News Category: Regulatory news
The HPRA today stated that its new Innovation Office, which was launched in late 2016 to assist innovation in the life sciences sector, has provided support to over 20 companies and individuals seeking to develop new health products and technologies in Ireland. The queries submitted to the HPRA related to the development of medical devices (43%), medicines (33%) as well as other specialist products and cosmetics (24%). These figures were announced as the HPRA held its first Innovation Day with the conference bringing together 250 researchers, entrepreneurs and other interested parties to discuss the regulatory supports available to those developing novel health products and technologies.
The HPRA explained that of the enquiries submitted to its Innovation Office, two thirds of the queries emanated from SMEs and academia, with the remaining queries submitted from other life sciences companies, individuals and research consortia. The HPRA’s Innovation Office was established as an initial point of contact and support for innovators with queries relating to products and technologies within the HPRA’s remit.
Ms Lorraine Nolan, Chief Executive, HPRA said, “Enhancing communication and strengthening the links between academia, industry and regulators is a key support for a sector which is highly dynamic and innovative. At our Innovation Day event today in UCD, leading scientific and business experts came together to discuss how best we can facilitate innovators here in Ireland. Ideally, if we can collectively identify regulatory queries and issues at an early stage in the development of a health product then by working together we can address these issues to help facilitate the delivery of innovative products and technologies to the market. Ultimately, the goal is to ensure patients have timely access to the most effective and safe health products possible.”
She continued, “The purpose of the HPRA establishing the Innovation Office is to support the highly innovative life sciences environment in Ireland and to strengthen our engagement with innovators. It is clear there is a huge appetite for regulatory support among health product innovators; Ireland already contributes significantly to health product research, development and innovation at an EU and international level, and the HPRA strives to maintain and expand its regulatory supports to facilitate the continued growth in this essential sector in Ireland.”
The HPRA’s Innovation Office provides regulatory support in respect of all areas regulated by the HPRA including medicines, medical devices, drug-device combination products and cosmetics. It also has a confidential, dedicated online query service, managed by a team of experienced regulatory experts. Health product innovators can submit their queries relating to initial research and design, formulation, testing, clinical studies or manufacture.
The establishment of the Innovation Office forms one action from the HPRA’s strategic objective to further support innovators in Ireland; it has also developed programmes in education and outreach, horizon-scanning and classification to assist in identifying and meeting the requirements of this sector. These activities are complemented by additional supports offered in specific areas such as national scientific advice related to the development of medicines and innovation workshops which provide guidance in relation to clinical research for medical devices.
The HPRA has developed a dedicated section on its website and published an information leaflet with details of the support and advice that is available through the Innovation Office. Those who require regulatory support or further information should use the online enquiry form or e-mail the Innovation Office at firstname.lastname@example.org.
NOTES TO EDITOR:
In general, innovation will involve the development of a novel concept, idea or approach into a prototype, product or technology that offers real and practical benefits for patients, health providers or the life sciences sector. Innovation could relate to:
- new treatments for use in conditions where there are currently no or limited treatment options;
- innovative types of products such as vaccines, advanced therapy medicinal products (which can be based on genes, cells or tissues) or novel medical devices;
- targeted-drug delivery systems aimed at maximising efficacy or minimising adverse effects such as antibody-drug conjugates;
- new technologies or approaches for the manufacture or testing of medicines or devices such as nanotechnology and continuous manufacturing;
- new diagnostics using novel or established technologies;
- novel formulations for cosmetic products.
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ABOUT THE HPRA
The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.