The European Commission launched on 1 August 2018 a targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice (GCP) for Advanced Therapy Medicinal Products (ATMP).
Article 4 of Regulation (EC) No 1394/2007 (the ATMP Regulation) requires the European Commission, after consulting the European Medicines Agency (EMA) to draw up detailed guidelines on GCP specific to ATMPs. As a result, the Commission has recently launched a consultation and published a corresponding consultation document outlining the proposed guidelines on GCP. The guidelines include chapters on the scope, general principles, clinical trial design, application dossier, the quality of investigational ATMPs, administration procedures, traceability, retention of samples, protection of clinical trial subjects, safety reporting, and monitoring.
The stakeholders targeted for this consultation include: small and medium-sized enterprises, academia, hospitals and patient organisations.
Although the Commission has reaffirmed its commitment to supporting the development of advanced therapies, and a number of shortcomings have been identified (e.g. lack of sustainable funding, lack of transparency and regulatory guidance) no revision of the ATMP Regulation, which was adopted in 2007, is foreseen at this stage. Instead, the Commission has decided to update the ATMP guidelines. To this end, on 1 June 2018, the European Commission published a revised action plan on ATMPs. One of the planned actions included in the plan was the finalisation of GCP for ATMPs “to address as appropriate any specific needs to ATMP developers”.
For ESMO it is of importance that (clinical) development of ATMPs are subject to proper regulatory guidance to promote innovation and transparency to ensure access to treatment for patients with (rare) cancers. The current discussion on ATMPs have included several rare cancers, including cell-based cancer immunotherapy.
Stakeholders can submit their response by 31 October 2018 at the latest. Responses should be send to sante-pharmaceuticals-B5@ec.europa.eu.