News & Insights Search

A Council of Europe committee has warned that “an overly expansive interpretation” of the Medical Device Regulation (MDR) could undermine access to therapies based on human blood, tissues, and cells.

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the Centrally License Approving Authority (CLAA) framework.

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance of medical devices.

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.