HPRA Innovation Office

The HPRA’s Innovation Office provides regulatory support and advice to developers of new health products and technologies. The Innovation Office can assist researchers, small and medium enterprises, larger companies, or anyone else seeking to develop a health product or technology.

Timing of Innovation Office queries

The Innovation Office provides an initial contact point for innovators seeking advice or guidance from the HPRA. Queries can be submitted at any stage of development, but we particularly welcome queries during the early stages of development.

Scope of Innovation Office advice

Advice can be provided in relation to any area regulated by the HPRA including:

• Human medicines (including clinical trials)
• Veterinary medicines
• Medical devices (including clinical investigations)
• Cosmetic products
• Blood and blood components
• Tissues and cells.

The queries can relate to a new health product, or an innovative technology intended to be used in the manufacture or testing of a health product.

Type of advice available from the Innovation Office

The Innovation Office can provide advice on regulatory requirements and general guidance on technical or scientific issues that need to be considered when developing the new health product or technology.

Where more detailed scientific advice would be appropriate, the Innovation Office will provide information on how to obtain that advice.

The HPRA is also a member of the European Innovation Network (EU-IN) for medicines. Where agreed, queries submitted to the HPRA’s Innovation Office may also be shared with the EU-IN for further consideration.

How to contact the Innovation Office

The best way to contact our Innovation Office is to completer our online enquiry form. Alternatively, you can email us at innovationoffice@hpra.ie

Queries are free of charge, and we aim to respond to all queries as soon as possible and within 20 working days. All queries will be treated as confidential.

We also have a leaflet available with information from this webpage. If you wish to receive a copy in PDF or print format you can request one by emailing communications@hpra.ie.