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).
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