Quality Systems

Articles

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

EMA Recommends Seven Medicines for Approval

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

GenSight Biologics Submits Application to Market Lumevoq in the EU

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC

Vanessa Fachada Oliveira, is a pharmacovigilance manager and EU QPPV at Arriello. She is a qualified pharmacist with knowledge of pharmacovigilance (PV) legislation, and extensive experience in PV, Quality Management and Medical Information. Based in Lisbon, Portugal, Vanessa supports clients both as a PV consulting specialist and as a global EU QPPV/deputy QPPV or LPPV for the local territory. Arriello is a global provider of regulatory affairs and pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

Pharmacovigilance Under Scrutiny: Why Companies are Falling Short

Sean Milmo is a freelance writer based in Essex, UK.

The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.

Regulations Under Regular Review

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

EMA Evaluating COVID-19 Treatment

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

MHRA to Resume On-Site Inspections in September 2020

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites

EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.

Tackling Serious Impurities

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

Regulatory/GMP Compliance, Europe