Areas in which the HPRA can support innovation
The HPRA recognises that we have a key role in providing regulatory advice and support to facilitate innovation within the following areas that we regulate:
The HPRA has scientific and clinical expertise in all of the above areas and we also have access to other experts within the European regulatory network.
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.
The HPRA can provide regulatory support from an early stage in the development of an innovative product or technology including initial research, design, formulation, pre-clinical testing, clinical studies, manufacture and post-approval research and monitoring.
If you wish to submit an innovation query please use our enquiry form. Alternatively you can email us at firstname.lastname@example.org.
Your query will be forwarded to the relevant HPRA experts in order to provide the best possible advice to support your innovation. We aim to respond to all queries as soon as possible and within 20 working days. In some cases (for example where review by multiple experts is required) the timeframe for responding to queries may be slightly longer and if this is the case we will contact you to inform you of this and advise you of the expected timeline for responding.
To maintain confidentiality the HPRA will not publish the questions received or the responses given by the Innovation Office. However, the queries will be used by the HPRA as a means of identifying areas where additional guidance could be developed.