Switzerland – Swissmedic mandates nitrosamine risk assessments in some applications
The Swiss Agency for Therapeutic Products (Swissmedic) has updated guidance on nitrosamines to clarify when new authorization applications must include a risk assessment.
Swissmedic added...
Europe – Successful pilot paves the way for implementation of ePI
The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot...
Europe – A common EU approach to data transparency in medicine regulation
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and...
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...
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...
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...
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...
Europe – First treatment against severe thyroid eye disease
EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye...
Europe – New treatment against Duchenne muscular dystrophy
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients...
UK – MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 April, approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over,...
