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Researchers from the European Medicines Agency (EMA) have published a paper on regulatory research priorities for AI across the medicine lifecycle.

The Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on using a weight of evidence (WOE) approach to assessing the toxicity of monoclonal antibodies in Japan.

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.

The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.

A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.

Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.

The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).