SFDA item 58 · III. Safety, efficacy, pharmacovigilance changes
Change(s) to therapeutic indication(s)
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 58 — official PDF, p. 68 ↗
| Variant | Change | Type |
|---|---|---|
| a | Addition of a new therapeutic indication or modification of an approved one† | Type II |
| b | Deletion of a therapeutic indication | Type II |
| c | Changes in Generic/Biosimilar product indication while the reference product is not registered at SFDA | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
C.6 · Change(s) to therapeutic indication(s)
| Variant | Change | Type |
|---|---|---|
| a | Addition of a new therapeutic indication or modification of an approved one | Type II |
| b | Deletion of a therapeutic indication | Type IB |
C.2 · Change(s) in the summary of product characteristics, labelling or package leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product
| Variant | Change | Type |
|---|---|---|
| a | Implementation of change(s) for which no new additional data is required to be submitted by the holder | Type IB |
| b | Implementation of change(s) which require to be further substantiated by new additional data to be submitted by the marketing authorisation holder (e.g. comparability) | Type II |
Note: C.6 covers this change; where a generic or biosimilar aligns its indications with those of the reference product, the EU item is C.2.
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)(D) · 2004 Guidance §X.B.1, §X.B.5
| Change | Category | Reference |
|---|---|---|
| Delete an indication that is false, misleading or no longer supported | CBE-0 supplement | 21 CFR 314.70(c)(6)(iii)(D) |
| Add a new indication or modify an approved one (efficacy supplement with clinical data) | Prior approval supplement | 2004 §X.B.1 |
| Expand or narrow the indicated population based on data | Prior approval supplement | 2004 §X.B.5 |
| Voluntary deletion of a still-supported indication (e.g., commercial reasons) | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
| Generic indication change without a domestic reference product | No US equivalent |
Note: FDA has no separate category for a generic indication change without a reference product: an ANDA must carry its RLD's indications (patent/exclusivity carve-outs aside), and a new indication for a copy product needs a 505(b)(2) NDA. Voluntary deletion of a supported indication follows the labeling PAS default (314.70(b)(2)(v)(A)); BLA efficacy supplements fall under 21 CFR 601.12(f)(1).
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.
- 57 · Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data*
- 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.