EMA guideline on investigational medicinal products for public consultation

EMA guideline on investigational medicinal products for public consultation

The European Medicines Agency (EMA) has issued a draft guideline, which lays down the principles for management of the IMP (investigational medicinal products) by the sponsor for use in a clinical trial in accordance with GCP and GMP.

The guideline is currently available for public consultation until 31.Aug.2018. The comments should be provided using EMA template and all completed comments should be sent to ADM-GMDP@ema.europa.eu.

Here are some highlights from the guideline:

Two-step release procedure:

The IMP should remain under the control of the sponsor until after completion of the two-step procedure. I.e. the IMPs must not be shipped to the site before following releases are obtained:

    1. QP release (batch certification)
    2. Regulatory release

Regulatory release includes for example the site has obtained all applicable approvals, contracts and decoding procedure (for blinded trials) in place.

Shipping of IMP

  • Shipping to sites should be conducted according to instructions given by the sponsor.
  • Records including timing to support the supply chain should be maintained.
  • Unless the IMP does not require any special storage conditions, temperature control and monitoring of the storage conditions are necessary and these records should also be maintained.
  • Temperature deviations during shipment should be formally investigated.
  • Responsibility for the control of the IMPs shipment remains with the sponsor (or representative) until it has been received and accepted by the site.
  • A detailed inventory of the shipments should be maintained.

Transfers of IMPs from one trial site to another should remain the exception. Such transfers should be covered by standard operating procedures and QP advice should be sought.

Contractual arrangement:

Responsibilities of the manufacturer and sponsor should be appropriately defined, agreed and controlled in a written contract addressing such as relabeling, sourcing, recall, decoding, storage, handling of temperature deviations during shipment, return, destruction, access to documentation for TMF.

Ensure that the most up to date information is provided to the QP for consideration during thebatch certification process in accordance with the documents set out in the clinical trial applications.

Reference to EMA guideline:


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