The European Medicines Agency (EMA) on Wednesday opened for consultation a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs).
The guideline says investigational medicines should remain under the control of the sponsor until after completion of a two-step procedure, which consists of the batch certification by the Qualified Person (QP) and the regulatory release by the sponsor for use in a clinical trial.
“Both steps should be recorded and retained in the clinical trial master file held by, or on behalf of, the sponsor,” the six-page guideline says.
In terms of shipments, the guideline notes that shipping to a clinical investigator site or pharmacy should be conducted according to instructions given by, or on behalf of, the sponsor in the shipping order.
If necessary, temperature control and monitoring of the storage conditions should also be maintained, the guideline says.
“Deviations from the specified conditions during shipment should be formally investigated,” EMA adds, noting that the responsibility for the control of the investigational medicines shipment “remains with the sponsor (or representative) until it has been received and accepted by the clinical investigator site or pharmacy, where applicable.”
The guideline further discusses contractual arrangements, noting examples of what responsibilities should be taken into consideration.
“The regulatory release by the sponsor will also need to verify that any aspects required for compliance with the Regulation are in place before IMPs [investigational medicinal products] are shipped to the clinical investigator sites,” the guideline says. “These checks will vary depending on the trial, but may cover for example: Contracts with investigators and applicable service providers. If the authorisation of the clinical trial is subject to conditions, that these conditions are met. Any local/national approvals. Where applicable, de-coding arrangements are in place.”
Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice