ATMP

Subscribe to ATMP via RSS

On 16 October 2019, the European Commission published the Guidelines for Good Clinical Practice (GCP) specific to advanced therapy medicinal products (ATMPS) covering gene therapies, cell therapies and tissue engineered products. These Guidelines are available at the website of the European Commission.

Background

The European Commission was legally required to adopt the GCP Guidelines specific to ATMPs (the Guidelines) by Regulation (EC) No 1394/2007 (ATMP Regulation) with the technical input from the European Medicines Agency (EMA). The Guidelines were adopted after a period of public consultation with the targeted stakeholder consultation in the second half of 2018.

The Guidelines reflect the experience gained by the European Commission and the EMA in the field of ATMPs and in the assessment and authorisation of this type of medicinal products. Due to their complex nature, ATMPs present specific practical operational and regulatory challenges related to GCP compliance.Continue Reading Latest Updates on Good Clinical Practice for Advanced Therapies in the EU

On 22 November 2017, the European Commission adopted new guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). ATMP manufacturers must ensure compliance with these guidelines no later than 22 May 2018.

The guidelines seek to reflect the rapid technological and medical advancements being made in the field of ATMPs (i.e. gene therapies, somatic cell therapies and tissue engineered products), such as decentralised manufacturing for autologous products, automated production, outsourced reconstitution, and gene editing technologies such as CRISPR and immunomodulators. Currently, these new technologies must comply with the general GMP guidelines set out in Volume 4 of The rules governing medicinal products in the European Union. However, these products are often developed in an academic or hospital setting under quality systems different to those typically required for the manufacture of conventional medicinal products.

Continue Reading New guidelines on GMP for Advanced Therapy Medicinal Products