CAT monthly report of application procedures, guidelines and related documents on advanced therapies

The Committee for Advanced Therapies (CAT) held its 102nd CAT meeting on 14 – 16 March 2018.

The CAT Monthly Report includes statistical data on CAT scientific recommendations on Advanced Therapy Medicinal Product (ATMP) classification, certifications, initial evaluations, CAT contributions to Scientific Advice and Paediatric Investigation Plans, as well as variations, line extensions, renewals. Scientific recommendation on advanced therapy product classification Further to consultation with the European Commission, the CAT finalised 1 scientific recommendation on the classification of advanced therapy medicinal products.

The following product was classified as a tissue engineered product:

• Autologous expanded auricular chondrocytes, intended for surgical implantation for the repair of microtia. Organisational matters

• CAT adopted the public report on the expert meeting on adeno-associated viral vector-based gene therapy medicinal product, which was held at the EMA on 6 September 2017. The report will be published shortly.

• CAT adopted the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. The guideline, which is a revision of the guideline on genetically modified cells published in April 2012, will be released for public consultation by June 2018.

• CAT discussed the programme of the joint CHMP/PDCO/CAT Strategic Review and Learning meeting that will take place in Oslo, Norway on 7 – 9 May 2018 under the auspices of the Bulgarian presidency of the European Union.