Compliance

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

This brings the total number of notified bodies appointed under the IVDR to 14

As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.

The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.

Recent court cases initiated by the Swiss medicines regulator against “unbalanced” media reporting on GLP-1 drugs for weight loss highlights its zero tolerance for any form of misinformation that compromises patient safety.

The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

Measures for reporting interruption of supply or discontinuation of devices in Europe were rushed into the Medical Device Regulation, a German law firm claims, leading to the need for a stricter interpretation.