Lhasa Limited announces their ongoing collaboration with the European Medicines Agency (EMA), welcoming them as members and users of all Lhasa software. The agreement between the EMA and Lhasa provides access to any EU-based Medicines Regulatory Organisation. Since the EMA became members in August 2022, 17 European agencies now have access to Lhasa Limited tools.
As a scientific regulatory body, the EMA recommend to the European Commission whether medicines can be marketed in the EU. They believe in sharing knowledge to promote more effective medicine development for the benefit of patients.
Corinne de Vries, Head of Translational Sciences at EMA says of the collaboration, “At EMA we are excited to be able to use Lhasa software alongside the partners in our network. The use of data from a vast range of sources, brought together by Lhasa in a non-competitive environment helps us in a number of ways; in our assessments, in implementing ICH M7, and with our strategic ambitions on the topic of 3Rs.”
Lhasa creates software solutions that allow predictions to be made about chemical safety, therefore providing public value through:
- Faster, cost-effective drug development
- Safeguarding human health
- Limiting unnecessary animal testing.
The ability to quickly assess the safety of drugs before regulatory submission is more important now than ever. For example, the EMA finalised a review in June 2020 to provide guidance to marketing authorisation holders on avoiding the presence of nitrosamine impurities in human medicines.
Nitrosamine risk mitigation is a priority for many drug developers following the discovery of N-nitrosodimethylamine (NDMA) in valsartan (a commonly used drug in the treatment of high blood pressure and heart failure). As a result, control strategies are required to prevent or limit the presence of these impurities and others. In silico software solutions to support chemical safety assessments like those provided by Lhasa are used in conjunction with appropriate testing to reduce the risk of nitrosamine formation.
The EMA join many other regulatory organisations as Lhasa members, see our member area to find out more.
To find out more about how Lhasa can help support regulatory submissions, please get in touch.