Quality/GMPs

Articles

The agency is evaluating risks associated with the painkiller metamizole. It is also reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines. 

EMA Reviews Risks Associated with Painkillers and CAR T-Cell Medicines

The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.

European Commission Approves Tislelizumab for Non-Small Cell Lung Cancer

The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.

EMA Expands Real-World Data Capacity

Chris Spivey is the editorial director of 

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

EMA Recommends New ALS Treatment

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Europa Perspectives: Helping to Navigate the Regualtory System

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

EMA and HMA Launch Real-Word Data Catalogues

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

Europa Perspectives—Pan-European Challenges and Solutions Post Brexit

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

EMA Given Grant to Support Establishment of African Medicines Agency

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

Regulatory/GMP Compliance, Europe