SMC has published several updated guidance and submission template documents for submitting companies for use in all full submissions and resubmissions, and also submissions considered under the Ultra Orphan Pathway. These are applicable for all relevant submissions to SMC from the January 2027 intake date onwards. Current document templates and submission guidance apply to submissions already received by SMC or those submitting at the November or December 2026 intake dates.
The following revised documents are available from the Making a Submission page on the SMC website:
- An updated New Product Assessment Form (NPAF) for use in all full submissions or resubmissions.
- An updated Guide to Submitting Companies for Completion of the NPAF.
- An updated NPAF for submissions or resubmissions as part of the ultra-orphan pathway.
- A revised guidance supplement for the completion of the ultra-orphan NPAF.
Substantial parts of the templates and guidance documents remain consistent with SMC’s existing expectations and therefore we would like to highlight where some of the main areas of change have been made within the updated Guide to Submitting Companies for Completion of the NPAF as follows:
SMC is also publishing a new consolidated process guide for submitting companies, which takes a range of current individual policy or process documents across the SMC website into a single source document. This will help to make it easier for companies to navigate all aspects of SMC processes from a single location and removes duplication of information. This process guide can be found on the Making a Submission page.
Companies should also note publication of the SMC Position Statement on the use of Artificial Intelligence (AI) in Medicines Submissions, which can also be found on the Making a Submission page. As part of the updated New Product Assessment Form templates that will apply for submissions received by SMC from January 2027 onwards, companies will be asked to provide information on the use of AI in submission preparation.
Excerpt from the official page. The original is authoritative.