The Health Products Regulatory Authority (“HPRA”) has established an Innovation Office with a stated goal to provide regulatory advice and assistance to those developing novel health products or technologies in Ireland.
It is open to individuals, academics, enterprises, pharmaceutical and medical device companies and other groups, to submit a confidential query to a team of experienced regulatory experts. Queries can be submitted in respect of initial research and design, formulation, testing, clinical studies or manufacture.
The Innovation Office will provide an initial point of contact and access to regulatory information including compliance with EU and national regulations. This input and assistance can be availed of early in the development process. This will help avoid regulatory issues which can potentially occur at different stages and can give rise to unnecessary costs and delays.
The establishment of the Innovation office is said to be the first initiative of its kind in Ireland and is in keeping with the trend across Europe to ensure innovators have access to regulatory input early in the development process.
A link to the HPRA’s press release can be found here.
Further details regarding the Innovation Office are available on the HPRA’s website here.