Open consultations
date: 13/09/2023
- On the ICH reflection paper on proposed international harmonisation of real-world evidence (RWE) terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines, until 30 September 2023.
- On the draft reflection paper outlining considerations on single-arm trials that are submitted as pivotal evidence for establishing efficacy in marketing authorisation applications, until 30 September 2023.
- On the draft reflection paper on the use of artificial intelligence (AI) to support the safe and effective development, use and regulation of human and veterinary medicines, until 31 December 2023.