Digital technologies and artificial intelligence are contributing to the discovery of new medicines. The pandemic years have accelerated regulatory processes and spurred innovation, says Bruno Sepodes, professor at the Faculty of Pharmacy at the University of Lisbon. In September, he was elected president of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). In Portugal, he says, the pharmaceutical sector continues to face challenges such as funding or the ability to attract and retain talent, but has experienced "remarkable development in recent decades".
What is the role of the Committee for Medicinal Products for Human Use, which you now chair, and how does its work fit into the scope of the European Medicines Agency?
The Committee for Medicinal Products for Human Use (CHMP) plays a central role in the European system of medicines regulation and the work of the European Medicines Agency. This Committee is responsible for all matters relating to medicinal products for human use in the European Union. It plays a key role in the authorisation and development of medicines in the European Union. It is therefore a major catalyst for therapeutic and technological innovation in the European Union. It evaluates new marketing authorisation applications at EU level for innovative molecules, assesses variations to existing marketing authorisations and, on the basis of recommendations from the Agency's Pharmacovigilance Risk Assessment Committee, addresses the safety of medicines on the European market by recommending to the European Commission changes to the terms of a medicine's marketing authorisation or its suspension or withdrawal from the market.
In addition to these more visible responsibilities, the Committee and its working groups contribute to the development of new medicines and the regulation of their use by providing scientific advice to companies researching and developing new medicines, by producing scientific and regulatory guidelines to help pharmaceutical companies prepare marketing authorisation applications and by working with international partners to harmonise regulatory requirements.
