News
Our new position paper on in silico evidence in the regulatory approval of medical devices is out!
The Avicenna Alliance is proud to announce the recent publication of its new position paper entitled Ensuring the Quality of in silico Evidence: Application to Medical Devices. This document provides a broad explanation of the opportunities and benefits of in silico methods while also drawing attention to the urgent need for a harmonised regulatory approach supporting the acceptance of in silico evidence included in device submissions. The paper then outlines a risk-based framework for establishing the credibility requirements of in silico evidence used during regulatory decision-making.
Happy 5th Anniversary to the Avicenna Alliance!
5 years ago, based on the very enlightening Avicenna Roadmap Project Report, the Avicenna Alliance was established at the suggestion of European authorities. The initial goal was to guide authorities towards a safe and cautious, but efficient, adoption of in silico methods. The initial members were a few industrial companies who joined forces with the VPH Institute to tackle this very ambitious goal.
EU New Medical Device Regulation now in force! In silico mentioned for the first time
After a one-year postponement following the COVID-19 pandemic, the European Commission’s Medical Devices Regulation (MDR) entered into application on 26 May. The implementation calls attention to the need for enhanced availability of vitally important medical devices across the EU. Accordingly, the MDR pursues the development of a more adequate regulatory framework by improving the safety and quality of medical devices. It also seeks to provide increased transparency for patients and less administrative burden for companies. When it comes to potential implications for in silico medicine, it should be noted that the dossier specifically provides the possibility of submitting computer modelling and simulation (CM&S) data to notified bodies. As such, the implementation of the MDR could give rise to a significant boost for in silico medicine applications. However, to date no legislation was established yet on the verification and validation of these models, the assessment of simulation results, nor on standard requirements of medical device companies when submitting CM&S data to support a market authorization or when seeking reimbursement.
The European Commission adopts Communication on Europe's global approach to cooperation in research and innovation
On 18 May, the European Commission adopted a Communication on its global approach to research and innovation, entitled Europe's strategy for international cooperation in a changing world. This Communication will supersede Europe's previous strategy for international cooperation in research and innovation as a response to today's significantly different global context and align the EU's international cooperation with its current priorities.
The European Commission updates the EU Industrial Strategy
On 5 May, the European Commission published its updated EU Industrial Strategy to ensure that its industrial ambition takes full account of the new circumstances following the COVID-19 crisis. Accordingly, the Strategy will help driving the transformation to a more sustainable, digital, resilient, and globally competitive economy. The updated Strategy reiterates the priorities outlined in the previous March 2020 Communication, published one day before the WHO declared COVID-19 a pandemic.
Avicenna Alliance provides feedback on the European Commissions’ roadmap for the revision of the EU general pharmaceuticals legislation
On 27 April, the Avicenna Alliance has submitted its feedback to the revision of the EU general pharmaceuticals legislation. Through this feedback, Avicenna Members provided the European Commission with guidance on how to meet unmet medical needs, maintain a system of incentives, promote evidence generation tools for marketing authorisation of innovative medicines, and support and accelerate product development and authorisation.
