The Scottish Medicines Consortium (SMC) has revised its submission templates and guidance, with new requirements applying to full submissions, resubmissions and ultra-orphan assessments received from the January 2027 intake.
The updates include revised New Product Assessment Forms, corresponding company guidance and a consolidated process guide. Submissions already received, or submitted at the November and December 2026 intakes, will continue under the existing documents.
SMC has added suggested tables for reporting clinical study methods and results and a standard format for summarising patient characteristics. The guidance also expands its treatment of surrogate outcomes, expert opinion and structured methods for obtaining expert estimates where evidence is limited.
For economic submissions, the revised guidance addresses use of a reference case, selection of comparators, presentation of alternative assumptions and sensitivity analyses. It gives more specific instructions for confidential patient access scheme discounts and contractual prices for comparators, combination treatments and subsequent therapies. Existing budget-impact guidance has been incorporated into the main submission guide.
A new SMC position statement on artificial intelligence accompanies the documents. From the January intake, companies must provide information in the revised forms about any use of AI to prepare their submissions. SMC has not presented AI-generated material as a replacement for the evidence and analyses normally required.
This update makes evidence presentation, confidential price assumptions and disclosure of AI assistance more explicit at the point of submission.
Source: Scottish Medicines Consortium
Link: Updated submission templates and guides for submitting companies and position statement on the use of artificial intelligence (AI) in medicines submissions
Date: 22 October 2026
