Ireland HPRA Guidance: National Scientific and Regulatory Advice
- Sharan Murugan
- 6 hours ago
- 3 min read
The Guide for National Scientific and Regulatory Advice issued by the Health Products Regulatory Authority (HPRA) outlines the framework for obtaining national scientific and regulatory advice to support the development of new or existing human medicinal products.
The objective of this advice is to guide applicants in their development programmes; however, it does not replace or substitute the applicant’s legal and regulatory responsibilities in the development of their medicinal product.
Overview of National Scientific and Regulatory Advice
Scientific advice may be requested at any stage before or after authorisation. It can cover pharmaceutical quality, non-clinical investigations, clinical trials, and regulatory matters.
National scientific and regulatory advice is provided at the discretion of the HPRA. Applications are reviewed based on completeness, expert availability, and departmental capacity. The HPRA may also recommend advice for certain application types where early engagement could facilitate smoother assessment.
This advice cannot substitute for a complete marketing authorisation (MA) application and has no bearing on the final assessment by the HPRA or the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). Advice is given in good faith and is not binding for either the applicant or the HPRA.
The scope of advice is defined by the applicant’s submitted list of questions. These should address issues not covered by existing guidelines or where interpretation is required. Pre-assessment of data for variations or marketing authorisations is not within scope, and prospective development questions are preferred.
Areas Covered by Advice
Quality Advice
HPRA provides advice on quality aspects of development, including chemical and biological products, biosimilars, antibody-drug conjugates, drug-device combinations, advanced therapies, inhalation products, continuous manufacturing approaches, Quality by Design, and bioanalytical methods for biological products.
Non-Clinical Advice
Advice covers toxicological and pharmacological development. Regulatory advice related to environmental risk assessment (ERA) may be provided; however, technical advice on ERA studies is outside the scope of this service.
Clinical Advice
Clinical advice supports planning and conduct of development programmes. It may address the legal basis of applications, dossier structure and content, procedural matters, and draft labelling. Pre-assessment of data intended for MA or variation submissions is not included.
Regulatory Advice
Regulatory advice may include changes to legal supply status, proposed labelling for product ranges, significant updates to product information, advertising considerations, post-authorisation regulatory matters, and legal basis questions for marketing authorisation applications.
When Advice Is Recommended
HPRA strongly encourages national scientific and regulatory advice in situations where assessment challenges are anticipated. This includes switches or reclassification of legal supply status, marketing authorisation applications via the national route, and applications based on Article 10a (well-established use).
Advice may not be provided in certain circumstances, such as when CHMP advice has already been obtained on the same issues or during ongoing assessment procedures.
Making a Request
Applicants must complete the official application form and briefing document available on the HPRA website. The briefing document should include a product overview, development summary, relevant marketing history, and a clearly justified list of questions.
There is no limit to the number of questions; however, standard meetings are limited to 90 minutes and should focus on key issues. Requests must be submitted electronically to scientificadvice@hpra.ie.
For standard advice, full briefing documentation must be submitted at least 30 days before the meeting. For swift advice, documentation must be submitted within seven days of acceptance.
The Advice and Timelines
Standard advice meetings last 90 minutes and are chaired by HPRA staff. Applicants must provide draft minutes within one week following the meeting. Written responses are issued within 30 days of the meeting.
For swift advice, no meeting is held, and written responses are provided within 30 days of validation. Clarification requests must be submitted within defined timelines after receipt of the written advice.
For more details on this guidance, please click the below link to access the full official document.
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