EMA Committee for Advanced Therapies (CAT) publishes 2018 Work Plan

End of 2017, the EMA Committee for Advanced Therapies (CAT) has published their work plan for 2018. It includes activities on pre-authorisation, on pharmacovigilance and on other topics like scientific and regulatory considerations on gene editing technologies and for adeno-associated viral (AAV) vector based GTMPs. Relating to the fact that the UK will leave the EU and a relocation of the Agency will become necessary, the CAT stated: "The activities outlined in the work plan for 2018 have been agreed considering the respective business priorities, as well as the Agency’s relocation as a result of the UK’s exit from the EU and its impact on the Agency’s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency". It remains to be seen whether the "Brexit" will influence the work and activities more or less.

In detail the agenda of the current work plan incudes:

1.Pre-authorisation activities:

• Revision of the "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells"
• Development of a guideline on quality, non-clinical and where applicable clinical requirements for applications for clinical trials for ATMPs.
• Development of a Questions and Answers document on comparability for ATMPs

2. Pharmacovigilance activities:

• Reflection on the use of Registry data for the post-authorisation follow-up of ATMPs - Development of minimum requirements for registries for CAR-T cells.

3. Other specialised areas and activities

• Reflection on the regulatory status of medicines based on, or produced by means of gene editing technologies
• Consideration of the scientific requirements of medicines based on, or produced by means of gene editing technologies
• Consideration of the scientific requirements of gene therapy medicinal products based on adeno-associated viral (AAV) vectors.
• Addressing the Environmental Risk assessment of ATMPs containing genetically modified organisms (GMO) / genetically modified micro-organisms (GMM).

Additionally, the work plan informs about the participants of the working committees of the listed topic and who will be the CAT topic leader. For more detailed information, please read the "CAT work plan 2018".