• The Department is a part of the Registration department in the Central Administration for Pharmaceutical Affairs in the Ministry of Health.
• The Department is responsible for Registration of Biological products including (Vaccines,Blood and Biotechnology products).
• Internal Organogram:
There are four sections in the Biological products registration department as follows:
- Reception & Hard file
- Specialized Scientific committee for vaccines & sera and Preliminary evaluation for biological products and blood products.
- Technical committee
To be the leading regional regulatory authority for biological products with professional and excellent services and distinctive speed and accuracy that contributes to the protection and advancement of the health in Egypt.
Taking the poor quality and counterfeit biological products that are unsafe may lead to a treatment failure or death in some cases. Also, it bring the lack of trust felling by consumers toward the health regulations, people who works in the medicinal field, manufacturer of biological products and their distributors. So, establishing a national authority specialized in organizing the biological products industry to protect the public health was very essential.
To ensure the safety, efficacy and quality of biological products; by developing and enforcing an appropriate regulatory system.
- communicating and coordinating with Biological products companies regards missing requirements in registry file and procedures of biological products registration.
- Build an affective relationship with the international authorities and scientific societies.
- Preparing and updating of regulations on registration of biological products.
- Receiving and reviewing the requirements of new products registration and variant applications.
- Assessing the safety, efficacy and quality of medications, and issuing marketing authorization.
- Supervising the archiving of biological products files.
- Revising scientific dossier &clinical studies and issuance of approval Through Specialized Scientific committee for vaccines & sera and Preliminary evaluation for biological products and blood products
-Evaluating Variations submitted for different biological products and issuing approvals.
- Finally, Following, developing and receiving inquires and suggestions.
What is a biological medicinal product?
A biological medicinal product is a product derived from living organisms ranging from normal or genetically modified microorganisms to fluids & tissues derived from various animal & human sources
Types of biological medicinal products:
- Immunological medicinal products:
Any medicinal product consisting of vaccines, toxins, serums or allergen products:
(a) Vaccines, toxins and serums including:
(b) Allergen product: any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
- Agents used to produce active immunity
- Agents used to produce passive immunity
- Medicinal products derived from human blood and human plasma
- Medicinal products developed by means of one of the following biotechnological processes:
- Recombinant DNA technology
- Controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells
- Hybridoma and monoclonal antibody methods
- Other miscellaneous group of products:
Produced by or extracted from biological origin (except plants) including, for example, hormones, and larger peptides---etc.
All the above categories are common in that they are more difficult to characterize or control than chemically synthesized pharmaceuticals due to their complex molecular structure.
E-mail : Scientific and Technical departments: email@example.com
Reception department: firstname.lastname@example.org
Variation Department: email@example.com
Phone No. : +2 – (02) 23684288 / +2 – (02) 23648769 / +2 – (02) 23684194
Ext. : 1208 / 1330
Fax No. : +2 - (02) 23684194
Minister Decrees: Minister Decrees NO. 820/2016: Ministrial Decree No.297/2009 :Registration of Biologicals Arabic version Ministrial Decree No.297/2009 :Registration of Biologicals English version Ministrial Decree No.250/2015 :update for item No.(7) in Ministrial Decree No.297/2009 Ministrial Decree No.150/2015 : Approval on Application of Guidelines for Registration of Biosimilar products in Egypt
Fast Track Guidelines
Guidance for variations in biological medicinal products
Guidelines for registration of Second Brand products
Guidelines for Registration of Biosimilar products in Egypt.
Guidelines for categorization of type of Application as new product or variation for parenteral biological preparations
Workflow for variations department of biological products directorate.(last update 18/11/2018)
Work flow for Registration of biological products.(last update 18/11/2018)
Workflow for Technical department of biological products directorate.(last update 18/11/2018)
List Of All Registered Biological Products:
List of registered vaccines in Egypt (last updated 18/11/2018)
The update registered biological product since 2009 (last updated 18/11/2018).
- Applications: (last update 18/11/2018)
- Checklists: (last update 18/11/2018)
Check List for Registration of biological medicinal products Check List for Re-registration of biological medicinal products
Scientific file requirements for an Exemption File. Requirements for receiving biological products inserts (pharmacology) Checklist for Receiving Plasma Master File
General technical Regulatory Decisions sheet for Biological Products. (last updated 18/11/2018)