SFDA item 4 · I. Administrative changes
Change in name of the active substance
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 4 — official PDF, p. 13 ↗
| Variant | Change | Type |
|---|---|---|
| - | Change in name of the active substance | Type IA(IN) |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 4.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
E.2 · Change in name of the active substance, excipient, medical device (part), or packaging component
| Variant | Change | Type |
|---|---|---|
| - | Change in name of the active substance, excipient, medical device (part), or packaging component | Type IA(IN) |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §X.D.4 · 21 CFR 314.70(d)(2)(i); 314.70(b)(2)(v)(A),(C)
| Change | Category | Reference |
|---|---|---|
| Established name revised to follow a change in the official compendium (USP monograph title/USAN); same substance | Annual report | 2004 §X.D.4; 21 CFR 314.70(d)(2)(i) |
| Active-ingredient name change not driven by the compendium, or one touching PLR Highlights | Prior approval supplement | 21 CFR 314.70(b)(2)(v)(C) |
Note: The US established name follows the compendium/USAN, so a sponsor rarely changes it on its own; same substance means minimal risk, so compendium-driven updates go in the annual report. 2004 §X.D.4 predates the 2006 PLR rule, so confirm with the division whether a Highlights name update may go in the annual report.
Other items in I. Administrative changes
- 1 · Change in the marketing authorization holder
- 2 · Remove agent name from the artwork (Mock-up)
- 3 · Change in the (invented) name of the medicinal product
- 5 · Change in the name and/or address of a manufacturer or supplier of the active substance, starting material, reagent or intermediate used in the manufacture of the active substance (where specified in the product dossier) where no Certificate of Suitability is available
- 6 · Change in the name and/or address of a manufacturer of the finished product, including quality control sites
- 7 · Change in ATC Code /ATC Vet Code
- 8 · Deletion of a manufacturing sites (including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient, when mentioned in the dossier).
- 55 · Change in the summary of product characteristics, labeling and patient information leaflet of a generic/hybrid/biosimilar medicinal product following assessment of the same change for the reference product *.
- 56 · Change(s) in the summary of product characteristics, labeling and patient information leaflet related to post authorization safety study (PASS), periodic safety update report, risk management plan or SFDA drug safety monitoring activities.
- 57 · Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data*
- 58 · Change(s) to therapeutic indication(s)
- 59 · Deletion of
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.