Regulatory/GMP Compliance, Europe

EMA Commences Rolling Review of Remdesivir Data as COVID-19 Treatment

May 07, 2020

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

CHMP Recommends Suspension of All Ranitidine Medicines in the EU

May 06, 2020

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

Complying Confidently? Learning Lessons from Nitrosamine Impurities

May 02, 2020

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

Can EMA’s Regulatory Science Strategy Meet Medicine’s Major Challenges?

May 02, 2020

EMA’s strategy for regulatory science has divided opinion amongst various industry bodies.

Good Manufacturing Practices: Aseptic and Sterile Processing

May 02, 2020

Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.

EMA Endorses Statement Pledging to Fight COVID-19

April 30, 2020

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

EMA Sets Up COVID-19 Task Force

April 10, 2020

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

EMA Publishes COVID-19 Q&A Guidance

April 10, 2020

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

EMA Recommends Compassionate Use of Remdesivir for COVID-19

April 08, 2020

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

EMA Takes Measures to Ensure Supply of Medicines

April 08, 2020

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.