SFDA item 16 · II. Quality changes · II.1 Active substance c) Container closure system
Change in immediate packaging 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 16 — official PDF, p. 25 ↗
| Variant | Change | Type |
|---|---|---|
| a | Change in the qualitative and quantitative composition. | Type IA |
| b | Qualitative and/or quantitative composition for sterile and non-frozen biological/immunological active substances | Type II |
| c | Liquid active substances (non-sterile) | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 16.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.I.c.1 · Change in immediate packaging of the active substance
| Variant | Change | Type |
|---|---|---|
| a | Change in immediate packaging of non-liquid active substance | Type IA |
| b | Change in immediate packaging of sterile liquid active substance | Type II |
| c | Change in immediate packaging of nonsterile liquid active substance | Type IB |
| d | Deletion of one of the authorised immediate packagings of the active substance | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2014 AR Guidance App. A 5.1 · 2004 Guidance §IX.C.1 · 21 CFR 314.70(b)(2)(iii), (c)(2)(i)
| Change | Category | Reference |
|---|---|---|
| Nonsterile drug substance (solid, semisolid or liquid): new container closure with equivalent protection and no increased leachables risk | Annual report | 2014 App. A 5.1 |
| Other container change that does not affect quality, incl. a size or shape change of a container for a sterile drug substance | CBE-30 supplement | 2004 §IX.C.1.b, §IX.C.1.a; 21 CFR 314.70(c)(2)(i) |
| Change that may affect sterility assurance of a sterile drug substance | Prior approval supplement | 21 CFR 314.70(b)(2)(iii) |
Note: The annual-report route requires showing equivalent protection and no increased risk of leachables (2014 App. A 5.1); without that showing the change is CBE-30 (§IX.C.1.a). Size or shape changes for sterile drug substance containers are CBE-30 (§IX.C.1.b), and changes that may affect sterility assurance are PAS (314.70(b)(2)(iii)). Protein/biological substances follow 21 CFR 601.12.
Other items in II.1 Active substance c) Container closure system
- 17 · Change in the specification parameters and/or limits of the immediate packaging of the active substance
- 18 · Change in test procedure for the immediate packaging of the active substance
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.