Regulatory Oversight

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Analytical methods and tools play a pivotal role in cleaning validation.

The EHDS aims to increase access to health data, but how will it impact pharma?

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

What does the 2024 VPAS mean for pharma?

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

The EC is calling for interested parties for their safety and orphan drug committees.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.