Latest from Eliza Slawther
Manufacturers should make use of joint scientific consultations under the EU Health Technology Assessment Regulation, but they must pay close attention to the selection criteria as consultation slots are limited, experts say.
The UK drug regulator says that men under the age of 55 years who are already taking valproate will not need to be reviewed by two specialists, as this measure is “unlikely to minimize risks” of neurodevelopmental disorders in children conceived by them any further.
The European Medicines Agency is looking for researchers to conduct scientific studies that address specific regulatory concerns, such as the development of innovative clinical trial designs or validation of novel manufacturing methods.
The European Commission has released three exercises to help pharma companies prepare for joint clinical assessments under the new EU Health Technology Assessment Regulation. Experts explain how manufacturers should interpret these and what their limitations are.
Company dossiers submitted for EU-level joint clinical assessments under the Health Technology Assessment Regulation will be made public. This could conflict with other strategic business decisions and should be planned for in advance, experts say.
Companies looking to conduct decentralized clinical trials in Europe can now easily see how Switzerland’s rules and processes compare with those of EU member states.