Trial Supplies
Trial Planning Phase
The Trial Supplies station follows the Trial Documentation station and precedes the Pharmacovigilance station. Trial Supplies is a legal requirement and is specific for trials within the Clinical Trial Regulations scope. This station is part of the 'trial planning phase' group of stations.
Trial Supplies
To ensure all regulatory and governance requirements are met, sponsors and researchers should seek advice and support from individuals with specialised knowledge related to Investigational Medicinal Product supplies, such as a clinical trial pharmacist, clinical trials unit, or contract research organisation. Advice should be obtained early in the trial planning stage, as requirements may influence the trial’s design and any funding application.
The amended Clinical Trials Regulations specify requirements for investigational and non-investigational medicinal products, supporting a proportionate, risk-based approach to the manufacture, supply, and management of trial supplies.
Investigational Medicinal Product (IMPs)
IMPs used in trials must be manufactured, imported, and labelled in accordance with Good Manufacturing Practice (GMP), and the Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on GMP. In addition, the MHRA has published a blog with FAQs on the manufacture of IMP (including exemptions), as well as guidance on importing IMP, and separate guidance on the labelling of IMP used in clinical trials, which includes a flowchart to help determine the appropriate labelling requirement.
Non-Investigational Medicinal Products (NIMPs)
A NIMP is defined as: A medicinal product used in a clinical trial as described in the protocol, but not as an IMP. Examples include challenge agents, rescue medications, or background treatments. Sponsors are responsible for ensuring that NIMPs are appropriately sourced, authorised, and managed. The MHRA has published guidance on using NIMPs in clinical trials.
Pharmacy Set-Up: Pharmacy Assurance
The Health Research Authority (HRA) has introduced Pharmacy Assurance, which is a single technical review process for eligible studies across the UK. Further information can be found on the IRAS webpages. The process involves a single pharmacy technical review per study, used to streamline the pharmacy assessment carried out by each trial location.
Further Reading
- MHRA Guidance: Transitional arrangements for the manufacture and importation of IMP
- MHRA Guidance: Transitional arrangements for labelling of IMP
- MHRA (.PDF): Points to consider when preparing an IMP dossier.
- Pharmacy Assurance: Lettieri, M, et al, 2024. (.PDF)
- Clinical Trial Regulations: Countdown to Implementation: Video covering requirements for IMP at approximately the 32-minute mark