SFDA item 49 · II. Quality changes · II.3 CEP/TSE/Monograph
Change to comply with reference pharmacopeia
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 49 — official PDF, p. 60 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Change of specification(s) of a former non-pharmacopeial substance to comply with reference pharmacopeia — Active substance | Type IA(IN) |
| a.2 | Change of specification(s) of a former non-pharmacopeial substance to comply with reference pharmacopeia — Excipient/active substance starting material | Type IA |
| b | Change to comply with an update of the relevant monograph of the reference pharmacopeia, | Type IA |
| c | Change in specifications from a reference pharmacopeia to another reference pharmacopeia. | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 49.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.III.2 · Change to comply with Ph. Eur. or with a national pharmacopoeia of a Member State for active substances, reagents, intermediates, excipients, immediate packaging materials and active substance starting materials (*5)
| Variant | Change | Type |
|---|---|---|
| a.1 | Change of specification(s) of a former non-EU Pharmacopoeial substance to fully comply with the Ph. Eur. or with a national pharmacopoeia of a Member State — Active substance | Type IA(IN) |
| a.2 | Change of specification(s) of a former non-EU Pharmacopoeial substance to fully comply with the Ph. Eur. or with a national pharmacopoeia of a Member State — Excipient/active substance starting material/reagent/ intermediate/immediate packaging material | Type IA |
| b | Change to comply with an update of the relevant monograph of the Ph. Eur. or national pharmacopoeia of a Member State | Type IA |
| c | Change in specifications from a national pharmacopoeia of a Member State to the Ph. Eur. | Type IA |
| d | Change related to a herbal active substance or herbal starting material | Type IB |
Note: Q.III.2 refers to the Ph. Eur. or a Member State pharmacopoeia; its sub-item (c) covers only a move from a national pharmacopoeia to the Ph. Eur.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(c)(2)(iii), (d)(2)(i) · 2004 Guidance §VIII.C.1.e, §VIII.D.1 · 2014 AR Guidance App. A 4.2, App. B 1.1
| Change | Category | Reference |
|---|---|---|
| Specification change to comply with USP/NF (adopting a new or updated monograph, or moving to USP/NF from another pharmacopoeia) without relaxing a criterion or deleting a test | Annual report | 21 CFR 314.70(d)(2)(i); 2004 §VIII.D.1; 2014 App. A 4.2 |
| Relaxing an acceptance criterion or deleting a test to comply with USP/NF | CBE-30 supplement | 21 CFR 314.70(c)(2)(iii); 2004 §VIII.C.1.e |
| Switching from USP/NF or an in-house standard to another pharmacopoeia in a way that relaxes a criterion or drops a test (not compliance with an official compendium) | Prior approval supplement | 2004 §VIII.B.1–2 |
Note: The official compendium is USP/NF (FD&C Act 201(j); 2004 §VIII.A). Aligning with another pharmacopoeia is not compendial compliance; it is classified by its effect on the approved specification, and any relaxation or deleted test is PAS (§VIII.B.1–2). Compendial changes to assay, impurity/degradant or biological-activity tests need a supplement (2014 App. A 4.2); related labeling updates are AR (§X.D.4).
Other items in II.3 CEP/TSE/Monograph
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.