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EMA providing support for developing orphan medicines by academics

7 December 2020

The European Medicines Agency (EMA) have published an article on providing support for medicine development by academics and clinical researchers. The launch of free scientific advice to academia and non-profit research organizations developing orphan medicines, can help align research with regulatory requirements early during medicine development and enhance the chances of success.

In the article some of the key elements of this collaboration are summarised, and an important step to enhance it is highlighted: the EMA has completely waived the fees for providing tailored scientific advice to academia and non-profit research organizations developing orphan medicines. The initiative responds to a previous call from academia to address some of the challenges encountered by non-profit organizations developing medicines when navigating the regulatory system in the European Union (EU).

The complete article is to be read on https://www.nature.com/articles/d41573-020-00205-x