Regulatory covers the rules, approvals and market-access decisions that determine how medicines reach patients. It spans medicines and device regulation from the MHRA and EMA, health technology appraisals by NICE including the Highly Specialised Technologies (HST) programme for orphan and ultra-rare conditions, pricing and reimbursement, pharmacovigilance and post-marketing safety, and the compliance duties manufacturers and suppliers carry across the UK and Europe.
More than 100 animal studies suggest BPC-157 helps tendons heal, yet as of 2026 not a single controlled human trial has tested whether it works in people. A US advisory panel has voted to loosen access all the same.
By Tom Okafor, Clinical Trials Correspondent
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, signed into law in April 2025 and entering into force on 28 April 2026, represent the most substantial revision to the UK clinical trial regulatory framework since the original 2004 Regulations…
By Dr. Eleanor Vance, Regulatory Affairs Editor
For most licensed medicines that reach the NHS in England, the route to routine clinical use runs through the NICE single technology appraisal (STA) process: a structured assessment of clinical and cost-effectiveness that applies a cost-per-quality-adjusted-life-year (QALY)…
By Dr. Eleanor Vance, Regulatory Affairs Editor
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