Expert Guidance for Drug Product Registration in UK with MHRA
The United Kingdom represents one of the most advanced and opportunity-rich pharmaceutical markets in the world. However, pharmaceutical product registration in the UK requires precise understanding of the regulatory system governed by the Medicines and Healthcare products Regulatory Agency (MHRA).
At DDReg, we offer full-spectrum drug regulatory services in UK, helping sponsors and manufacturers navigate every stage of the pharmaceutical drug registration process from product classification and dossier preparation to submission and post-approval compliance.
MHRA Drug Registration for Global Companies
The MHRA (Medicines and Healthcare products Regulatory Agency) oversees all aspects of UK drug product registration, ensuring medicines meet high standards of safety, quality, and efficacy
Pharmaceutical companies seeking market authorisation in the UK must comply with the Human Medicines Regulations 2012 and follow MHRA’s guidance for submissions through the eCTD ( electronic Common Technical Document) format.
Types of Pharmaceutical Product Registration in the UK
1. National Procedure (UK-only Authorisation)
This applies when a company seeks approval to market a medicinal product exclusively in the UK.
- Timeline: 150–210 days (based on product type and completeness of dossier)
- Format: eCTD submission via MHRA Portal
- Outcome: UK Marketing Authorisation (MA)
2. International Recognition Procedure (IRP)
Introduced post-Brexit, this pathway allows MHRA to rely partly on assessments made by trusted authorities (e.g., EMA, FDA, Health Canada).
- Advantage: Faster market access and reduced duplication of review
- Use Case: Innovative or globally approved products
3. Accelerated and Innovative Licensing Pathways
MHRA offers fast-track and rolling review options for products addressing unmet medical needs, particularly in oncology, rare diseases, and advanced therapies.
Medicinal Product Classification in UK
Determining whether your product qualifies as a medicinal product is the first regulatory step.
According to MHRA, a medicinal product is one that:
- Has a pharmacological, immunological, or metabolic action
- Is presented as having medicinal properties
If your product lies at the borderline between medicine, medical device, or supplement, DDReg’s experts assist with medicinal product classification in the UK to define the right regulatory pathway.
Our MHRA Drug Registration Services
- Regulatory strategy and market entry planning for new drugs, generics, and biosimilars
- Product classification and regulatory pathway determination
- Dossier preparation and gap analysis (CTD/eCTD format)
- Pre-submission consultation and scientific advice with MHRA
- Local representation for non-UK sponsors
- Marketing authorisation submission and lifecycle management
- Compliance with GMP, pharmacovigilance, and post-marketing obligations
- Regulatory intelligence and continuous monitoring of MHRA updates
Why Choose DDReg for Pharmaceutical Drug Registration UK
- Regulatory Expertise: Deep understanding of MHRA’s procedures and updated post-Brexit requirements.
- Global Experience: Support for multinational companies seeking UK market authorisation.
- Full Lifecycle Management: From application to renewal, variations, and ongoing compliance.
- Strategic Advantage: Identification of accelerated or international recognition pathways to reduce time-to-market.
- Personalised Support: Dedicated drug registration consultant UK for every client.