Pharmaceutical companies that use AI to discover and develop drugs will likely be exempt from the need to comply with new regulatory requirements introduced under the European Commission’s AI Act, which is set to enter into force within the next two months.
AI Used In Drug R&D Likely Exempt From Tough EU AI Rules, Says EFPIA
The European Commission’s landmark AI Act will introduce strict new rules for AI systems, with the exception of products used solely for scientific research, something that could be good news for pharma, according to industry body EFPIA.
More from Europe
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
• By
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
• By
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
• By
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
More from Geography
• By
One CDRH employee said the cuts already are having a major effect on morale.
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.