The Egyptian Drug Authority and the law behind it

The Egyptian Drug Authority (EDA) was created by Law No. 151 of 2019, issued on 25 August 2019. The same law created the Egyptian Authority for Unified Procurement, Medical Supply and Technology Management, known as the UPA. Prime Minister's Decree No. 777 of 2020 issued the executive regulations on 29 March 2020.

EDA describes itself as a public service authority with legal personality, attached to the Prime Minister. Its mandate is to regulate and monitor the quality, efficacy and safety of medicines and medical supplies.

This article reads EDA's own guidelines: registration under Chairman Decree No. 450 of 2023 and import release under the EDA import guideline EDREX:GL.PPMA.004. Confirm current versions with your importer. Our Egypt market page gives the wider commercial picture.

Registration of imported medicines and who may apply

EDA uses a reliance route for innovator products and generics already approved by a stringent regulatory authority or prequalified by WHO. The Decree 450 guideline places imported products in tracks. Each track has a review period that runs from EDA receiving the complete dossier:

  • Track A: approved by both US-FDA and EU-EMA, plus a further reference authority or WHO prequalification. One month.
  • Track B: approved by US-FDA or EU-EMA, plus a further reference authority or WHO prequalification. Two months.
  • Track C (i): imported from a reference country, or from a non-reference country but marketed in a reference country. Three months.
  • Track C (ii): imported from a non-reference country and not marketed in any reference country. Six months.

Scientific offices in Egypt are regulated by EDA Chairman Decree No. 315 of 2021 (Regulation of Scientific Offices), which EDA's licensing guide applies to offices doing marketing and promotion for manufacturers. Product registration and import run through EDA's registration guidelines, and the registration holder is the party named in the EDA file. Ask your Egyptian partner which applicant route fits your product and which agency or authorisation documents EDA expects. For the wider route, read WHO prequalification versus national registration.

Pricing approval comes before launch

Pricing is a separate gate from registration. After EDA approves the registration request, the applicant must file with the naming, pharmacovigilance and pricing units, including the Pricing Policies Administration. The window is 15 working days for fast-track imported products (Second Case, Tracks A to C) and 30 working days for standard-track products (First and Third Case).

Under Decree 450, the pricing committee then has a maximum of 30 working days (fast track) or 90 working days (standard track) from receiving the complete pricing file.

The pricing certificate and the pharmacovigilance file are separate EDA approval steps in the registration process. Once the complete dossier and approvals are in place, the Technical Committee for Drug Control decides whether the marketing authorisation licence is issued. The price is printed on the outer pack.

The UPA and hospital procurement

The UPA describes itself as a centralised procurement and supply interface for medicines and health technology. Its stated functions include setting specifications for requesting bodies and buying on their behalf. MediQ is the UPA's electronic procurement portal for medical and healthcare tenders. Suppliers must register with the UPA to bid.

The UPA links to EDA's rules in one place. When a government entity covered by Law No. 151 of 2019 buys an unregistered product as a special request, the UPA's approval of the import must accompany the application. EDA allows special requests only where no registered, locally marketed equivalent exists, or where available quantities are insufficient. Approvals are quantity-specific and time-limited.

Press reports suggest the split of roles between the UPA and hospitals is being reworked. We could not verify a final model in official documents, so confirm who signs and who pays with the buying entity before you bid. Our government supply services and NGO procurement pages explain how M Care Exports supports institutional orders.

Import plans and release, shipment by shipment

Companies on the Pharmaceutical Importers Register obtain an annual import plan for each registered finished product from EDA, on the basis of the product's registration notification. Confirm the plan period, quantity breakdown and application lead time with your importer before the current plan lapses. The plan allows full and partial shipments.

Every consignment then needs a Sealed Medical Customs Release. The importer submits the invoice matched to the plan, bill of lading, certificate of origin, packing list, certificates of analysis for each batch and an authenticity acknowledgement. The consignment may be opened only by EDA pharmaceutical inspectors. Laboratory analysis in EDA laboratories before final release is stated for unregistered special-request products that are neither registered nor marketed in a reference country. For registered products with a reference-country CPP, the registration guideline requires an analysis file for the first shipment received after the licence is issued, and that shipment is not released until the result is issued.

EDA Chairman Decree No. 39 of 2025 bars finished products with less than two-thirds of their printed shelf life remaining, counted from arrival at an Egyptian port. The decree allows emergency exceptions only with approval from the EDA Chairman. Temperature-controlled loads need a validated chain, described under cold chain validation.

