Highlights
- What is scientific advice?
- What are the benefits of taking scientific advice?
- When to take scientific advice?
- National scientific advice
- Scientific advice with the European Medicines Agency (EMA)
- Differences between national and EMA scientific advice
Scientific advice is an early regulatory deliverable, whereby pharmaceutical and biotech medicine developers can discuss different aspects of development with regulatory authorities. A medicine developer can choose to obtain scientific advice centrally through the European Medicines Agency or via individual national routes, and this article explores the differences between centralised EMA scientific advice and national scientific advice.
What is scientific advice?
A regulatory deliverable whereby a sponsor approaches a regulatory body—be it a national body or the EMA—to obtain advice on the quality, non-clinical and clinical development of a medicine.
Worth noting is that the sponsor isn’t legally obligated to take the scientific advice given. Development decisions are at the sponsor’s risk, and justification will be needed as to why the scientific advice—or certain aspects of the scientific advice given—were not followed when filing the marketing authorisation application (MAA).
What are the benefits of taking scientific advice?
There are several benefits of taking scientific advice, but foremost are:
- Prospectively understanding the potential risks to mitigate earlier in development,
- streamlining the MAA evaluation procedure, and
- reducing the risk of a negative outcome from the MAA.
When to apply for scientific advice
Scientific advice is an iterative process. Depending on the developmental aspects a medicine developer requires advice on, it can be requested at different phases of development.
Here are some examples of questions posed at different phases of development:
National vs EMA scientific advice
National scientific advice can be requested from each country’s national competent authority (NCA), which has its own process and requirements for applications, briefing materials, and fees. This advice addresses scientific or regulatory aspects of drug development, covering areas such as quality, clinical and non-clinical topics, biostatistics, and pharmacovigilance. It can be sought at any stage, from preclinical to post-authorization.
Advice meetings are now usually held virtually but can be in written form based on NCA preferences, with applicants sometimes able to choose. Key steps include submitting and validating the request, providing briefing materials, meeting with the NCA, and receiving an advice letter. Timelines vary by country; for instance, Belgium’s FAMHP provides advice within 70 days, while Germany’s BfArM may take 6 weeks to 5 months. Engaging two to three NCAs can help sponsors understand different regulatory perspectives and refine their development plan before seeking centralized advice for key topics. National advice can be helpful as a precursor to EMA scientific advice with the Committee for Medicinal Products for Human Use (CHMP). The CHMP is responsible for evaluating centralised marketing applications, and advice from this committee can be critical.
EMA scientific advice with the CHMP
Centralised scientific advice can be requested from the EMA for any human medicine at any development stage, regardless of centralisation eligibility, with orphan-designated products eligible for protocol assistance and potential fee reductions. The CHMP, advised by the Scientific Advice Working Party (SAWP), provides this advice in a 40-day written procedure, or 70 days if a meeting is involved.
The EMA has published the dates for the 2025 SAWP meetings and submission deadlines.
A preparatory meeting can be requested with a briefing package submitted 40 days in advance, or 30 days if no meeting is required, making the total process 70-100 days. EMA advice, although non-binding, helps anticipate issues the CHMP might raise during centralised marketing application evaluations, with applicants required to justify any deviation from EMA advice in future applications. Applications must be submitted through the IRIS portal, with fee reductions up to 100% available for orphan products and small or medium enterprises (SMEs), so advance planning is key.
Differences between national and CHMP scientific advice
National advice is limited to the national competent authority selected, and the process must be repeated individually for each national scientific advice procedure. Conversely, CHMP scientific advice encompasses a committee made up of experts drawn from all the national competent authorities. Additionally, national scientific advice often includes discursive advice (a meeting with the agency) compared to a (more commonly) written scientific advice letter from the CHMP. The CHMP may invite the applicant to a meeting, in which case, the advice letter is issued on Day 70 of the procedure as opposed to Day 40. However, such a meeting is at the discretion of the EMA/CHMP.
Summary
We encourage sponsors developing medicinal products to always seek scientific advice in the EU. Prospectively engaging with the regulators will help sponsors from two important perspectives…
- You don’t know, what you don’t know!
- Forewarned is forearmed!
Scientific advice is key to designing a development programme that mitigates risk, maximises success, and explores the advantages of fee reductions.
The scientific advice route you take requires a well-crafted strategy. Advanced planning is critical to selecting the right route to answer the right questions at the right time.
How Somerville Development Partners can help
We will:
- Provide expert advice on European regulatory requirements,
- guide you through the IRIS registration process,
- arrange and attend scientific advice meetings,
- draft your scientific advice briefing document, and work with you to solidify justifications for questions you pose to regulators,
- manage the operational aspects of the submission,
- respond to validation/review comments, and
- make sure you benefit from fee reductions.
To ensure we support you effectively, we will build a foundational understanding of your product and data to act as a strategic partner and proactively look out for your best interests.
