Volume 26, Issue 2 - Medical Devices
News from the EMA
Conditional marketing authorisations give patients access to important new medicines earlier
January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union (EU). It allows the authorisation of medicines if the public health benefit of their immediate availability to patients outweighs the risk of an authorisation on the basis of less comprehensive data than normally required. The European Medicines Agency (EMA) has published a report on the CMA experience based on the data collected over 10 years since 2006. Since 2006, a total of 30 medicines have received a CMA. Over this 10- year period, no medicine with a CMA had to be revoked or suspended. Medicines that were granted a CMA target seriously debilitating or life-threatening conditions such as HIV infection, breast cancer, severe epilepsy in infants, or multi-drug resistant tuberculosis. Fourteen were orphan medicines, providing patients suffering from rare diseases with new therapeutic options.
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