News Category: Regulatory news
The HPRA today announced it is establishing a new resource to foster and support innovation in the life sciences sector. The first initiative of its kind in Ireland, the goal of the Innovation Office is to provide regulatory advice and assistance to those developing novel health products or technologies. Ensuring that regulatory factors are considered early in the development process will help to support a timely trajectory from product concept to market access and through to patient use. The Innovation Office will be focused on directly assisting innovators to understand and comply with EU and national regulations when developing novel health products or new approaches for manufacturing or testing of such products. Ireland is ranked as the seventh most innovative economy globally. This HPRA initiative will add to a number of existing programmes and supports already in place at a national level to further develop our world leading position.
The HPRA’s Innovation Office will be a dedicated centre providing individuals, academics, SMEs, pharmaceutical and medical device companies, and other groups with an initial point of contact and access to regulatory information and advice. It will be of interest to those involved in the early development of innovative health products or technologies and queries can be submitted in respect of initial research and design, formulation, testing, clinical studies or manufacture.
According to Lorraine Nolan, Chief Executive of the HPRA, the aim is to help ensure that innovators have a clear understanding of the regulatory pathway that would apply to a new product, device or technology and that they avoid, where possible, regulatory issues which could potentially occur at the different stages of the development process.
“Ireland’s high density of innovative companies and the extensive research and development presence within academia seek to bring potentially life changing and lifesaving health products to market. As a regulator, we firmly believe that the application of our scientific and regulatory expertise can facilitate such innovation. This will ultimately lead to new products coming to market quicker as we build knowledge and awareness of both the processes involved and the supporting data that would be required to gain regulatory approval.”
The HPRA’s Innovation Office will provide regulatory support in respect of all areas regulated by the HPRA including medicines, medical devices, drug-device combination products and cosmetics. It will also have a confidential dedicated online query service, managed by a team of experienced regulatory experts.
“We are so pleased to announce the launch of our Innovation Office during Science Week 2016. This development is just one element in the HPRA’s strategic ambition to further support innovation and science across the industry sectors we regulate. We have also commenced an outreach programme with higher education institutes and research centres, and have established a Horizon Scanning Group to ensure our knowledge base keeps pace with life sciences innovation worldwide,” Ms Nolan concluded.
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. It is also hosting an Innovation Day in spring 2017 for interested parties to outline the support it is offering and to highlight developments in the area. Those who require regulatory support or further information should use the online enquiry form or e-mail the Innovation Office at innovationoffice@hpra.ie.
ENDS
FOR FURTHER INFORMATION:
Weber Shandwick PR: 01 679 8600
Rachel Galligan: 087 791 9901
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.