15/16 December 2020
In their 2018 Work Plan the European Medicines Agency (EMA) Committee for Advanced Therapies (CAT) announced a guideline on quality, non-clinical and where applicable clinical requirements for applications for clinical trials for ATMPs. Just recently, in the beginning of August, this "Draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products" was issued. It was developed together with the European Commission (EC) and the expert group of the competent authorities of the Member States
As stated on the website "The Guidelines will adapt good clinical practice requirements ("GCPs") to ATMPs. It will be a document that focuses on ATMP specificities only and which applies in addition to the GCP Guidelines of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)." Stakeholders are invited to comment the draft guideline until 31 October 2018. Comments should be sent preferably to sante-pharmaceuticals-B5@ec.europa.eu.
The heterogeneous and complex nature and character of ATMP requires in some cases more flexibility in regulatory requirements as classic medicinal products. This was shown with adoption of the GMP for ATMP guideline and the release of the Draft Guideline on Safety and Efficacy Follow-up and Risk Management of ATMPs". The biological origin, short shelf-life or long term effects of the products as well as the manufacturing conditions additionally entail specific challenges to the design and conduct of the clinical trials. Therefore the draft guideline explains: "While the general principles of GCP 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 to subjects after end of the clinical trial)."
For more details, related documents and commenting please also read the complete Draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products on the European Commission website.