The establishment of DARWIN EU is relevant for the in silico community as it aims to quicken the delivery of reliable evidence for regulatory decision-making for innovative medicines utilising data, for which computer modelling and simulation may play a significant analytical role.
DARWIN-EU plans to catalyse a “paradigm shift” to the usage of real-world evidence for health regulation, which has been an important claim from the innovative pharmaceutical industry in the last years.
- During the late February launch webinar, the EMA presented the objective of the “DARWIN EU” initiative as providing the EMA and national competent authorities access to valid and trustworthy real-world evidence (RWE) on diseases, patient populations and on the use of safety and effectiveness of medicines throughout the lifecycle of a medicinal product. By 2025, the EMA would like the use and value of RWE to be established in the EU for regulatory decision making.
- These data will support decision-making on development, authorisation and surveillance of medicines and are expected to benefit patients, healthcare professionals, HTA bodies and the pharmaceutical industry. In particular, the EMA outlined the specific benefits of real-world evidence to support the quick availability of innovative medicines to patients.
- This initiative is tied to the reinforced role of the EMA, which will be in effect as of 1 March 2022, as well as the European Health Data Space, to which it will eventually connect. It also supports HERA in ensuring the ability to quickly respond to health crisis through tasks such as monitoring the supply of medicines to address demands and identify shortages.