What Changed in Egypt’s 2026 Guideline for the Registration of Innovative Products?
Introduction
The Egyptian Drug Authority (EDA) issued Version 2.0/2026 of the Regulatory Guideline for the Implementation of EDA Chairman’s Decree No. 388/2023 for the Registration of Innovative Products.
The new guideline was issued on 7 September 2026 and will become effective on 1 October 2026, replacing Version 1.0/2023.
The guideline provides a dedicated pathway for the registration of locally developed innovative human pharmaceutical and biological products in Egypt.
Compared with the 2023 version, the new guideline provides a clearer and more structured pathway covering early development, assessment, manufacturing, inspection and CTD submission.
So, what has changed?
1. Scope
2023:
The guideline covered locally manufactured human pharmaceutical and biological products that had not previously been registered in Egypt or abroad and provided a new therapeutic benefit.
2026:
The definition of local manufacturing is now clearer: at least one manufacturing step, other than primary or secondary packaging, must take place in Egypt.
The guideline also clearly excludes herbal medicinal products, dietary supplements with therapeutic claims and medical devices from this pathway.
2. Types of Innovative Products
The 2026 guideline provides greater clarity on the products that may qualify as innovative.
The product may involve:
- A new active substance
- A new formulation with a different mechanism of action
- A novel modification
Innovation continues to be classified as either Breakthrough Innovation or Incremental Innovation.
This gives companies a clearer starting point for determining whether their product may qualify for the innovative-products pathway.
3. Earlier Importation of Raw Materials
2023:
Importation and sealed medical customs release of raw and packaging materials were linked to the registration notification or approval to proceed with registration procedures.
2026:
This can now start based on approval of the Inquiry Request, subject to the applicable importation and customs-release requirements.
The key change: access to materials required for development can begin earlier in the regulatory pathway.
4. Earlier Trade Name Process
2023:
The proposed trade name was submitted after approval by the Scientific Committee.
2026:
The process starts after Inquiry Request approval, with proposed names submitted within 30 working days, renewable once.
Companies initially submit 15 proposed names, with a maximum of four lists.
If all four lists are rejected, the product will use the Non-Proprietary Name + Company Name.
5. Multidisciplinary Assessment
The 2026 guideline introduces a more structured Multidisciplinary Assessment Team.
Following submission and screening of the Designation Application, relevant EDA administrations participate in the assessment according to the nature of the product.
The team prepares its assessment report within 90 working days.
This creates a more clearly defined assessment pathway compared with the previous scientific evaluation process.
6. A Structured Three-Year Development Period
The development period itself is not substantially longer: the previous guideline provided 36 months, while the new guideline provides a period not exceeding three years.
The important change is how this period is managed.
Under the 2026 guideline, the company establishes a defined Development Time Plan covering the required studies and preparation of the CTD dossier.
In addition, the company must provide EDA with a quarterly update on the status of product development.
So, the three-year period becomes a planned and monitored development pathway, rather than simply a deadline for dossier submission.
7. Rolling Submission and Rolling Review
One of the most important additions is the introduction of Rolling Submission and Rolling Review.
During the three-year development period, companies may choose to submit parts of the registration dossier progressively for review instead of waiting until the entire dossier is complete.
This provides greater flexibility during the development of innovative products and allows regulatory review to progress alongside product development.
8. Manufacturing-Site Inspection
The new guideline clearly addresses inspection of the:
- Active substance manufacturing site
- Bulk production site
- Finished-product manufacturing site
These sites are subject to inspection to verify compliance with GMP requirements.
An important exception applies to sites approved by a Reference Regulatory Authority or holding WHO Prequalification, which are exempted from the inspection visit under the guideline.
9. CTD Submission and Assessment
The 2026 guideline specifically refers to preparation of the registration dossier according to ICH M4 CTD Guidelines.
For a complete dossier, the pathway includes:
Initial Screening — 30 working days
Technical Assessment — 120 working days
Together with the option for rolling submission, this provides companies with a clearer framework for planning dossier preparation and regulatory review.
What Does This Mean for Companies?
The 2026 update is not simply a revision of registration requirements. It creates a more structured pathway for managing an innovative product from early development through registration.
The major changes can be summarized as:
Clearer scope → clearer definition of innovation → earlier raw-material importation → earlier trade-name process → multidisciplinary assessment → monitored three-year development → rolling submission and review → clearer manufacturing-site inspection → structured CTD assessment.
For companies developing innovative medicines locally, the key message is therefore to plan the regulatory strategy alongside the development strategy from the beginning, rather than waiting until the CTD dossier is complete.