The following terminology will be introduced into the clinical trials regulations:
Non-investigational medicinal product
A non-investigational medicinal product is a medicinal product that will be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product.
For further guidance on what would qualify as a non-investigational medicinal product, read the Medicines and Healthcare products Regulatory Agency (MHRA) guidance.
Notifiable trial
A notifiable trial is a trial with no significant safety concerns relating to any of the investigational medicinal products (IMPs), as far as the sponsor is aware having made reasonable enquiries.
The full definition for a notifiable trial, and the conditions that a notifiable trial must meet, is set out in regulation 11A of the The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
The MHRA will give automatic authorisation to any notifiable trials submitted to them, after they have reviewed the submission and confirmed it meets the eligibility criteria for being considered a notifiable trial.
A trial being categorised as notifiable will not alter other regulatory reviews, meaning that if needed it would still need to undergo Research Ethics Committee (REC) review and any other regulatory reviews, for example Administration of Radioactive Substances Advisory Committee (ARSAC).
For further information on what would be considered a notifiable trial, how notifiable trial applications will be submitted, and how the MHRA will process them, read the MHRA's guidance on notifiable trials.
Public registry
A public registry will be defined as a primary or partner registry of, or a data provider to, the World Health Organization International Clinical Trials Registry Platform, provided that the registry, or the data provider, facilitates public access to information about the trial in the United Kingdom.