The aim of national scientific and regulatory advice is to support the development of new or existing human medicinal products.
Scientific advice may be provided at any time before or after the authorisation of a medicinal product. Your questions may relate to the pharmaceutical quality, the design and conduct of non-clinical investigations and clinical trials, as well as regulatory advice.
Any party involved in the development of a medicinal product can apply. This ranges from large pharmaceutical companies to smaller academic research institutions.
Scope and process
Areas of scope for national scientific and regulatory advice include quality, pre-clinical, clinical, and regulatory questions.
We have published a guidance document on National Scientific and Regulatory advice. The guide provides more information on how to submit a request and what to expect when your request is accepted.
If you intend to submit a request, please complete the request form for national scientific and regulatory advice and email to scientificadvice@hpra.ie.
Technical and administrative service fees will apply and be calculated based on the human products fee codes. For further information, see our human products fees webpage.
Applicants should note it is not within the scope to provide a pre-assessment of data intended for a variation or marketing authorisation. The advice provided will have no bearing on the final assessment of an application to the HPRA and/or the CHMP.
Pre-submission meetings for Centralised application procedures
You can request a pre-submission meeting with the HPRA before any major centralised application procedure in which Ireland is acting as CHMP rapporteur or co-rapporteur. Examples include initial marketing authorisation, line extension, extension of indication applications.
The purpose of a pre-submission meeting is to discuss details of your upcoming procedure with the CHMP rapporteur or co-rapporteur.
Pre-submission meetings should be requested at least 3 months before the submission date of your intended application. Briefing documents must be provided to HPRA at least 30 days in advance of the meeting date. All meetings will be of 90 minutes duration.
As pre-submission meetings do not qualify as scientific advice, no application form is required, and no fee is charged by HPRA.
Please direct pre-submission meeting requests by email to cap@hpra.ie.
General guidance relating to pre- and post-authorisation submissions is available on the EMA webpages on marketing authorisation guidance and post-authorisation guidance.