Basel, 4 November 2020
A report on the 7th Medtech & Pharma Platform Annual Conference held on 22-23 October 2020, was published in the latest issue of the MedNous Journal. The report entitled “Meeting Report: Preparing for a digital future” outlines current and future Combined Product regulations presented in the keynote address by the Head of the European Medicines Agency’s (EMA) Digital Business Transformation Task Force, Zaide Frïas. The report highlights key aspects presented in the address, from recognition of the rapid progress in science and technology, to a need for the EMA to anticipate these new technologies and understand how they can be deployed. This includes considering how to adapt regulatory frameworks to respond to the challenges of innovative Combined Products. To this end, Ms Frïas suggested an integrated regulatory pathway could be created between the notified bodies and medicinal product regulators to facilitate consultations and assessment of Combined Products.
The article also discusses two innovative medical products discussed by Ms Frïas that fall under the MPP’s definition of Connected Combined Products (CCPs). The definition of CCPs was published in the MPP’s recent Position Paper on the legislative framework for Connected Combined Products that can be read here.