Submit RFI/RFP
Request Consultation
On 10 February 2026, the Egyptian Drug Authority (EDA) announced the launch of a public consultation on a new draft regulatory guideline titled:
Guideline for Content File of Biological Products for Registration & Re-Registration File
This initiative reflects the Authority’s ongoing commitment to keeping pace with the latest scientific and regulatory developments, while ensuring the availability of advanced high-technology biological products that meet standards of quality, safety, and efficacy.
Scope of the Draft Guideline
The draft has been issued by the Central Administration for Biological and Innovative Products and Clinical Studies. It outlines the regulatory requirements and dossier structure for:
- Initial registration of biological products
- Re-registration submissions
- Content and documentation expectations for biological product files
The guideline aims to enhance clarity, consistency, and regulatory compliance in biological product submissions, supporting transparency and scientific rigor in evaluation processes.
Public Consultation Period
The EDA invites stakeholders, including pharmaceutical companies, regulatory affairs professionals, and industry experts, to submit their comments and feedback.
Consultation period:
10 February 2026 to 24 February 2026
Feedback should be submitted via the Public Consultation Form to:
Biots.da@edaegypt.gov.eg
The draft guideline is available for review through this link:
Strategic Regulatory Context
This public consultation aligns with Egypt’s broader regulatory modernization efforts, reinforcing:
- Science-based evaluation of biological products
- Structured dossier requirements
- Greater stakeholder engagement in regulatory policymaking
- Strengthened oversight of innovative and biological medicines
By opening the draft for consultation, the EDA continues to promote transparency, regulatory efficiency, and industry collaboration in the development and lifecycle management of biological products.
Submit RFI/RFP