Resources & FAQs

Explore resources and get quick answers to common questions.

What Changed in Egypt’s 2026 Guideline for the Registration of Innovative Products?
What Changed in Egypt’s 2026 Guideline for the Registration of Innovative Products?

IntroductionThe 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...

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September 08, 2026
Egypt’s Draft EG Module 1 eCTD Specification: What Regulatory Teams Need to Know
Egypt’s Draft EG Module 1 eCTD Specification: What Regulatory Teams Need to Know

A practical overview of Version 1.0/2026 and what the proposed Egypt-specific eCTD structure means for Regulatory Affairs teams.Key message: EG Module 1 defines how Egypt-specific...

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September 17, 2026
New EDA Variation Guidelines 2026: Key Updates Every Regulatory Team Should Know
New EDA Variation Guidelines 2026: Key Updates Every Regulatory Team Should Know

The Egyptian Drug Authority (EDA) continues to refine post-marketing regulatory processes through updated variation pathways and clearer CTD expectations.The 2026 updates introduce...

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May 08, 2026
Egypt Adopts New Licensing Requirements for Cosmetics Manufacturing Facilities Under ISO 22716
Egypt Adopts New Licensing Requirements for Cosmetics Manufacturing Facilities Under ISO 22716

In a move reflecting Egypt’s continued efforts to strengthen industrial quality and regulatory oversight, the Minister of Industry, Eng. Khaled Hashem, issued Resolution No. 114 of...

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May 18, 2026
Egypt’s Proposed Mandatory eCTD Framework: What EDA’s Draft Guidance Means for Pharmaceutical Companies
Egypt’s Proposed Mandatory eCTD Framework: What EDA’s Draft Guidance Means for Pharmaceutical Companies

IntroductionThe Egyptian Drug Authority (EDA) has published a new draft regulatory guidance titled “Technical Guidance for eCTD Submissions in Egypt – Version 1/2026” for stakehold...

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September 09, 2026
The New 7-Year Rule: Understanding EDA's Factory Operating License Framework
The New 7-Year Rule: Understanding EDA's Factory Operating License Framework

IntroductionThe Egyptian Drug Authority (the “EDA”) has issued a new regulatory guideline governing the renewal of technical operating licenses for pharmaceutical and medical devic...

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June 01, 2026
Pharmaconex 2026: Accelerating Digital Transformation Through MODREG
Pharmaconex 2026: Accelerating Digital Transformation Through MODREG

Pharmaconex 2026 reaffirmed its position as the premier pharmaceutical manufacturing and supply chain hub in the MEA region. Convening industry leaders, regulatory authorities, raw...

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September 08, 2026
Egypt's First National Drug Policy (2026–2030): A Strategic Roadmap for the Future of the Pharmaceutical Sector
Egypt's First National Drug Policy (2026–2030): A Strategic Roadmap for the Future of the Pharmaceutical Sector

The Egyptian Drug Authority (EDA) has officially launched the Egypt National Drug Policy (2026–2030), establishing the country's first comprehensive national framework for medicine...

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July 14, 2026
New EDA Guidelines: Understanding the Framework for Products with Misuse Potential
New EDA Guidelines: Understanding the Framework for Products with Misuse Potential

IntroductionThe Egyptian Drug Authority (EDA) has issued a new regulatory guideline (EDREX: GL.CIP/PPMA.002 – Version 1/2026) introducing enhanced controls for pharmaceutical produ...

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July 04, 2026

Frequently Asked Questions

Quick answers to the most common questions about registration, payments, and platform usage.

MODREG is a cloud-based regulatory management platform designed to help companies and registration offices organize, track, and manage regulatory portfolios, product registrations, variations, deadlines, and workflows through a single unified digital system.

No. MODREG is a digital operational platform only. It does not provide regulatory, legal, or professional advice, does not represent clients before authorities, and does not guarantee approvals, registrations, or regulatory outcomes.

MODREG is provided strictly on a business-to-business (B2B) basis and is intended for: Healthcare and pharmaceutical companies, Registration offices, and Regulatory service providers. It is not designed for personal or consumer use.

MODREG is designed primarily for the Egyptian regulatory environment but can be used by local and international entities managing products targeting the Egyptian market.

No. MODREG does not replace regulatory teams or registration offices. It enhances efficiency, transparency, and coordination by organizing data, workflows, and responsibilities in one system.

No. Clients remain fully responsible for the accuracy, completeness, and legality of all data uploaded to the Platform.

Yes. MODREG applies access controls, user permissions, security measures, and audit tracking. However, Clients are responsible for managing their Authorized Users and credentials.

MODREG provides a centralized system to manage all products, registration stages, variations, timelines, assignments, and regulatory documentation in one place instead of spreadsheets, emails, or fragmented systems.

Yes. The dashboard provides senior management with a clear, real-time overview of products, regulatory status, upcoming deadlines, and portfolio health.

Yes. MODREG supports both individual product entry and bulk upload via a predefined Excel template that can be uploaded directly to the system.

Yes. Authorized administrators can assign each product or regulatory step to specific employees and monitor progress and deadlines.

All regulatory history, documents, variations, and workflows remain stored in MODREG, ensuring continuity and preventing loss of institutional knowledge.

Yes. Each variation follows its applicable regulatory system and steps, in line with Egyptian Drug Authority (EDA) rules, with full traceability and status tracking.

MODREG allows registration offices to manage multiple client portfolios in a structured, separated, and transparent way within one platform.

Yes. Registration offices may grant clients limited "view-only" access to their portfolios, depending on the subscribed package.

Yes. Each client's data is logically separated to ensure confidentiality and prevent cross-access.

No. MODREG is a workflow and data management tool. The regulatory responsibility and execution remain with the registration office.

Yes. Registration offices can generate structured reports and share them directly with clients via MODREG.

The Supplier Hub is a public-facing section where local and international suppliers can showcase their products and regulatory information to companies and registration offices targeting the Egyptian market.

Both international suppliers targeting Egypt and local suppliers seeking visibility can use the Supplier Hub.

No. Suppliers do not receive access to the internal regulatory management Platform. The Supplier Hub is a visibility and listing service only.

No. MODREG does not participate in negotiations, commercial discussions, or transactions between suppliers and other parties.

Yes. Supplier Listings are offered under paid plans and are subject to separate Supplier Listing Terms & Conditions.

MODREG offers Monthly, Annual, Enterprise, and custom subscription plans, as specified in the applicable Order Form or pricing schedule.

No. All subscription fees are prepaid and strictly non-refundable once paid, regardless of usage, partial use, suspension, or termination.

Yes. MODREG may update pricing or introduce new fees, which apply at the next renewal unless otherwise agreed in writing.

Access may be suspended or deactivated until payment is received in full. Fee obligations remain due.