The European Medicines Agency (EMA) has invited public consultation and feedback on changes to the existing guideline on the evaluation of anticancer medicinal products in man. The EMA defines a ‘guideline’ as “A document providing guidance on the scientific or regulatory aspects of the development of medicines.”

The upcoming revision (revision 6) proposes a review of the concepts related to biomarkers, which are increasingly used to define malignant diseases and develop new treatment strategies, alongside other more minor amendments.

The concept paper for revision 6 states:

“Since the adoption of the guideline, the use of biomarkers in oncology and haematology has evolved and progressed considerably. This has resulted in novel development strategies as well as new definitions of therapeutic indications based on biomarkers. The current guidance does not adequately address these new aspects.”

Review the suggested changes and send your feedback to the EMA

The EMA invites you to read the concept paper, which describes the proposed changes to the guideline. You can read the draft paper by clicking here.

You can provide comments using this template and send it to by the deadline of 14 April 2019.