SFDA item 55 · III. Safety, efficacy, pharmacovigilance changes
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 *.
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 55 — official PDF, p. 67 ↗
| Variant | Change | Type |
|---|---|---|
| - | Implementation of change(s) for which no new additional data are submitted by the MAH | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 55.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
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 |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(c)(6)(iii)(A),(E) · 2004 Guidance §X.A, §X.C
| Change | Category | Reference |
|---|---|---|
| Copy an approved RLD safety change (new or strengthened contraindication, warning, precaution or adverse reaction) | CBE-0 supplement | 21 CFR 314.70(c)(6)(iii)(A); 2004 §X.C |
| Copy other approved RLD labeling revisions where FDA directs submission under the CBE provision | CBE-0 supplement | 21 CFR 314.70(c)(6)(iii)(E) |
Note: ANDA labeling must stay the same as the RLD's (2004 §X.A: consistent with section 505(j)). In FDA's generic-drug practice, RLD-conforming updates are submitted as CBE-0 supplements, and an ANDA holder cannot use CBE-0 to depart from the RLD. Biosimilars (351(k) BLAs) follow 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).
- 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.