SFDA item 21 · II. Quality changes · II.2 Finished product a) Description and composition
Change in the shape or dimensions of the pharmaceutical form*
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 21 — official PDF, p. 29 ↗
| Variant | Change | Type |
|---|---|---|
| a | Immediate release tablets, capsules, suppositories and pessaries | Type IA(IN) |
| b | Gastro-resistant, modified or prolonged release pharmaceutical forms and scored tablets | Type IB |
| c | Addition of a new kit for a radiopharmaceutical preparation with another fill volume | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 21.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.2 · Change in the shape or dimensions of the pharmaceutical form
| Variant | Change | Type |
|---|---|---|
| a | Immediate release tablets, capsules, suppositories and pessaries | Type IA(IN) |
| b | Gastro-resistant, modified or prolonged release pharmaceutical forms and scored tablets intended to be divided into equal doses | Type IB |
| c | Addition of a new kit for a radiopharmaceutical preparation with another fill volume | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VII.B.1, §VII.C.1.a, §IX.B.4 · 21 CFR 314.70(d)(2)(ix)
| Change | Category | Reference |
|---|---|---|
| Immediate-release form: new shape or dimensions (tooling) with unchanged composition, mass and specs | CBE-30 supplement | 2004 §VII.C.1.a |
| Modified-release, gastro-resistant or functionally scored form where shape may affect release or dose division | Prior approval supplement | 2004 §VII.B.1 |
| Radiopharmaceutical kit with a different fill volume (sterile container size change) | Prior approval supplement | 2004 §IX.B.4 |
Note: The 2004 and 2014 guidances have no example for a dosage-form shape change. An immediate-release tooling change with the same composition and weight and comparable dissolution is a moderate equipment change (CBE-30, §VII.C.1.a); AR under §VII.D.1 needs same-design equipment and unchanged parameters. Where shape may affect release, it is PAS (§VII.B.1). The How Supplied/description update is AR (314.70(d)(2)(ix)).
Other items in II.2 Finished product a) Description and composition
- 20 · Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
- 22 · Changes in the composition (excipients) of the finished product
- 23 · Change in coating weight of oral dosage forms or change in weight of capsule shells
- 24 · Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
- 25 · Deletion of the solvent/diluent container from the pack
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.