Quality Systems

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The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

EMA Publishes 2019 Annual Report

Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

EMA Validates MAA for Leo Pharma’s Tralokinumab

The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.

EC Grants Marketing Authorization for Subcutaneous Formulation of Daratumumab

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

The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.

A Strategic Shake Up in Europe’s Medicines Sector

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

EMA Validates Marketing Authorization Application for Tafasitamab

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

HPRA Grants IMP License to Wasdell Group

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

International Coordination on COVID-19 Treatments Necessary, Says EMA

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

International Regulators Work to Coordinate Pandemic Response

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic. 

EU Member States Meet to Discuss Drug Shortages During COVID-19

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

Regulatory/GMP Compliance, Europe