How should advanced therapies be classified?

Emerging uses of EMA Approved Drugs – by Gary Finnegan – The EMA has launched a public consultation on the classification of advanced therapies.

The Agency has published a reflection paper on the issue, setting out the legal basis for categorising medicines as advanced therapies and detailing the criteria for grouping new drugs as gene therapies, somatic-cell therapy, tissue-engineered medicines and combined medicines.

The paper also outlines the kinds of information applicants should provide when applying to have a medicine classified as an advanced therapy and it provides examples of borderline cases where scientific knowledge may be limited or evolving rapidly.

Advanced therapies are medicines that are made from genes and cells and may offer groundbreaking new treatment opportunities for many diseases and injuries.

As part of its role, the Agency’s Committee for Advanced Therapies (CAT) issues opinions on whether a medicine can be classified as an advanced therapy, and can therefore be assessed for a European Union-wide marketing authorisation via the European Medicines Agency.

Separately the EMA has launched a new e-learning course on the submission of medicines. The module will help to train industry executives on how to submit information to the agency in accordance with new EU pharmacovigilance legislation.

The modules are free to access and can be streamed live or downloaded. On completion of the e-learning course, participants are able to take a knowledge evaluation test. The Agency says that at least one user from each marketing-authorisation holder should be complete the course.