Revision of Classification of Advanced Therapy Medicinal Products

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

In 2012, the European Medicines Agency (EMA) published a reflection paper on the classification of ATMP (see our GMP News from 14. August 2012). This classification is supposed to help developers to identify the applicable regulatory framework and furthermore the development path and the scientific-regulatory guidance to be followed. Amongst this, it will be helpful in the dialogue with the regulators and to determine whether - depending on the type of product - a liaison with other committees such as the Committee for Orphan Medicinal Products (COMP) and/or Paediatric Committee (PDCO) may be recommended to the applicant.

Now, on 30 June, they published a revision of this document, a draft reflection paper on classification of advanced-therapy medicinal products open for public consultation until 31 October 2014. The aim of this reflection paper is to provide guidance on the ATMP classification procedure, as well as on the interpretation of key concepts of the definition of gene therapy medicinal product, somatic cell therapy medicinal product, tissue engineered product, and combined advanced therapy medicinal product. The guidance reflects the experience gained in the application of the classification procedure.

Comments on the paper should be send to advancedtherapies@ema.europa.eu