The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA.
In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines," the agency said in a statement.
Reflection paper on classification of advanced therapy medicinal products, released 30 April, clarifies the ATMP classification procedure, which is used by EMA and the European Commission to clarify the status of a product before being reviewed by the Committee for Advanced Therapies (CAT).
"The ATMP classification is based on the evaluation of whether a given product fulfils one of the definitions of gene therapy medicinal product (GTMP), somatic cell therapy medicinal product (sCTMP) or tissue engineered product (TEP) and whether the product fulfils the definition of a combined ATMP or not," explains EMA in the reflection paper. "However, it is also acknowledged that, due to the complex nature of these therapeutic products, the limited data package at an early stage of product development and the rapid evolution of science and technology, questions of borderline may arise."
The use of a voluntary ATMP classification procedure, writes EMA, should assist sponsors of ATMP products to clarify-particularly in these borderline cases-the applicable regulatory framework in a free, non-legally binding way to both save money and interface with EMA and its associated committees.
The paper comes just two weeks after EMA released another reflection paper, Reflection Paper on Clinical Aspects Related to Tissue Engineered Products, which expands upon therapeutic claims, pharmacodynamics, pharmacokinetics, efficacy endpoints, trial duration, concomitant treatments and safety issues related to ATMPs.
EMA - Reflection paper on classification of advanced-therapy medicinal products
EMA - Statement: Reflection paper on classification of advanced therapies released for public consultation