Country guide: Egypt
Cleanroom contractor in Egypt: rules and import steps
In Egypt the Egyptian Drug Authority (EDA) approves drug factories under its GMP rules, and it does not approve the contractor. Cargo to Egyptian ports needs an Advance Cargo Information (ACI) filing, which the Egyptian importer makes on Nafeza and the foreign exporter supports through CargoX.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
EDA issued notice EDREX NP.CIP.003/2026 on 11 June 2026. Acting under Law 151 of 2019, it adopts the PIC/S GMP Guide documents for industry (EDA, 11 June 2026). EDA applied for PIC/S pre-accession on 22 September 2023 and is not on the PIC/S member list (PIC/S, 20 November 2023; checked 31 October 2026).
The General Authority for Healthcare Accreditation and Regulation (GAHAR) accredited 945 facilities across 26 governorates in the 2025/26 financial year, according to the Ministry of Health and Population (Daily News Egypt, 6 October 2026).
| Facility | Authority and rule |
|---|---|
| Drug factory | EDA, PIC/S GMP Guide adopted by notice NP.CIP.003/2026 |
| Hospital | GAHAR accreditation |
| Sea cargo | Customs, ACI under Decision 38/2021 |
Who builds cleanrooms here
The EDA chairman said on 11 May 2025 that Egypt has 170 pharmaceutical factories, 11 of them internationally accredited (Daily News Egypt, 11 May 2025). Drug factories and accredited hospitals are the main buyers.
Import steps through ACI
Decision 38/2021 covers all inbound sea shipments at Egyptian ports. It became mandatory on 1 July 2021 (AHK Egypt, checked 31 October 2026).
The Egyptian importer enters the shipment data on Nafeza. The exporter does not. The importer receives a 19-digit ACID number, valid for three months, which must appear on the bill of lading and other documents. The foreign exporter registers on CargoX and pays its fees (AHK Egypt). A foreign supplier therefore needs an Egyptian importer who is registered on Nafeza.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether EDA, GAHAR or both will inspect. Give the name of your Egyptian importer.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does EDA approve cleanroom contractors?
No. EDA inspects the owner's factory. The owner chooses the contractor.
Who files the ACI for goods shipped to Egypt?
The Egyptian importer files on Nafeza. The foreign exporter registers on CargoX (AHK Egypt, checked 31 October 2026).
Is Egypt a PIC/S member?
No. EDA applied for pre-accession on 22 September 2023, and the member list does not show Egypt (PIC/S, checked 31 October 2026).
Which GMP guide does EDA use?
The PIC/S GMP Guide, adopted by notice NP.CIP.003/2026 of 11 June 2026 (EDA).
Related guides
- Building a cleanroom inside an existing building
- What a cleanroom costs to run: energy, filters and testing
- How to Import a Cleanroom from China
- The Cleanroom Project Lifecycle
- Turnkey cleanroom contractor
- Room list builder
Sources
- Egyptian Drug Authority, Notice to applicant: adoption of the PIC/S GMP guidelines, EDREX NP.CIP.003/2026 (11 June 2026)
- PIC/S, Egypt applies for PIC/S pre-accession (20 November 2023)
- PIC/S, list of participating authorities (checked 31 October 2026)
- Daily News Egypt, healthcare accreditation body certifies 945 facilities (6 October 2026)
- Daily News Egypt, Egypt hosts 170 pharmaceutical factories, 11 with international accreditation (11 May 2025)
- AHK Egypt, FAQ on the Advanced Cargo Information System, Decision 38/2021 (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184