Medicines and Healthcare Products Regulatory Agency
Regulatory Roundup: News & Publications in Pharma and Biotech in January 2026
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated […]
Comparing EU, UK and US Regulatory Approaches to Orphan Drugs
EMA, MHRA, and FDA: A Comparative Guide to Orphan Drug Regulations and how they affect medicine developers.
The UK’s Post-Brexit Orphan Drug Strategy
As of January 1, 2021, the UK established its own orphan drug process after leaving the European Union (EU). The Medicines and Healthcare Products Regulatory Agency (MHRA) now grants orphan designation at […]
Regulatory Roundup: News & Publications in Pharma and Biotech in November 2025
Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated […]
MHRA ILAP Relaunch 2025: Accelerating medicine approval in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated information on its Innovative Licensing and Access Pathway (ILAP) relaunch. The updates include new information on: Eligibility criteria, selection criteria and ILAP […]
What is the MHRA’s Innovative Licensing and Access Pathway (ILAP)?
The ILAP pathway is available to global commercial and non-commercial medicine developers. ILAP supports organisations developing new chemical substances and biologics, and new indications.
MHRA ILAP Relaunch 2025: Innovation Passport, Eligibility & Accelerated Access
The Innovative Licensing and Access Pathway (ILAP) is evolving to bring transformative medicines to NHS patients faster. Relaunching in March 2025, the updated pathway will feature streamlined processes, selective entry criteria, and […]
The MHRA’s International Recognition Procedure: Fast-track UK approval in 2–4 months
The MHRA's International Recognition Procedure (IRP) uses the approvals granted by other global regulatory agencies, offering a potential fast-track drug approval in the UK.