SFDA item 13 · II. Quality changes · II.1 Active substance a) Manufacture
Changes to the active substance of a seasonal, prepandemic or pandemic vaccine against human influenza
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 13 — official PDF, p. 21 ↗
| Variant | Change | Type |
|---|---|---|
| a | Replacement of the strain(s) in a seasonal, prepandemic or a pandemic vaccine against human influenza | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.I.a.5 · Changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza
| Variant | Change | Type |
|---|---|---|
| a | Replacement of the strain(s) in a seasonal, pre-pandemic or a pandemic vaccine against human influenza | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Not covered by 21 CFR 314.70 (biologic; CBER BLA, 21 CFR 601.12)
| Change | Category | Reference |
|---|---|---|
| Not an NDA/ANDA change; handled as a CBER strain-change supplement to the vaccine BLA | No US equivalent |
Note: Influenza vaccines are licensed by CBER under BLAs (PHS Act §351), not NDAs. Each season's strain update is submitted as a strain-change supplement under 21 CFR 601.12 and approved before distribution.
Other items in II.1 Active substance a) Manufacture
- 9 · Change in the manufacturer of a starting material/reagent/intermediate used in the manufacturing process of the active substance or change in the manufacturer of the active substance, where no Certificate of Suitability is available
- 10 · Changes in the manufacturing process of the active substance
- 11 · Change in batch size (including batch size ranges) of active substance or intermediate used in the manufacturing process of the active substance
- 12 · Change to in-process tests or limits applied during the manufacture of the active substance
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.