Introduction

On 23 September 2026, the Egyptian Drug Authority (the “EDA”) issued decree no. 480 of 2026 (the “Decree”), introducing new controls and procedures governing the pricing and repricing of human pharmaceutical products in Egypt. The Decree defines human pharmaceuticals as “Any product or preparation containing a substance or combination of substances used for the treatment, prevention, or diagnosis of disease in humans, or claimed to have a medical effect, or intended to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action, in accordance with applicable standards and guidelines, as well as any preparations or substances introduced in light of scientific advancements and/or international standards and guidelines. They are categorised into locally manufactured products and imported products” (the “Human Pharmaceuticals”).

The Decree establishes pricing mechanisms for innovator, generic, biological and biosimilar products, with the aim of protecting patients, encouraging investment, safeguarding competition, and maintaining economic balance across the pharmaceutical sector.

Scope of Application and Entry into Force

The Decree applies to Human Pharmaceuticals’ pricing and/or repricing following its issuance. It enters into force on 24 September 2026, and repeals any provisions that contradict it.

Key Provisions

1. Pricing of Innovator Products

• Rule:

Innovator products submitted for pricing for the first time, as well as those previously priced products but not yet circulated in Egypt, will generally be priced based on the external reference pricing system, using the lowest ex-factory price in the reference countries, listed under Annex 1 of the Decree, in addition to the applicable distributor and pharmacist margins.

• Exceptions:

1. products with a lowest reference price ranging between EGP 50,000 (fifty thousand Egyptian pounds) and EGP 500,000 (five hundred thousand Egyptian pounds) will be subject to a value-based pricing mechanism, including economic evaluation or multi-criteria decision analysis (“MCDA”), as applicable;
2. products exceeding EGP 500,000 (five hundred thousand Egyptian pounds) will be priced according to the lowest available ex-factory price in countries where the relevant product is marketed, whether or not such countries are included in the EDA’s reference-country list. Such pricing will be subject to close-interval periodic reassessments;
3. in case an innovator product is priced after a generic or biosimilar product’s local registration and circulation, the innovator one will be priced at a 35% (thirty-five per cent) premium over the generic or a 20% (twenty per cent) premium over the biosimilar, as applicable; and
4. in case of registering an innovator product when three (3) generic and/or biosimilar products are sufficiently available in the local market, as determined by the EDA, that innovator’s pricing will be reduced by 20% (twenty per cent) or to the lowest reference-country price, whichever is lower, subject to the limits prescribed under the Decree. Imported innovator products for full localisation are excluded from such a reduction for at least five (5) years from their local circulation.

2. Pricing of Generic and Biosimilar Products

• Generic and biosimilar products submitted for pricing for the first time, as well as those previously priced products but not yet circulated in Egypt:

1. for generic products, the first generic will be initially priced at 65% (sixty-five per cent) of the innovator price, where a re-assessment will take place upon completion of the registration procedures against the innovator’s price, as follows:
   1. the first at 70% of the innovator’s price,
   2. the second and third at 65% of the innovator’s price,
   3. the fourth and fifth at 60% of the innovator’s price, and
   4.  the sixth and subsequent products at 50% of the innovator’s price.

2. for biosimilar products, the first biosimilar will be initially priced at 75% (seventy-five per cent) of the innovator price, where a re-assessment will take place upon completion of the registration procedures against the innovator’s price, as follows:
   1. the first biosimilar will be priced at 80% of the innovator’s price,
   2. the second and third at 75% of the innovator’s price,
   3. the fourth and fifth at 70% of the innovator’s price, and
   4. the sixth and subsequent products at 60% of the innovator’s price.

3. imported biosimilars from non-reference countries will be subject to a further 5% (five per cent) reduction.

• The pricing mechanism above must not result in a generic or biosimilar product being priced above its price in reference countries and/or its country of origin.
• Further requirements apply when pricing a generic or biosimilar product before the innovator’s pricing in the local market, and when similar generics or biosimilars are already circulated locally.

