Updated submission templates and guides for submitting companies and position statement on the use of artificial intelligence (AI) in medicines submissions
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:
|
Key area of change |
Relevant section in the updated Guide to Submitting Companies on completion of the NPAF document |
|
Reference to SMC position statement on Real World Evidence |
Section 3a, pages 17 & 21 |
|
Suggested tables for reporting of methodology and results for clinical evidence |
Section 3a, pages 20 & 21 |
|
Use of the PRO EDI table to summarise patient characteristics for each clinical study |
Section 3a, page 20 |
|
Additional guidance on use of surrogate outcomes |
Section 5b, page 31 Section 6.7.4, page 42 Section 6.13, page 54 |
|
Use of a reference case in economic evaluations |
Section 6.5, page 38 |
|
Selection of comparators (SMC not recommended/ interim accepted/ ultra-orphan initial assessments) |
Section 6.7.2, page 42 |
|
Use of patient-only perspective as the base case for use in economic evaluations |
Section 6.7.3, page 42 Section 6.9.2, page 47 |
|
Role of expert opinion and structured expert elicitation methods |
Section 6.8.5, page 45 |
|
Contract pricing in economic evaluations |
Section 6.10.2, page 48 |
|
Handing of confidential patient access scheme (PAS) discounts and contract pricing for comparators, combination and subsequent therapies within the economic evaluations |
Section 6.10.3, page 49 |
|
Sensitivity analysis and standard reporting of results in economic evaluations |
Section 6.13, page 53 Section 6.14, page 54 |
|
Equity and environmental considerations |
Section 6.15.2, page 56 Section 6.15.3, page 57 |
|
Thresholds for decision-making |
Section 6.16, page 58 |
|
Integration of existing budget impact template guidance into NPAF guidance |
Section 7, page 62-66 |
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.