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:
2. Pharmacovigilance activities:
3. Other specialised areas and activities
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".