SFDA item 19 · II. Quality changes · II.1 Active substance d) Stability
Change in the re-test period/storage period or storage conditions 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 19 — official PDF, p. 28 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Retest period/storage period — Reduction | Type IA |
| a.2 | Retest period/storage period — Extension of the retest period based on extrapolation of stability data not in accordance with ICH/VICH guidelines* | Type II |
| a.3 | Retest period/storage period — Extension of storage period of a biological/immunological active substance not in accordance with an approved stability protocol | Type II |
| a.4 | Retest period/storage period — Extension or introduction of a re-test period/storage period supported by real time data | Type IB |
| b.1 | Storage conditions — Change to more restrictive storage conditions of the active substance | Type IA |
| b.2 | Storage conditions — Change in storage conditions of biological/immunological active substances, when the stability studies have not been performed in accordance with a currently approved stability protocol | Type II |
| b.3 | Storage conditions — Change in storage conditions of the active Substance | Type IB |
| c | Change to an approved stability protocol | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 19.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.I.d.1 · Change in the re-test period/storage period or storage conditions of the active substance or intermediates used in the manufacturing process of the biological active substance
| Variant | Change | Type |
|---|---|---|
| a.1 | Re-test period/storage period — Reduction of re-test period/storage period | Type IA |
| a.2 | Re-test period/storage period — Introduction of re-test period/storage period | Type IB |
| a.3 | Re-test period/storage period — Extension of the re-test period/storage period based on extrapolation or stability modelling not in accordance with relevant stability guidelines | Type II |
| a.4 | Re-test period/storage period — Extension of re-test period/storage period supported by real time data not in accordance with an approved stability protocol or an extension based on extrapolation of stability data in accordance with relevant stability guidelines | Type IB |
| a.5 | Re-test period/storage period — Extension of a re-test period/storage period supported by real time data fully in line with the stability protocol | Type IA |
| b.1 | Storage conditions — Change to more restrictive storage conditions | Type IA |
| b.2 | Storage conditions — Change in storage conditions | Type IB |
| c | Change to an approved stability protocol | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2014 AR Guidance App. A 7.1 · 2004 Guidance §XI.A.3–4, §XI.B.1, §XI.C.2–3 (drug-product examples applied by analogy)
| Change | Category | Reference |
|---|---|---|
| Extending or introducing a retest period from real-time data on pilot or commercial batches under an approved stability protocol | Annual report | 2014 App. A 7.1 |
| Stability protocol change limited to adding time points or adopting ICH storage conditions | Annual report | 2004 §XI.C.2–3 |
| Reducing the retest period or tightening storage conditions (by analogy to shelf-life reduction) | CBE-30 supplement | 2004 §XI.B.1 |
| Extension by extrapolation or under a new or unapproved protocol, relaxed storage conditions, or other stability-protocol changes | Prior approval supplement | 2004 §XI.A.4, §XI.A.3 |
Note: Only the real-time-data extension (2014 App. A 7.1) is named for drug substance; the other changes are classified by analogy to the drug-product stability examples (§XI). Adding a stability protocol is PAS (§XI.A.2). Protein/biological substances follow 21 CFR 601.12. Drug substance stability data often sit in the supplier's Type II DMF.
Other items in II.1 Active substance d) Stability
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.