Regulatory/GMP Compliance, Europe

EMA Starts Review of Dexamethasone as COVID-19 Treatment

July 30, 2020

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.

EC Grants Marketing Authorization for Remsima

July 29, 2020

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

July 23, 2020

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

EMA Issues Final Opinion on Nitrosamines

July 16, 2020

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

Regulatory Authorities have Published a Report on COVID Vaccine Development

July 16, 2020

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Performing Remote Audits During the Pandemic

July 01, 2020

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Emer Cooke Receives Nomination for Position of EMA Executive Director

June 25, 2020

Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.

CHMP Recommends EU Authorization of Remdesivir for COVID-19

June 25, 2020

The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.

EU and US Discuss Regulatory Collaboration

June 23, 2020

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.

EMA Publishes 2019 Annual Report

June 16, 2020

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