HPRA Innovation Office

The HPRA’s Innovation Office provides regulatory support and advice to individuals, academics, small and medium enterprises, pharmaceutical and medical device companies, and other groups who are developing innovative health products or technologies. 

  • The Innovation Office will act as an initial point of contact for any queries or requests for advice in relation to such innovations. 
  • Queries can relate to any area regulated by the HPRA including medicines, medical devices,
    drug-device combination products and cosmetics.
  • Anyone developing an innovative product or process can submit a query to the Innovation Office. 
  • Queries can relate to a specific innovative health product or a novel technology intended to be used in the manufacture or testing of health products.
  • The Innovation Office can advise individuals or companies directly on regulatory requirements and provide general guidance on technical or scientific issues that they need to consider during the development of their product or technology.
  • Where more detailed scientific advice would be appropriate, the Innovation Office will provide information on how such advice can be obtained.
  • The Innovation Office will also provide information about regulatory and scientific issues related to innovation. The HPRA held an Innovation Day on 25th May 2017.
  • The HPRA’s Innovation Office is also a member of the European Innovation Network (EU-IN). The EU-IN has a joint mandate from both the Heads of Medicines Agencies and the European Medicines Agency reflecting their commitment to support medicine innovation and the early development of new medicines in the EU. Queries submitted to the HPRA’s Innovation Office may be forwarded for further consideration by the EU-IN on a confidential basis where agreed and considered appropriate.


Areas in which the HPRA can support innovation

The HPRA recognises that it has a key role in providing regulatory advice and support to facilitate innovation within the areas that we regulate.

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.

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.

See more detail about the advice and support available from the HPRA

Download our Innovation Office information leaflet.


Contact

If you wish to submit an innovation query please use our enquiry form. Alternatively you can email us at innovationoffice@hpra.ie.

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.


Supporting Innovation – A key strategic aim for the HPRA

Read more about the role of the HPRA and our commitment to supporting innovation