Pharmaceutical News and Updates
MHRA launches pilot programme to incentivise low-risk Phase I clinical trials in healthy adult volunteers
Overview The UK’s MHRA has launched a pilot programme to significantly speed up the approval of certain low-risk Phase 1 clinical trials in healthy adult volunteers. The goal is to reduce the first-cycle MHRA review…
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…
EMA PIP Reference numbers
Historically (and still referenced in many older documents and systems like EudraCT), the final EMA decision on a Paediatric Investigation Plan (PIP) was commonly identified by a short “P reference number” in the format P/xxx/yyyy…
Medicines for Human Use (Clinical Trials Amendment) Regulations 2025 coming into full effect on 28 April 2026
The UK’s clinical trials framework is set for a major update with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 coming into full effect on 28 April 2026. This represents the most significant…
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…
The Cost-Effectiveness of Pharma Design Limited: A Practical Alternative to Traditional CROs for European Regulatory Support
In the competitive landscape of pharmaceutical development, regulatory affairs play a pivotal role in bringing innovative therapies to market. For developers, particularly those based outside Europe, navigating the complexities of EU and UK regulations can…