## [Saudi Arabia: Pharmaceutical Pricing Mechanisms & Rules (Draft)](/mandate/saudi-arabia-pharmaceutical-pricing-mechanisms-rules-draft) November 20, 2025 The SFDA released two draft documents outlining the process for applying new prices and the framework for pricing and re-pricing pharmaceutical products. **Key Highlights** 1\. Mechanism of Applying Prices for Pharmaceutical Products (INS198825) - Original document dated 15-Nov-2025; published on 20-Nov-2025. - Introduces the SEDRE electronic system for notifications and submissions. - Price Implementation: - New price must be applied within 90 days; the SFDA implementation period is 180 days. - Appeals: Allowed within the 180-day period. - Labeling: - After implementation period, non-removable price labels must be applied when old price is printed. - No SFDA approval needed for placing updated price labels. - SFDA Inspection: Conducted before release of updated-priced stock. 2\. Pricing Rules for Pharmaceutical Products (INS15873) - Outlines principles for pricing innovative, biological, generic, biosimilar, and combination products. - Pricing & Reductions: - Innovative product reduced by 25% upon first generic registration. - First generic ? 70% of innovative price. - Combination Products: Price must not exceed the total of individual components. - Re-Pricing: - Max 30% decrease under Article 2. - Committee may reassess price during licence changes, lack of manufacturing transfer, or marketing shifts. - Price fixed for 7 years if full manufacturing shifts to KSA. - Includes multiple pricing forms (certificate, new pricing, renewal revision, appeal, revaluation). [Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/markdownify/node/11902) Source Select Mandate HA [SFDA](/mandate-by-ha/sfda) Select Mandate Function [Regulatory Affairs](/mandate-by-function/regulatory-affairs)