Pracelo enters into a dialogue with the European Medicines Agency

Pracelo has entered into an official dialogue with the European Medicines Agency.

On 20 March 2017, an official “pre-submission” meeting took place between the representatives of Pracelo and the European Medicines Agency (EMA). The meeting covered the regulatory questions pertaining to the registration of a medicinal product for veterinary use based on mesenchymal allogeneic stem cells intended for the treatment of degenerative joint diseases in dogs. The full registration path for the Company-developed stem cell product was discussed during the meeting. Further consultations with the EMA will be limited to scientific advice requests within the Scientific Advice procedure. The procedure will minimise the regulatory risk concerning the production of the medicinal product and its clinical trial.

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