TEDDY at CAT interested parties meeting: Revision of Guideline on safety and efficacy follow-up and risk management of ATMP and Guidelines on GCP specific to ATMPs

TEDDY at CAT interested parties meeting: Revision of Guideline on safety and efficacy follow-up and risk management of ATMP and Guidelines on GCP specific to ATMPs

On 13 September 2018, the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) organised a meeting with interested parties in order to discuss and get input on the ATMP (Advanced Therapy Medicinal Product) guidelines under development as well as on the comparability for ATMPs and the Commission – EMA action plan for ATMPs. Viviana Giannuzzi has been invited to participate in the meeting on behalf of TEDDY Network, where the following guidelines were discussed:

  • Guideline on safety and efficacy follow-up and RMP for ATMPs
  • Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
  • Guideline on quality, non-clinical and clinical aspects of investigational ATMPs

We asked Dr Giannuzzi why it was important to give voice to a paediatric organisation in the CAT meeting and in the overall discussion on ATMP use: “the paediatric issues are not dealt. Accordingly, in these guidelines the EMA and ICH paediatric provisions (e.g. ICH Topic E11, the 2007 EMEA Guideline on pharmacovigilance for medicines used by the paediatric population) are not mentioned and feedback from PDCO has not been requested so far. Given the increasing number of ATMPs tested and administered to children and the genetic nature of many paediatric diseases, these issues should be addressed”.

How can TEDDY Network contribute in the revision of these guidelines and which added value it can provide?  “This is a topic of interest for TEDDY that can provide a more specific contribution by providing the CAT with relevant comments on the ATMP guidelines on the paediatric specificities”.

The Committee for Advanced Therapies (CAT) is the EMA committee responsible for assessing the quality, safety and efficacy of ATMPs and following scientific developments in the field. The committee’s main responsibility is to prepare a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned. At the request of EMA’s Executive Director or the European Commission, the CAT can also draw up an opinion on any scientific matter relating to ATMPs as well as it participates in providing scientific recommendations on the classification of ATMPs.

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