SFDA · EU · US FDA
Variation Compass
One post-approval change, classified by SFDA, the EU and the US FDA, side by side.
Do and tellIAARSFDA: compiled yearly, by 31 January · EU: annual update · US FDA: annual report
Do and tell immediatelyIAINCBE-0SFDA: within 14 days of implementing · EU: immediately after · US FDA: file first, distribute on FDA receipt
Tell, wait and doIBCBE-30SFDA: wait “a period of time (please refer to latest edition of the framework)” · EU: 30 days · US FDA: 30 days after FDA receipt
Prior approvalIIPASApproval before implementing — all three
IA, IB, II — SFDA and EU variation types (IAIN: notify immediately) · AR — annual report · CBE-0 / CBE-30 — supplement, changes being effected now / in 30 days · PAS — prior approval supplement · Admin — administrative correspondence, no supplement. The pairs are analogous, not identical; in the US the applicant assesses the change under 21 CFR 314.70 to decide its category.
Sources and reuse
SFDA Saudi Food and Drug Authority
- Guidelines for Variation Requirements v6.3 (DS-G-006)
Saudi Food and Drug Authority, Drug Sector; issued 19 Aug 2019, in force 7 Oct 2020. © SFDA. Each item links to its page in the official PDF, where the condition and document texts are. Not an official SFDA publication.
EU European Union
- Guidelines on the details of the various categories of variations — C/2025/5045
© European Union, 2025. Reuse authorised under Commission Decision 2011/833/EU provided the source is acknowledged; only the Official Journal text is authentic. Corrigendum C/2025/90105 affects the Spanish version only.
US FDA US Food and Drug Administration
- 21 CFR 314.70 · Changes to an Approved NDA or ANDA (2004) · CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (2014)
U.S. Government works in the public domain. FDA has not reviewed or endorsed this site. FDA publishes no classification table: “Stated in FDA guidance” means the guidance names the change; “By analogy” means the category follows from the closest example under 21 CFR 314.70. Biologics licensed by CBER follow 21 CFR 601.12 and veterinary products FDA CVM rules, outside 21 CFR 314.70.
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing.