the EU 27 Member States in the margins of the General Affairs Council (Art. 50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.

EU-US mutual recognition of inspections of medicines manufacturers enters operational phase

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other's inspection outcomes and hence for better use of inspection expertise and resources.

New action plan to foster development of advanced therapies

The European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) have published a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers.

EMA

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