SFDA item 48 · II. Quality changes · II.3 CEP/TSE/Monograph
Submission of a new or updated certificate of suitability or deletion of certificate of suitability: • For an active substance. • For a starting material/reagent/intermediate used in the manufacturing process of the active substance. • For an excipient.
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 48 — official PDF, p. 58 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Certificate of Suitability — New certificate from an already approved manufacturer. | Type IA(IN) |
| a.2 | Certificate of Suitability — Updated certificate from an already approved Manufacturer. | Type IA |
| a.3 | Certificate of Suitability — New certificate from a new manufacturer (replacement or addition). | Type IA(IN) |
| a.4 | Certificate of Suitability — Deletion of certificates (in case multiple certificates exist per material) | Type IA |
| a.5 | Certificate of Suitability — New certificate for a non-sterile active substance that is to be used in a sterile medicinal product, where water is used in the last steps of the synthesis and the material is not claimed to be endotoxin free | Type IB |
| b.1 | TSE Certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient. — New certificate for an active substance from a new or an already approved manufacturer. | Type IA(IN) |
| b.2 | TSE Certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient. — New certificate for a starting material/reagent/intermediate/or excipient from a new or an already approved manufacturer. | Type IA |
| b.3 | TSE Certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient. — Updated certificate from an already approved manufacturer. | Type IA |
| b.4 | TSE Certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient. — Deletion of certificates (in case multiple certificates exist per material) | Type IA |
| b.5 | TSE Certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient. — New/updated certificate from an already approved/new manufacturer using materials of human or animal origin for which an assessment of the risk with respect to potential | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 48.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.III.1 · Submission of a new or updated Ph. Eur. certificate of suitability or deletion of Ph. Eur. certificate of suitability: — for an active substance — for a starting material/reagent/intermediate used in the manufacturing process of the active substance — for an excipient
| Variant | Change | Type |
|---|---|---|
| a.1 | European Pharmacopoeial certificate of suitability to the relevant Ph. Eur. Monograph (*4) — New certificate of suitability (CEP) (including replacement or addition) | Type IA(IN) |
| a.2 | European Pharmacopoeial certificate of suitability to the relevant Ph. Eur. Monograph (*4) — Update of an approved certificate of suitability (CEP) | Type IA |
| a.3 | European Pharmacopoeial certificate of suitability to the relevant Ph. Eur. Monograph (*4) — Deletion of certificate(s) of suitability (CEP) | Type IA |
| a.4 | European Pharmacopoeial certificate of suitability to the relevant Ph. Eur. Monograph (*4) — New certificate of suitability (CEP) for a non-sterile active substance that is to be used in a sterile finished product, where water is used in the last steps of the synthesis and the material is not claimed to be endotoxin free | Type IB |
| a.5 | European Pharmacopoeial certificate of suitability to the relevant Ph. Eur. Monograph (*4) — New or updated certificate of suitability (CEP) for a herbal active substance | Type IB |
| b.1 | European Pharmacopoeial TSE certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient — New TSE certificate for an active substance (including replacement or addition) | Type IA(IN) |
| b.2 | European Pharmacopoeial TSE certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient — New TSE certificate for a starting material/reagent/ intermediate/excipient (including replacement or addition) | Type IA |
| b.3 | European Pharmacopoeial TSE certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient — Update of an approved TSE certificate | Type IA |
| b.4 | European Pharmacopoeial TSE certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient — Deletion of TSE certificate(s) | Type IA |
| b.5 | European Pharmacopoeial TSE certificate of suitability for an active substance/starting material/reagent/intermediate/or excipient — New/updated TSE certificate using materials of human or animal origin for which an assessment of the risk with respect to potential contamination with adventitious agents is required | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — No US equivalent (FDA relies on drug master files, 21 CFR 314.420)
| Change | Category | Reference |
|---|---|---|
| New, updated or deleted CEP or TSE certificate of suitability | No US equivalent |
Note: FDA does not use certificates of suitability. The US mechanism is a drug master file (Type II for APIs, Type IV for excipients) referenced by a letter of authorization (21 CFR 314.420). A new or changed API or excipient source is classified under the site, process and supplier provisions (2004 §VI–VII; 2014 App. A 1.3).
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.