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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer...
Europe – Clinical Trials Regulation becomes fully applicable
From today, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed...
UK – NICE approves Vertex’s Casgevy one-time gene therapy for sickle cell disease
NICE’s final draft guidance states that the one-time treatment will be made available on the NHS in England under a managed access scheme for...
Europe – European Shortages Monitoring Platform fully operational for monitoring of shortages in the...
The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national competent authorities (NCAs) to...
Europe – New combination of medicines to treat parasitic worm infections
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm...
Europe – European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of...
