Secure Faster and Compliant Biological Product Approval in the EU
The European Union remains one of the most regulated, scientifically rigorous, and high-value biologics markets globally. Biologics Product Registration in the European Union requires alignment with EMA (European Medicines Agency) frameworks, scientific justification, quality validation, and lifecycle compliance. The EMA’s centralised procedure applies to biologics, biosimilars, gene therapies, cell-based therapies, and recombinant products, ensuring consistent safety, efficacy, immunogenicity, and GMP standards across EU-27 markets.
DDReg supports pharmaceutical and biotechnology companies with European Biologics Registration Services that streamline submissions, accelerate approvals, and strengthen regulatory confidence.
Biologics Registration Pathways in the EU
EU regulatory requirements depend on the type of biological product. Correct category classification determines dossier structure, clinical evidence, and approval strategy.
| Classification | Definition | Regulatory Pathway |
|---|---|---|
| New Biological Entity (NBE) | First-time biologic active substance not previously authorised in EU markets | Full development pathway via EMA centralised procedure |
| Biosimilar Product | A biological product demonstrating high similarity to a reference biologic authorised in the EU | Biosimilar comparability pathway under EMA biosimilar guidelines |
| Advanced Therapy Medicinal Product (ATMP) | Gene therapy, somatic cell therapy, or tissue-engineered construct | Regulated by the Committee for Advanced Therapies (CAT) |
The dossier format must comply with the Common Technical Document (CTD/eCTD), including Modules 1–5.
DDReg: Your European Biologics Regulatory Affairs Partner
DDReg provides Biologics Regulatory Services in the European Union with scientific rigor and submission excellence. Our team manages regulatory strategy, dossier creation, EU-specific technical compliance, and lifecycle maintenance.
Our focus aligns with EMA biologics guidance, EU GMP regulations, and local health authority expectations.
Our End-to-End Biological Product Registration Services
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Regulatory Strategy & Product Classification
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Dossier Compilation & eCTD Submission
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GMP, Manufacturing & Quality Compliance
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Biosimilar Development & Comparability Framework
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Lifecycle Management & Post-Approval Services
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Who Benefits from DDReg’s Expertise?