Our online conference “Brexit: What´s new for Pharma and Medical Devices”, organized in collaboration with the Department of International Trade and the British Consulate- General in Barcelona provided guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Device industries.
Our Regulatory Affairs General Manager, Lidia Cánovas emphasized the great challenge presented and the opportunities arising from the new framework established by the UK Medicines and Health Products Regulatory Agency, which is committed to innovative and rapid procedures.
She stressed that adapting to the new post-Brexit scenario is multidisciplinary and will need cross-cutting collaboration from all company departments, including development, manufacturing, regulation, pharmacovigilance and electronic filing services. Lidia also noted that structures need to be adapted in order to maintain business in the UK for medicines and, in particular, for sanitary products, which need complete recertification under the new UKCA system.
At the end of her speech, Lidia Cánovas added: “Coordination of procedures in the European Union and the United Kingdom will be necessary and strategies for the introduction of medicines should be carried out by industry in accordance with the new procedures” and highlighted the added complexity of the Northern Ireland Protocol, which should be considered in all procedures.
As for Linda Magee, Health Innovation and NHS Specialist in the Healthcare, Life Sciences and Bio-Economy Sector in the UK Government’s Department for International Trade (DIT), she analyzed the UK pharmaceutical and MedTech market, as well as opportunities for trade, investment and collaboration between the UK and Spain. She noted that the NHS (UK National Health System) is the world’s largest healthcare provider and one of the best, with population-level testing potential of more than 65 million people.
The British specialist reported a new service that seeks to help drug innovation make progress through licensing and access to the NHS: “The NHS is a key partner in the UK’s goal of delivering the best health innovations to patients faster through the accelerated access program.” An infrastructure-based program dedicated to supporting research, development and evaluation in the product innovation process; the collaboration of national agencies to expedite market entry; a wide range of location options tailored to the needs of companies; and the British Government’s commitment to innovation, supported by a sustained partnership with industry through sectoral agreements.
Among the main areas of excellence, Linda highlighted clinical trials, advanced therapies, drug discovery and manufacturing, and medical technology, including data-driven innovation and Artificial Intelligence. At the end of her speech, Linda Magee added: “It has been a great pleasure to participate in this event, to set out the opportunities for life sciences companies in the UK following the EU´s departure, together with Lidia Cánovas, from Asphalion, which was able to provide an overview of the regulations. The UK remains the number one life science cluster in Europe and is an excellent test bench for global markets. It is underpinned by means of an integrated sanitary innovation pathway from discovery, manufacturing and clinical trials, to adoption, and we look forward to supporting Catalan companies to partner with us in the future.”
In case you missed it, you still have a chance to watch the full conference here:
Looking forward to e-meeting you again next time!!