As part of their commitment to providing access to safe and effective medicines in the UK, the MHRA offer a variety of meeting options for Marketing Authorisation Holders and medicine developers to assist in bringing new products to the market. This blog looks at three of the most important types of meeting and how they differ from each other.
Scientific Advice Meetings (SAM)
The SAM is perhaps the first thought in many industry professionals’ minds when it comes to meetings with the MHRA, but it is not always the most suitable option. SAM is intended to provide guidance in the development of medicines to address clinical/non‑clinical/quality issues of MA Applications and also variations. These meetings can be requested at any stage in the development of the medicine and can optionally include input from NICE in a joint meeting. However, the MHRA typically prefers to hold an initial MHRA-only SAM before any joint MHRA/NICE meeting. This allows the MHRA to become fully informed on the topic and ensure they are comprehensively up to date prior to the joint discussion. All advice given in a SAM is non-binding.
A SAM will often open with a 10-15 minute presentation from the applicant, followed by up to 90 minutes of discussion with the MHRA/NICE. The MHRA may progress some requests as written-only advice if a formal meeting is deemed unnecessary.
The online request form for a SAM can be found here. This service carries a fee (varies depending on complexity, details here). Take note that a final list of questions and a briefing document should be sent to the MHRA >15 working days before the meeting is due to take place.
Pre-Submission Meetings (PSM)
The PSM can be thought of as a less scientific and more regulatory-focused alternative to a SAM. A PSM is typically requested to clarify the correct procedural submission route, address complex submission issues and timing considerations, and assess dossier readiness for an MAA. Rather than focussing on the scientific merits of a proposed new medicine, these meetings help applicants clarify strategic decisions such as whether to pursue a UK national assessment, an international route such as the IRP or the Access Consortium/Project Orbis. PSMs also provide an opportunity to discuss UK-specific requirements, such as paediatric investigation plan.
To apply for a PSM, the request form (or the IRP-specific form) must be sent to presubmission@mhra.gov.uk. You may also email the MHRA ahead of submitting this form to notify them of your upcoming request. There may be instances where you want to notify the MHRA of the up-coming submission, but don’t require a meeting. While you can specify your preference in the form, the MHRA reserves the right to request a meeting even if you have declined one. Therefore carefully evaluate the need to submit the request form. The meeting request must be submitted at least 3 months in advance of the target MAA submission date.
Note: it is strongly recommended to request a PSM for any MAA for a new active substance, biological product, line extension or new indication.
Pipeline Meetings
Pipeline meetings are a held between the drug developer/applicant and the MHRA. The applicant sets the agenda to discuss their portfolio of planned submissions over the next few years, typically up to 5 years ahead. The aim is to make the MHRA aware of what is coming so they can plan resources and handle applications more efficiently and effectively. Common discussion points include the applicant’s proposed regulatory strategy for upcoming MAAs, line extensions, new indications and complex variations. The MHRA want to be informed about timelines, introduction of novel products such as ATMPs and new active substances, and advanced notice of potential market disruptors or urgent requests.
These meetings are usually 90 minutes long and the MHRA request at least six weeks’ notice before the desired meeting date (a two-week timeslot is requested by the applicant), with the agenda/presentation sent to the MHRA at least two weeks before the meeting date. A pipeline meeting can be requested by emailing presubmission@mhra.gov.uk.
The MHRA understands that plans and timelines change. Applicants are not held accountable for dates provided, but are requested to submit updated pipeline data every 6 months to keep the MHRA informed of any changes via the completion of a spreadsheet that is sent to the pre submission team – see further details here.
Other meetings and their uses
Some of the other meeting types offered by the MHRA include:
- Access Consortium meetings, which are collaborative meetings between sponsors and multiple regulators within the consortium (including the MHRA), intended to seek to streamline submission process across the different territories, including identifying potential candidates for work-sharing and synchronising the submission timing. These do not cover any scientific or regulatory considerations (contact access-mhra@mhra.gov.uk).
- Project Orbis triage meetings for oncology products to discuss eligibility into Project Orbis (coordinated by the US FDA)
- UK PIP pre-submission discussion with the MHRA paediatric unit ahead of a new/modified UK PIP or waiver (contact ukpip@mhra.gov.uk)
- There are two types of meeting relating to the Early Access to Medicines Scheme (EAMS): Promising Innovative Medicine (PIM) scientific designation meetings and EAMS pre-submission meetings. These are for new, innovative medicines that have the potential to fulfil an unmet medical need
- Devices Regulatory Advice meetings (not applicable to medicines, relevant for drug-device combinations). Contact the MHRA (info@mhra.gov.uk) and reference “Regulatory Advice Meeting – Medical Devices”.
Which type of meeting is right for me?
While there are many points to consider when deciding which type of meeting to request, a good rule-of-thumb would be to follow this logic:
- If you need regulatory input on scientific evidence generation (e.g. clinical trial design, CMC strategy), request scientific advice (which may lead to a SAM or written advice).
- If you also need to align with Health Technology Assessment expectations, a joint SAM with NICE is recommended.
- It may save time and money to approach a consultancy to assess whether or not scientific advice would be beneficial.
- Beyond the early development stages, if you are considering your MAA strategy, you may wish to look at a PSM.
- For oncology products, consider an Orbis triage meeting to see if your product qualifies for this scheme.
- Look at booking a Pipeline Meeting to share your company pipeline portfolio for the next 3-5 years. This will enable discussions with the MHRA and ensure the MHRA is fully prepared and resourced to manage the submissions effectively.
If you would like to discuss how Fusion Pharma can support you with selecting the right type of meeting, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
