Roman is a Medical Affairs’ expert and a consultant in the Life Sciences Division at ALTEN. In the following article, he explains everything about innovative medicines and the advanced therapy medicinal products.
What are the advanced therapy medicinal products?
They are medicines for human use based on genes, cells or tissues. These are at the forefront of innovation, and give new opportunities to face the variety of diseases that have limited or no therapeutic options.
How can we classify them?
These kinds of medicines can be sort in four main groups:
- Generic therapy medicines.
- Medications to treat somatic cells.
- Tissue engineering products (TEP).
- Combined advanced therapy medicinal products.
Are there regulatory and legislative concepts that can be applied to these medicines?
Advanced therapy medicinal products must be controlled by a normative regulation. This is in order to safeguard public health because of their complexity.
The Committee of Advanced Therapy (CAT) of the European Medicines Agency assesses the quality, the security and the efficiency of the advanced therapy medicines. As it is said in the Annex I to the Directive 2001/83/CE (Directive 2003/63/CE of 25 June 2003)), these kinds of drugs are considered as biological medicines and therefore, their production, control, clinical research and the authorisation conditions are subject to the same legislation.
Since 2008, all the advanced therapy medicines require the use of the centralised procedure. That ensures the seize of the evaluation and authorisation procedure of the EU. Furthermore, it makes the products commercialization and the global access of the Member States’ patients easier. Finally, the European Commission adopted the specific Good Manufacturing Practice (GMP) guidelines for advanced therapy products in November 2017, and they are mandatory since last 22nd May 2018.