The European Commission recently published the Guidelines for Good Clinical Practice (GCP) specific to advanced therapy medicinal products (ATMPS) covering gene therapies, cell therapies and tissues engineered products.
Regulation (EC) No 1394/2007 (ATMP Regulation) necessitates that the European Commission adopt the GCP Guidelines specific to ATMPs (Guidelines). The European Medicines Agency (EMA) provides technical inputs. Thereafter a period of public review and comment commenced in 2018. ATMPs are complex in nature and offer operational, clinical and regulatory challenges in regard to GCP compliance.
The Guidelines require that all clinical trials sponsors comply with GCP in Europe. GCP requirements were developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)—any clinical trials utilizing ATMPs must adhere to ICH.
The Guidelines were authored to focus on areas of GCP compliance necessitating an understanding of the specificities of ATMPs. These include:
- Particular manufacturing constraints and short shelf-life of specific ATMPs
- Specific mode of administration and the need for related training of the clinical trial as well as challenges of placebo usage
- Long-term patient follow up requirements to monitor ATMPs effects
- Sample retention
- Traceability of ATMPs containing human-originated cells or tissues
- Practical challenges concerning blinding of the investigator, the site team or the patients
- Considerations involving the generation of relevant non-clinical data prior to clinical trial conduct
Other key issues addressed include patient population selection, protocol design, pre-existing non-clinical data requirements, ATMPs manufacturing, safety reporting, samples retention and use of medical devices.
Follow the link to read the read the guidelines in their entirety.