The Indian-side document pack

The Egyptian file is submitted by the applicant company in Egypt. The Indian manufacturer and exporter supply most of what goes into it. M Care Exports prepares and checks this pack alongside the importer through our CTD dossier service:

  1. A valid Certificate of Pharmaceutical Product (CPP) issued in the country of origin.
  2. A valid GMP certificate for the manufacturing site. The Technical Committee for Drug Control can also require a Site Master File and an inspection of the foreign site.
  3. The complete CTD dossier, with unredacted assessment reports and a sameness letter from the licence holder where the reliance route applies.
  4. The contract or authorisation linking your company to the Egyptian importer. EDA's import guideline asks for an Importers Register licence that names the foreign company, or an agency agreement or authorisation letter.
  5. For originator brands, the safety and efficacy studies, which go into the complete dossier.
  6. For each shipment: commercial invoice, bill of lading, certificate of origin, packing list and batch certificates of analysis.

Ask the importer which legalisation steps EDA expects for each document. M Care Exports supplies originator brands through licensed Indian channels and generics from GMP-certified manufacturers. To start, send an enquiry or open a trade account. Buyers vetting an Indian supplier can use our due diligence checklist.

Frequently asked

Who can hold the marketing authorisation for an imported medicine in Egypt?

EDA's registration guideline names the registration holder in the EDA file. Scientific offices in Egypt are regulated by EDA Chairman Decree No. 315 of 2021 (Regulation of Scientific Offices), which EDA's licensing guide applies to offices doing marketing and promotion for manufacturers. Product registration and import run through EDA's registration guidelines. Your Egyptian partner should confirm which applicant route fits your product, and which agency or authorisation documents EDA expects, before any dossier is filed. Check the requirements with EDA directly.

How long does EDA take to register an imported medicine?

The Decree 450 guideline sets review periods from the date EDA receives the complete registration dossier. They are one month for Track A, two months for Track B, three months for Track C (i) and six months for Track C (ii). The periods do not include the earlier steps: the registration request, trade-name approval, pricing and pharmacovigilance approvals. Treat them as EDA's targets, not guarantees, and expect any time spent fulfilling EDA's requests for further documents to add to your timeline. Plan the full sequence with your importer.

Is a separate pricing approval needed before an imported medicine can be sold?

Yes. After the registration request is approved, the applicant must file with the naming, pharmacovigilance and pricing units, including EDA's Pricing Policies Administration. The window is 15 working days for fast-track imported products (Second Case, Tracks A to C) and 30 working days for standard-track products. Under Decree 450, the pricing committee then has a maximum of 30 working days (fast track) or 90 working days (standard track) from receiving the complete pricing file. The pricing certificate is a separate approval step that comes before the marketing authorisation licence, and the price is printed on the outer pack. Check the current EDA guideline version.

What does the Unified Procurement Authority do for hospital supply?

The UPA was created by Law No. 151 of 2019 as a centralised procurement and supply body for medicines and health technology. It sets specifications, develops procurement policy and buys on behalf of requesting entities. MediQ is the UPA's electronic procurement portal for medical tenders, and suppliers register with the UPA to bid. For unregistered products bought by government entities as special requests, EDA requires the UPA's approval of the import. Press reports suggest its role in paying suppliers is being revised, so confirm the current model with the buyer.

Is every imported consignment tested before release in Egypt?

Every consignment needs a Sealed Medical Customs Release from EDA, and the importer supplies certificates of analysis for each batch. Only EDA pharmaceutical inspectors may open the sealed consignment. EDA's import guideline states laboratory analysis of batches before final release for unregistered special-request products that are neither registered nor marketed in a reference country. For registered products with a reference-country CPP, the registration guideline requires an analysis file for the first shipment received after the licence is issued, and that shipment is held until the result. Ask your importer how later batches are handled.

What documents does an Indian manufacturer need to supply for Egyptian registration?

The core set is a valid CPP, a valid GMP certificate for the manufacturing site, the complete CTD dossier, and the contract or authorisation linking your company to the Egyptian importer. Where the reliance route applies, EDA also asks for unredacted assessment reports and a sameness letter from the licence holder. The Technical Committee for Drug Control can require the Site Master File and an inspection of the foreign site. Each shipment then needs its invoice, bill of lading, certificate of origin, packing list and batch certificates of analysis.

Official sources

The regulators and official documents to check this guide against. Requirements change, so confirm the current version with the regulator before you file.

Working on this market?

Send the specifics. We will scope it honestly.

Molecule, strength, volume and destination. The Mumbai desk replies within one working day, including when the answer is that the route is not viable yet.

Request a quote → Book a meeting