Regulatory Issues
Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia.
A new pilot project to support the repurposing of medicines has been launched by EMA and the HMA in October 2021. It’s a follow-up project to the STAMP’s discussions on a proposal for a medicines repurposing framework from June 2019.
The EMA aims with this new initiative to support not-for-profit organisations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication. Evidence should be sought in view to have this new use formally authorised by a regulatory authority. Such repurposing is a way of making new treatment options available to patients.
EFPIA has been part of designing the pilot framework and is part of STAMP’s Repurposing Observatory Group.
Investing in European Research
Researchers are facing overwhelming numbers of national and international regulations regarding Intellectual Property Rights (IPR), and regulatory issues in the context of clinical application. Genuine ideas and novel results, from which IPR can be generated, are common in proposals and projects included under NEURON’s JTCs. Here you find a set of guidance documents and sample templates.
STARS
The CSA Strengthening Training of Academia in Regulatory Science (STARS) published a Comprehensive Inventory (CI). The purpose of this CI is to assist European academic drug developers in finding support on regulatory affairs. The inventory lists various support services provided by national competent authorities, public actors and private entities. The tool will help researchers to in find specific information based on country, expertise area and support scope.
The STARS consortium organised in February 2021 a 4-day online training for academia with topics on basic regulatory knowledge and specific regulatory requirements. Titled ‘The Winding Road from a Brilliant Idea to Drug Approval’ the course covered topics on essential regulatory knowledge, case examples, insights into the regulatory system, as well as direct interaction and question & answer sessions with regulators and clinical assessors. The training course presentations are now available. This event represents Pilot I and is one of three STARS pilots foreseen by the EC funded consortium.