The new tool is intended to help health technology developers determine whether a medicinal product falls within the EU’s Joint Clinical Assessment requirements before entering the formal HTA process.

The EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development.

The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry.

Healthcare organisations and technology developers face an expanding mix of state laws, sector-specific FDA expectations and federal policy initiatives rather than a single nationwide AI regulatory framework.

The guidance gives sponsors clearer recommendations for addressing trial design, safety monitoring, abuse potential and the operational challenges associated with hallucinogenic drug effects.

The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have announced a new formal collaboration initiative