HTA
What is Health Technology Assessment? A Guide for Biotechs
For biotech companies developing innovative therapies, regulatory approval is only the first major hurdle. Once a medicine receives marketing authorisation, the real question for patients and healthcare systems becomes: Will it be reimbursed and made…
PICO Framework Explained for HTA Submissions: A Practical Guide
For Pharma/Biotech companies advancing innovative therapies toward European markets, understanding the PICO framework is central to successful Health Technology Assessment (HTA) submissions. Under the EU Health Technology Assessment Regulation (HTAR), the Joint Clinical Assessment (JCA)…
Aligning Regulatory Authorisation and Health Technology Assessment in Europe
US biotechnology companies developing innovative medicines increasingly target the European market for regulatory approval and subsequent patient access. In both the European Union (EU) and the United Kingdom (UK), recent procedural reforms have introduced requirements…
The MHRA-NICE Accelerated Aligned Pathway Pilot.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched the Accelerated Aligned Pathway pilot, a groundbreaking initiative designed to streamline the regulatory and health…