The Health Products Regulatory Authority (the "HPRA") has established an Innovation Office (the "Office") aimed at supporting the development of novel products in the life sciences sector.
WHAT THIS MEANS FOR THE INDUSTRY
This Office will provide regulatory advice to developers of new products and technology and will be particularly interesting to those involved in the initial stages of development of a new product.
The services will be targeted to innovative or novel products, particularly:
- new treatments for conditions with no current treatment options;
- vaccines, advanced therapy products or novel medical devices;
- targeted-drug delivery systems;
- new technologies or approaches for the manufacture or testing of medicinal products or devices such as nanotechnology and continuous manufacturing;
- new diagnostics using novel or established technologies; and
- novel formulations for cosmetic products.
Interested applicants can submit a request for advice for which the Office aims to provide a response within 20 working days. If more detailed advice is necessary, the Office will redirect the applicant.
REMARKS
A focused approach to innovative products would certainly be welcomed by industry and academia alike and it is hoped that this will encourage further development of innovative products in Ireland. However, it remains to be seen how this service will provide added value to the current regulatory support services made available by the HPRA which applies to both innovative and non-innovative products alike.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.