Commission guidelines on Good Clinical Practice specific to ATMPs

On 10 October 2019, the European Commission published some guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products

The 15-page document lists the Commission’s guidelines on several topics regarding the research and development of ATMPs including clinical trial design, non-clinical studies, quality and safety instructions, traceability, and sample retention.

When it comes to medical devices, the guidelines specify that if an ATMP incorporates a medical device (“combined ATMP” and medical devices that are otherwise an integral part of the investigational ATMP), the Investigators Medicinal Product Dossier (IMPD) should contain:

  • information on the characteristics, performance and intended use of the device; and
  • information whether the medical device part(s) comply with the relevant general safety and performance requirements provided for under the new Medical Devices Regulation. When this is not the case (e.g. the medical devices used in an investigational combined ATMP are in an investigational phase as well), a justification should be provided as to the suitability of the medical device for the intended use, having due consideration to the relevant general safety and performance requirements.

Where applicable, the cover letter should contain a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use. In addition, the Protocol should contain summary information on the characteristics, performance, intended use of the device and its regulatory status.

The full document can be found here

Date: 08/11/2019 | Tag: | News: 1011 of 1574
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