In an ever-evolving world of biopharmaceuticals, mergers, acquisitions, divestments and spin-offs are crucial for growth strategies. These activities often result in the transfer of authorized medical products to new companies—or other legal entities within the same company—thus transferring the marketing rights to the transferee in a particular country, region, or globally. While Marketing Authorization Transfer (MAT) is typically an administrative procedure, it has proven to involve complex activities and numerous steps that demand insightful planning and precise execution from the regulatory, quality, pharmacovigilance, commercial and supply chain teams.

New companies often seek to expand their global footprint or strengthen a therapeutic area, by acquiring new portfolios and drugs under developmental stages. However, after finalizing the deal, they often find that they do not have the required internal expertise and resources to meet legal obligations across different regions, ensuring the successful transfer of the marketing authorization holder.

MAT complexities are unique to each deal and require consideration of several factors, including the type and number of assets, the readiness and footprint of the acquiring company, the countries involved, supply chain factors, and commercial priorities. The regulatory status, ongoing and planned procedures and compliance requirements in each market also shape the MAT process and often affect other functions’ decisions. In other words, regulatory compliance is a critical factor for overall transition success.

Technical challenges, such as data transfer issues, may arise, requiring extra steps for a smooth transition. Each transfer of marketing authorization holder needs a custom approach, tailored to the deal's complexities and requirements, demanding regulatory knowledge, technical skills, and strategic planning. Many clients rely on experienced regulatory service providers for due diligence, strategic planning, regulatory intelligence, regulatory project management and end-to-end execution. These regulatory vendors are invaluable partners in ensuring a smooth transfer, especially in today's dynamic biopharmaceutical landscape where efficiency, risk management and regulatory compliance are crucial.

Key considerations for effective Marketing Authorization Transfers

Biopharma mergers and acquisitions (M&A) and asset transfer negotiations often overlook the importance of regulatory expertise and early involvement, leaving decision-makers unprepared for the challenges associated with asset transfers. The following table outlines key considerations for ensuring an effective MAT process:

What does a successful MAT strategy look like?

Accurate estimation and planning: A successful MAT strategy begins with precise estimation of timelines, costs, and workload, in alignment with the agreed transitional milestones. This ensures that all aspects of the transfer are well-planned, and resources are allocated efficiently.

Early regulatory strategy: Implementing a regulatory strategy during the due diligence phase is crucial. Early involvement of regulatory experts helps identify potential challenges and develop effective solutions ahead of time.

Comprehensive regulatory intelligence: Exhaustive regulatory intelligence is essential for preparing detailed transfer plans. This includes understanding local regulatory requirements—frequently not stated in regulations—and aligning with local representatives or partners to ensure regulatory compliance.

High-quality deliverables: Ensuring high-quality deliverables is key to achieving first-time-right submissions. This includes accurate documentation and timely submissions to regulatory authorities, which helps in maintaining product availability and meeting market demands.

Cross-functional alignment: Effective cross-functional alignment with relevant groups, including sales, supply chain, regulatory and pharmacovigilance, is vital. This coordination helps manage product transition during supply constraints or high demands, ongoing procedures, and contractual obligations, while maintaining compliance with regulatory requirements and grace periods.

Why choose IQVIA’s MAT regulatory experts?

Proven track record: IQVIA has successfully managed over 50 deals, demonstrating its expertise and reliability in handling complex Market Authorization Transfers (MAT) for both registered products and compounds under development, in all therapeutic areas.

Extensive experience: With more than 11,000 successful licenses transferred, IQVIA’s team has the experience needed to navigate regulatory landscapes effectively with in-depth understanding of cross-functional implications.

Global reach: IQVIA can support you in all regions globally, including Europe, North America, LATAM, CIS, APAC, Central America and the Caribbean, MENA, and Africa. This extensive coverage ensures the team can manage transfers in diverse regulatory environments, leveraging our low-cost regulatory hubs to manage all executional tasks.

Comprehensive support: IQVIA provides end-to-end support, from early regulatory strategies during the due diligence phase to high-quality deliverables for submission and complete project oversight, tracking and coordination.

AI-powered regulatory intelligence: Leveraging AI-powered regulatory intelligence, IQVIA provides strategic insights into Market Authorization Transfers (MAT) for over 100 markets. This regulatory intelligence, drawn from our extensive partnership experience and AI-automated insights, is also shared with our clients, ensuring they retain valuable knowledge accumulated during the project and strengthening their strategic decision-making capabilities.