Tips for seeking pre-submission advice from regulatory authorities

If any of you have read my previous articles – or heard me speak at events – you will have heard me frequently mention the importance of regulatory pre-submission advice (PSA). PSA is particularly important for companies working on novel foods that do not have precedents, or for which there is no guidance (or the existing guidance is not specific enough!). PSA involves consulting with regulatory authorities to receive feedback on the planned strategy and to discuss any potential questions or concerns before formally applying.

Receiving PSA can ensure that companies avoid common pitfalls that may lead to delays or rejection of their application, and may reduce the time taken during the formal review phase. One of the biggest advantages of PSA is the ability to identify potential concerns early in the process. If there are safety issues or data gaps, PSA can highlight them before the formal submission, giving companies time to address these issues. Seeking advice early can also help establish a relationship with the authorities, and engaging with them in an open and transparent manner can foster trust and ensure familiarity with the product when it is submitted.

Although PSA can speed up the review process, it may also lengthen the overall timeline if companies need to make major changes or conduct additional studies based on the feedback received. For startups needing to meet funding milestones, extended timelines pose a significant risk. PSA does not guarantee regulatory approval and is not binding, meaning that risk assessors can (and will) ask questions during the formal review.

Also, not all PSA is made equal. Although some regulatory agencies offer specific feedback and guidance on the required studies and study design, others only offer general advice. The US Food and Drug Administration (FDA) encourages applicants to engage early and often, although you need to be careful here. It is advisable to prepare slides clearly mapping out what your product is, what the intended uses are, and how you intend to demonstrate the product is safe under the proposed conditions of use. During the meeting, FDA will give you specific feedback and then send a memo summarizing what was discussed during the call. Be mindful of the Freedom of Information Act (FOIA), where interested parties can request to see what has been discussed with the FDA. Confidential business information will not be disclosed but other parties can still access non-confidential information.

PSA does not guarantee regulatory approval and is not binding, meaning that risk assessors can (and will) ask questions during the formal review

The European Food Safety Authority (EFSA) offers general pre-submission advice (GPSA) which can be requested via the EFSA.Connect platform. EFSA recently launched an initiative for SMEs to help applicants understand the updated novel food guidance (which was published in September and will apply from 1 February 2025). The call is open until 31 October. Although this initiative is very welcome, the scope of the GPSA is limited, and EFSA is not able to discuss specific study requirements or provide feedback on your proposed strategy. EFSA will prepare a non-confidential summary of the PSA, which will be published on OpenEFSA along with the non-confidential version of your dossier. The scope of PSA is defined in Article 32a of Regulation (EC) No 178/2002, so legislative change would be required if we want more expansive PSA in the EU.

My general tips for PSA are to be prepared and do your research. Do not expect the authorities to do the work for you! Think very carefully about how you frame your questions as you may get an answer you don’t want. Be mindful of their time! If they are speaking to you, then they are not reviewing ongoing applications. It is well known that regulatory agencies are currently experiencing backlogs.

Be polite! Ultimately, the authorities are giving advice and feedback in the context of the applicable regulatory framework, legislation and guidance, so be mindful that they are not trying to cause unnecessary roadblocks. They cannot bend the rules just for you.

In general, the benefits of early PSA often outweigh the cons and help to ensure you are on the right path. However, it is important to understand the risks and
prepare a robust PSA strategy.

Dr Hannah Lester is the CEO of Atova Regulatory Consulting and also Head of Regulatory Strategy at Gourmey. This article is republished from the Q4 2024 edition of Protein Production Technology International, the industry's leading resource for alternative proteins. To subscribe to all future editions, please click here