Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)

On 10 October 2019 European Commission issued the guidelines on GCP specific to clinical trials conducted with ATMPs

ATMPs are complex and innovative products that may pose specific challenges to the design and conduct of clinical trials. For example, manufacturing constraints and the short shelf-life of the product may require the implementation of tight controls on logistical arrangements to administer the product. Likewise, the mode of application may render very difficult the use of placebo controls and/or may require specific training. Additionally, the long-term effects of the product may require specific arrangements for long-term follow-up of the subjects. Moreover, it is recognized that it may not always be feasible to generate relevant non-clinical data before the product is tested in humans.

While the general principles of GCP set out in ICH Guidelines are applicable to clinical trials with ATMPs, in some cases, it may be necessary to adapt those to the specific characteristics of ATMPs (e.g. regarding retention of samples). The implementation of additional measures may also be necessary (e.g. traceability requirements for ATMPs that contain cells or tissues of human origin, follow-up of patients after end of the clinical trial, training on upstream intervention of subjects and/or administration procedures).

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