EMA publishes report on conditional marketing authorisations

The European Medicines Agency (EMA) has published a report on the impact of conditional marketing authorisations (CMAs). From 2006 until June 2016, a total of 30 CMAs were granted. The report highlights the positive impact that CMAs have had on providing access to new medicines for patients with unmet medical needs. CMAs can speed up access to medicines for patients with seriously debilitating or life-threatening conditions. Of the 30 medicines granted a CMA, 14 were orphan medicines. CMAs are one of the tools available to regulators to support the development of and early access to medicines. If you are developing new medicines for the EU and would like to discuss how this initiative may apply to you, please contact us on uk@pharmalex.com or call +44 (0)1628 530554.

For more information on EMA publishes report on conditional marketing authorisations talk to PharmaLex UK Services Limited