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Draft Guideline for Handling and Shipping Investigational Medicines proposed by EMA opened for public consultation

Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).

The European Medicines Agency (EMA) has opened for public consultation the draft 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). According to the draft guideline:

1) 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 and both the steps should be recorded and retained in the clinical trial master file held by, or on behalf of, the sponsor.

2) 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.

3) Temperature control and monitoring of the storage conditions should also be maintained if required

4) Deviations from the specified conditions during shipment should be formally investigated keeping in mind 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."

5) Contracts with investigators and applicable service providers should be in place stating the responsibilities to be taken into consideration.

6) 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 such as decoding procedures, local and national approvals, meeting conditions of the authorization of clinical trial subjects etc.