EMA and FDA have activated plans to fast track the development and approval of therapeutics against COVID-19.
EMA has a range of support measures that facilitate and speed up the development of medicines, including scientific advice, the PRIME scheme, the accelerated assessment and conditional marketing authorization procedures. These programs have been created to support the development of medicines that address unmet medical needs, and have now been made accessible for COVID-19 treatments. In addition, EMA provides scientific advice free of charge and under fast-track timelines for any Covid-19 program. The US FDA has a similar set of measures, known as the Corona Treatment Acceleration Program (CTAP).
Our Dossier Development team is thoroughly informed about the details of these newly installed programs. Please contact us to find out how we can support the acceleration of your drug development project. Our team can also give support in other regulatory challenges related to COVID-19 such as changes of manufacturing sites or registration of alternative suppliers.
For more information, please contact us.