UK – NHS rolls out life-changing treatment offering ‘new hope’ for hundreds of children...
Hundreds of children with severe epilepsy will be able to benefit from a groundbreaking new treatment on the NHS that could significantly reduce their...
UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that...
Exceptions and modifications document – updates (01 Jan 2025)
-Overall updates were made to the document to reflect changes to UK legislation implementing new arrangements...
UK – Efanesoctocog alfa approved to prevent and treat bleeding in children and adults...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be used to treat...
UK – Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 February 2025, approved the medicine nemolizumab (brand name Nemluvio) for the treatment of...
UK – Access, new active substance and biosimilar work sharing initiatives
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong...
UK – Decision tree for navigating nanotechnology-based products for medical application
The decision tree above is to help support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical...
Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical...
This position paper reflects the current state of thinking of swissethics and Swissmedic on
decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their
respective...
Europe – Guideline on assessment and reporting of mechanistic models used in the context...
Mechanistic models, i.e. mathematical or computer models that integrate biopharmaceutical, physico mechanical, (patho)physiological and pharmacological processes, along with population characteristics, are frequently and increasingly...
Europe – Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal...
The guideline provides guidance on the structure and data requirements for a clinical trial application for investigational ATMPs and a perspective towards Marketing Authorisation...
UK – MHRA drafts mRNA cancer immunotherapy guidance
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer...
