Quality/GMPs

Articles

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

Europe Publishes Electronic Product Information for Selected Medicines

The EC is calling for interested parties for their safety and orphan drug committees.

European Commission Searches for Committee Experts

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

EMA Creates Mechanism for Support during Drug Shortages

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

Sterling Pharma Acquires NewChem Technologies

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.  

EMA Recommends Multiple Myeloma Treatment

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

EMA Recommends Seven Medicines for Approval in October

Editor of Pharmaceutical Technology Europe

Janssen Seeks European Approval of Extended Indication for Rybrevant

Cheryl Barton is director of PharmaVision, 

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Phasing Out COVID-19 Regulatory Flexibilities

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility 

The framework is now expanded beyond COVID-19 vaccines and treatments.

Regulatory/GMP Compliance, Europe