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Focus on Regulation

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public consultation.

On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice.

The draft guideline provides the principles for the two step release and shipping of the investigational medicinal products by the qualified person and the trial sponsor. It also provides a description of the areas of interface between the manufacturer and the sponsor and required contractual agreements.

This draft guideline will complement the Delegated Regulation (EU) No 2017/1569 of 23 May 2017 on Good Manufacturing Practice for investigational medicinal products for human use and the detailed Commission guideline No C(2017) 8179 on Good Manufacturing Practice for investigational medicinal products for human use.

According to the draft guideline, investigational medicinal products should remain within the control of the sponsor until after the completion of the two step procedure. This two step procedure consists of batch certification by the Qualified Person and the regulatory release by the sponsor for use in a clinical trial. The draft guideline states that “both steps should be recorded and retained in the clinical trial master file held by, or on behalf of, the sponsor“.

The draft guideline further provides that regulatory release of the investigational medicinal product by the sponsor should verify that any aspects required for compliance with Clinical Trials Regulation (Regulation (EU) No 536/2014) are in place before investigational medicinal products are shipped to the clinical investigator sites. These checks will vary depending on the related clinical trial. They may, for example, include contracts with investigators and applicable service providers, any local and/or national approvals and if the authorisation of the clinical trial is subject to conditions, that these conditions are met.

With regard to the shipments of investigational medicinal products, the draft guideline provides that “it should be ensured that the shipping of investigational medicinal products minimises any risk while ensuring that the quality of the product is maintained and the applicable elements of guidelines on Good Distribution Practice of medicinal products for human use are taken into consideration“. The shipment of these products should be conducted according to the instructions given by, or on behalf of, the trial sponsor in the shipping order. The draft guideline also provides that temperature control and monitoring of the storage conditions are necessary and that related records should be maintained.

In addition, the draft guideline provides that any deviations from the specific conditions during the shipment of the products should be formally investigated. Responsibility for control of the shipment of investigational medicinal products remains with the trial sponsor or their representative until the product has been received and accepted by the clinical investigator site or pharmacy.

Finally the draft guideline discusses contractual arrangements between the manufacturer and the trial sponsor. The draft guideline provides examples of issues that should be addressed in these contractual arrangements.

Stakeholders are invited to submit their comments on this draft guideline before the 31st of August 2018. More information regarding the public consultation is available at this link.