Quality/GMPs

Cheryl Barton is director of PharmaVision, 

Articles

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.

EMA Extends OPEN Framework to More Medicines

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

EU Takes Steps to Prevent Antibiotic Shortages Next Winter

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk

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

EMA Issues Drug Safety Reminders

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

EMA Guidance Looks to Prevent Drug Shortages

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

EMA Publishes Annual Report for 2022

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

Regulatory/GMP Compliance, Europe