— Case Study —

Identifying New Acquisition Opportunities Through the UK International Recognition Procedure

Introduction

The UK International Recognition Procedure (IRP) offers pharmaceutical companies a faster route to UK market access by enabling reliance on approvals granted by recognised reference regulators. For organisations seeking to expand their portfolios through acquisition, identifying suitable marketing authorisations that align with IRP requirements can provide a significant strategic advantage. This case study demonstrates how our regulatory experts supported a pharmaceutical client in evaluating acquisition opportunities, assessing regulatory eligibility, and identifying marketing authorisations that could accelerate portfolio growth and UK market entry.

The Challenge

We were tasked with validating and identifying suitable market authorisations (MAs) to facilitate our client’s portfolio expansion.

This required leveraging our expertise in the UK’s new International Recognition Procedure (IRP) and conducting comprehensive analysis of existing national authorisations across multiple markets.

Our challenge was to evaluate available authorisations for specific dosage forms, product indications, or active pharmaceutical ingredients (APIs) to identify viable opportunities that aligned with our client’s growth objectives.

Our Comprehensive Approach

We began with a thorough clarification of our client’s specific needs, identifying target products and priority markets to establish clear parameters for our search.

Strategic Data Extraction: Our team conducted extensive research to extract relevant marketing authorisation data across multiple countries, focusing on opportunities that aligned with the client’s requirements.
IRP Compliance Assessment: We meticulously analysed all findings against UK International Recognition Procedure guidelines to develop a qualified list of viable marketing authorisations for potential acquisition.
Detailed Regulatory Review: Our experts performed comprehensive evaluations of country-specific requirements for the relevant active pharmaceutical ingredients and indications, identifying any regulatory nuances or obligations.
Strategic Insights Development: We compiled our findings into a comprehensive analysis, highlighting both potential challenges and strategic advantages for each opportunity.
Global Expertise Mobilisation: When required, we leveraged our regulanet® partnership network spanning over 90 countries to provide in-depth, market-specific insights and guidance.

Benefits

As a result of our targeted regulatory strategy, our client successfully identified viable marketing authorisations that met their specific portfolio requirements.

This comprehensive analysis enabled them to pursue acquisition discussions with confidence, securing key products that expanded their UK market presence. The detailed regulatory roadmap we provided streamlined their decision-making process, reduced their market entry timeline and delivered significant cost savings.

Conclusion

We delivered a comprehensive yet concise report analysing all relevant legislative and marketing authorisation data, demonstrating our commitment to being the #PartnerOfChoice to provide robust regulatory guidance that helps bring innovative medicines to UK patients while meeting our client’s specific business objectives.