Biologics Product Registration in UK

Entering the UK biopharmaceutical market requires a comprehensive understanding of the Medicines and Healthcare products Regulatory Agency (MHRA) and its evolving post-Brexit framework. At DDReg, we provide end-to-end UK biologics registration services, from classification and strategy development to dossier preparation, submission, and lifecycle management.

Our expertise ensures compliance with MHRA regulations for both new biological entities (NBEs) and biosimilar products, helping your biologics reach the UK market faster and more efficiently.

The MHRA regulates the approval of all biological medicinal products in the UK. These include vaccines, monoclonal antibodies, recombinant proteins, and biosimilars.

• New Biological Entities (NBEs): Innovative biologics containing a new active substance not previously authorised in the UK.
• Biological Products (Biosimilars): Follow-on versions of previously approved biologics that demonstrate comparable safety, efficacy, and quality.

Biologics in the UK are authorised under the Human Medicines Regulations (HMR) 2012, which outline procedures for national, UK-wide, and international recognition pathways.

• + UK-Wide Marketing Authorisation (MA)
  • Issued by MHRA and valid across Great Britain and Northern Ireland.
  • Required for all biologics and biosimilars seeking market entry in the UK.
• + New Biological Entity Registration (NBE Registration UK)
  • Full dossier (CTD Modules 1–5) submission required.
  • Clinical and non-clinical data must demonstrate safety, efficacy, and quality.
  • Access to MHRA’s International Recognition Procedure (IRP) for streamlined approvals.
• + Biosimilar Product Registration
  • Follows MHRA’s biosimilar guidelines under Regulation 53B.
  • Requires detailed comparability data (analytical, non-clinical, and clinical).
  • Reference Medicinal Product (RMP) must be authorised in the UK for at least 8 years.
• + Advanced Therapy Medicinal Products ( ATMPs)
  • For biologics classified as cell or gene therapies, the MHRA provides dedicated ATMP regulatory guidance with unique review procedures.

• + Regulatory Strategy & Product Classification
  • Determination of product type (NBE or Biosimilar)
  • Regulatory roadmap and pathway selection (National / IRP)
  • Early consultation with MHRA for risk mitigation
• + Dossier Preparation & Submission (CTD/eCTD)
  • Preparation of quality, non-clinical, and clinical modules
  • Technical document harmonisation and UK adaptation
  • eCTD formatting and submission via MHRA Portal
• + GMP and Manufacturing Compliance
  • GMP audit readiness and documentation review
  • Coordination for manufacturing site inspections
  • Compliance verification with MHRA standards
• + Biosimilar Development & Comparability Support
  • Analytical comparability study support
  • Bridging data strategy for non-UK reference products
  • Clinical data evaluation and justification preparation
• + Post-Approval Lifecycle Management
  • Post-marketing variations (Type IA/IB/II)
  • Renewals, safety updates, and pharmacovigilance setup
  • Labelling, packaging, and safety data maintenance
• + Local Regulatory Representation
  • MHRA liaison and submission management
  • Document legalization and translation
  • Ongoing authority communication support

• End-to-End Expertise: From clinical development to market access
• MHRA-Aligned Compliance: Adherence to the latest MHRA and HMR guidelines
• Regulatory Intelligence: Insights into UK-specific updates, timelines, and best practices
• Proven Experience: Over 16 years supporting global biologics and biosimilars registrations
• Integrated Support: Combined regulatory, CMC, and pharmacovigilance expertise