3. Repricing

• The Decree introduces a reassessment mechanism for circulated-products’ prices, in the event of economic changes, including foreign exchange rates change, inflation rate, and the Central Bank of Egypt interest rate change; which directly affect the Human Pharmaceuticals’ importation and manufacturing expenses (“Economic Changes”).
• The applicable formula when increasing or decreasing Human Pharmaceuticals’ prices considering the Economic Changes, is calculated at 60% (sixty per cent) for foreign exchange-rate movements, 30% (thirty per cent) for inflation and 10% (ten per cent) for interest-rate movements (“Equation”).
• Such an Equation is proposed to be calculated every six (6) months as of the Decree’s issuance, where the EDA may conduct an earlier assessment in exceptional circumstances.
• A price increase adjustment may be implemented, upon the Human Pharmaceutical marketing authorisation holder’s request, where the resulting increase is at least 10% (ten per cent) and the relevant Economic Changes have continued for at least forty-five (45) days.
• A price decrease adjustment may be implemented by the EDA, where the resulting decrease is at least 10% (ten per cent) and the relevant Economic Changes have continued for at least forty-five (45) days.
• The EDA will review each relevant company’s Human Pharmaceuticals pricing every three (3) months.
• Human Pharmaceuticals’ marketing authorisation holders may separately request a reassessment of their circulated products, for the EDA’s discretionary review, provided at least six (6) months have elapsed since the relevant product’s last pricing certificate issuance. That request must be supported by the related direct and indirect cost impact data.
• The EDA reserves the right to review and potentially reduce Human Pharmaceuticals prices based on data from the pricing study, including cost details for local or imported products, market prices in reference countries, prices of available therapeutic equivalents and alternatives, and economic evaluation studies, without being bound by the validity period of the pricing certificate. The reduced price shall apply to batches produced or imported after the issuance of the pricing certificate specifying the reduced price.
  
  This reduced price shall be taken into account when pricing generic or biosimilar products subject to Article 4 of the Decree.

4. Distributors’ and Pharmacists’ Margins

• The Decree introduces different distributor and pharmacist margins depending on whether a Human Pharmaceutical is locally manufactured or imported, whether, as a local product, it appears on the essential medicines list or not, and whether the Human Pharmaceutical’s pack retail price is above or below EGP 500 (five hundred Egyptian pounds).
• For locally manufactured products, on and off the essential medicines list, distributor margins generally range between 5.8% and 8.5%, while pharmacist margins range between 20% and 27%.
• For fully finished imported products, distributor margins are 7.4% or 4.8%, depending on the applicable price bracket, while pharmacist margins are 19% or 15%, respectively.
• In cases where distributors’ margins exceed EGP 500 (five hundred Egyptian pounds) and pharmacists’ margins exceed EGP 1,500 (one thousand five hundred Egyptian pounds) in compliance with the mechanism above, their margins shall be fixed as per the amounts specified under Annex 2 of the Decree.

5. Marketing Authorisations, Pricing Certificates, and Appeals

• Human Pharmaceuticals marketing authorisations shall remain valid for five (5) years, with their holders being required to submit a repricing request three (3) months before expiry, without prejudice to the EDA’s right of price review under Article 6 of the Decree.
• Pricing certificates of Human Pharmaceuticals priced above EGP 50,000 (fifty thousand Egyptian pounds) shall remain valid for two (2) years, with their holders being required to submit a repricing request two (2) months before expiry, without prejudice to the reassessment periods applicable to Human Pharmaceuticals exceeding EGP 500,000 (five hundred thousand Egyptian pounds), as set forth under Article 3 of the Decree.
• Marketing authorisation holders may appeal an EDA-imposed price within a maximum of three (3) months from notification. Where an appeal is submitted, the EDA decides on it within two (2) months as of the appeal’s submission.

6. Human Pharmaceuticals’ Circulation Requirement

Pharmaceutical institutions must not display or sell products at prices different from the approved in the pricing certificate, except with the EDA’s prior approval in connection with patient-support programmes or EDA-approved incentive discounts, and without prejudice to the applicable laws.

7. Return of Expired Human Pharmaceuticals

• Without prejudice to any regulatory decrees in relation to expired Human Pharmaceuticals recall, pharmacies may recover paid amounts for expired Human Pharmaceuticals returned to the relevant distributor, manufacturer or importer up to 3% (three per cent) of the relevant purchase invoices for each product.
• Distributors benefit from a corresponding right in relation to expired products returned to manufacturers or importers, up to 3% (three per cent) of the relevant purchase invoices for each product.
• This applies to purchase invoices issued as of the effective date of the Decree.

Disclaimer

This document is for informational purposes only and does not constitute legal advice.

The contributors to this article are Fagr Moheb, Senior Associate; and Alaa Mohamed, Junior Associate.