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India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.

The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.

The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on its plans to publish good manufacturing practice (GMP) certificates and inspection outcomes.

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.

Planned changes to the Medical Device Regulation (MDR) would impose “invalid and unenforceable” fee requirements on notified bodies, according to a legal opinion shared by Team-NB.