National Scientific and Regulatory Advice

Introduction:

The Health Products Regulatory Authority can provide national scientific and regulatory advice to commercial and non-commercial entities. Further details are provided in the HPRA guideline below. 

The overarching aim is to assist applicants in the development of new or existing human medicinal products by taking into account the current knowledge of a given condition, targeted patient population, existing treatment modalities and specificities of the product being developed. The advice may assist applicants in the confirmation of guidelines, provide information where guidelines do not exist on regulatory aspects or provide assistance to non-commercial bodies such as academics intending to submit a clinical trial investigation.

Scope and process

The advice is prospective in nature and is legally non-binding for either the HPRA or applicants.
It is not within the scope of scientific advice procedure to provide a pre-assessment of data; however, the appropriateness and completeness of a marketing authorisation (MA) file before submission may be discussed.

HPRA advice can be obtained by applicants at any stage of development in terms of the quality, preclinical (with the exception of environmental risk assessment) and clinical development data.
The guidance document (see link below) provides information on submitting a request for national scientific advice and the documentation required (restricted to 100 pages). Please use the request form below when submitting a request.

All meetings will take place at the offices of the HPRA and will be of 90 minutes duration and the applicants will be requested to take minutes of the meeting.

The HPRA will provide advice to the applicants in writing within 30 days of the meeting and any clarifications will be provided within 14 days. The entire procedure request to completion is 60 days.

Fees

Technical and administrative services fees will apply and be calculated based on the HPRA fee codes 391, 392 and 393. 

The HPRA’s national scientific advice will be restricted initially to specific clinical areas:

  • respiratory medicine,
  • rheumatology,
  • obstetrics and gynaecology including fertility,
  • dermatology (common conditions),
  • radiopharmaceuticals,
  • indications for Botulinum neurotoxins,
  • common endocrine and gastrointestinal conditions,
  • generic medicines and biosimilars in the above therapeutic areas,
  • demonstration of significant benefit within the scope of the orphan drug designation.

 

Email contact:

scientificadvice@hpra.ie

Please see links to Guide and Form below:

Guide - National Scientific and Regulatory Advice
Form - Request for National Scientific and Regulatory Advice