Regulatory Oversight

Harmonization of global regulations fosters innovation and ensures quality medicines.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Revolutionary therapies restructure pharmaceutical manufacturing.

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

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.