Quality Systems

Articles

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

EMA and HMA Publish Network Strategy for Public Consultation

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan. 

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

Cheryl Barton is director of PharmaVision, 

Regulators, EMA and HMA, have published principles and recommendations 
on the use of LLMs, which are being increasingly used for daily tasks.


Responding to the Increased Use of Generative AI

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Suspends Sickle Cell Disease Medicine

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

EMA Gives Approval to Several Cancer Treatments

What impact will the AI Act have on pharma and digital medicine?

European Artificial Intelligence Act Comes into Force

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Germany Amends and Approves the New Medical Research Act

Innovative solutions are making personalized cell and gene therapies accessible to all.

Frontrunners in Automated Cell and Gene Therapy Manufacturing

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

EMA’s PRAC Offers Recommendations for Glucagon-like Peptide-1 Receptor Agonists and Glatiramer Acetate

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

Regulatory/GMP Compliance, Europe