SFDA item 57 · III. Safety, efficacy, pharmacovigilance changes
Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data*
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 57 — official PDF, p. 68 ↗
| Variant | Change | Type |
|---|---|---|
| - | Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data* | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
C.4 · Change(s) in the summary of product characteristics, labelling or package leaflet due to new quality, preclinical, clinical or pharmacovigilance data.
| Variant | Change | Type |
|---|---|---|
| - | Change(s) in the summary of product characteristics, labelling or package leaflet due to new quality, preclinical, clinical or pharmacovigilance data. | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(b)(2)(v)(A), (c)(6)(iii) · 2004 Guidance §X.B, §X.C
| Change | Category | Reference |
|---|---|---|
| New data add or strengthen a contraindication, warning, precaution or adverse reaction | CBE-0 supplement | 21 CFR 314.70(c)(6)(iii)(A) |
| Clinical pharmacology or clinical studies sections revised with new or modified data | Prior approval supplement | 2004 §X.B.3 |
| Labeling changes based on new nonclinical (preclinical) data | Prior approval supplement | 2004 §X.B.4 |
| Change in labeled storage conditions based on new quality/stability data | Prior approval supplement | 2004 §X.B.7 |
Note: Safety-strengthening text goes in as CBE-0 (314.70(c)(6)(iii)); other data-driven labeling changes are PAS (§X.B). Changes to PLR Highlights are PAS (314.70(b)(2)(v)(C)); for BLAs the parallel rule is 21 CFR 601.12(f).
Other items in III. Safety, efficacy, pharmacovigilance 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
- 4 · Change in name of the active substance
- 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.
- 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.