Regulatory/GMP Compliance, Europe

EMA Issues Drug Safety Reminders

May 17, 2023

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

EMA Guidance Looks to Prevent Drug Shortages

May 17, 2023

The agency has published guidance on good practices for securing the supply of medicines.

EMA Publishes Annual Report for 2022

May 17, 2023

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

EC Authorizes Fabry Disease Treatment

May 11, 2023

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

Europe Lifts COVID-19 Business Continuity Status

May 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

Optimizing the Manufacture of Emerging Therapies

May 02, 2023

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Changes Afoot in Pharmaceutical Laws and Regulations in Spain

April 02, 2023

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

How Banning Titanium Dioxide Might Impact Pharma

March 15, 2023

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

EMA Guidance on Paediatric Investigation Plans

March 02, 2023

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Convergence in the Global Regulatory Village

February 03, 2023

Harmonization of global regulations fosters innovation and ensures quality medicines.