Expiry dating of investigational medicinal products

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Investigation of the incident showed no obvious errors in the trial.

The reaction of the subjects was “completely unexpected” and did not result from lack of quality or non-clinical data.

In March 2006, the company Te Genero sponsored a clinical trial conducted in healthy adults with a novel monoclonal antibody, (TGN1412) developed as an immunotherapeutic aimed at balancing the activity of human immune system.

During the first-in-human (FIH) study conducted at Northwick Park Hospital (UK), all six subjects exposed to the IMP (out of eight healthy male volunteers (two under Placebo)) experienced severe systemic adverse reactions, with multiple organ failure soon after intravenous administration of TGN1412.

Based on the ESG recommendations, EMA released a guideline in September 2007, aimed at assisting sponsors in 1) the transition from preclinical to early clinical development and 2) identification of risk factors to be considered when developing a new IMP.

However, important aspects linked to the complexity of biologics were not addressed in the guideline and it was difficult for sponsors of biological IMPs to gauge the appropriate level of details needed for each stage of development.

The drug dosage was administered per the protocol reviewed and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) and Multicenter Research Ethics Committee (MREC).

The incident was carefully investigated by an expert scientific group (ESG), set up by the Secretary of State for Health, charged with the responsibility to learn from the incident.

The IMPD is one of the core documents that compose the CTA.

The IMPD provides quality and non-clinical data on the IMP, in addition to data from previous clinical trials and human experience to evaluate the benefits and risks associated with the administration of an IMP during the conduct of the clinical trial.

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