The revision of the EU pharmaceutical legislation is a unique opportunity to reshape medicines regulation in the EU.
Emer Cooke, Director of the European Medicines Agency (EMA), and Prof. Dr. Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM), talk about their current cooperation and their ideas for the future.
Artificial intelligence will change a large part of the environment in which we work, and it will also change healthcare and the development of new treatments.
PhD Björn Erikssson is Director General of the Swedish Medical Products Agency, which has been actively using AI for three years. The President of the BfArM, Prof. Dr. Karl Broich, spoke to him about the use of AI, the use of big data and the rapid developments in the European Network.
Working together for the best licensing process
Regulatory expertise on the one hand, and academic, clinical expertise on the other: if this expertise is brought together into a licensing process for new drugs, it will benefit people suffering from diseases. In a pilot project, scientists in clinical oncology now have the opportunity to get involved in drug evaluation. The BfArM is participating as a driving force at many points along the way.
CHMP
Committee for Medicinal Products for Human Use
If someone wants to get a drug licensed in the EU, they have to make an application to the European Medicines Agency (EMA). The documents are then scientifically evaluated there in the Committee for Medicinal Products for Human Use (CHMP). The committee brings together around 60 experts. They largely come from the national competent authorities, which are connected via the network of Heads of Medicines Agencies (HMA).
STARS
Strengthening Training of Academia in Regulatory Science
STARS aimed to strengthen regulatory knowledge in the academic research environment and make the clinical research more usable for the healthcare systems.
Pilot project
HMA and EMA started a pilot project oncology in May of 2023.
The focus lies on scientific mentoring and assessment of the licensing of human medicines.
The invisible ill
In Germany, there are no exact figures on the number of people suffering from Rare Disease. A problem with far-reaching consequences: without precise data, healthcare policy is missing an important decision-making basis. The BfArM wants to change this – partly to enable research and new therapies.
4 Mio
people in Germany are estimated to suffer from a Rare Disease.
The exact figure remains unknown, because the healthcare system does not have a precise coding for many of these diseases.
6000 to 8000
Rare Diseases are known.
The international reference database Orphanet meanwhile contains more than 6000 Rare Diseases, each with their own ORPHAcode.
Only 500
Rare Diseases have a specific ICD code.
The other Rare Diseases have codes which are also allocated to other, more common diseases.
Ultimately, the efficacy and safety of medicines should be increased.
Ten partner institutions from Europe are participating in the Real4Reg project, which is being coordinated by Dr. Silja Wortberg for the BfArM. Large data volumes from healthcare and artificial intelligence aim to improve regulatory processes.
