The growth potential for biopharmaceutical companies in emerging markets is no secret. By 2015, up to 35% of the global biopharmaceutical market will be in China and other developing countries. Yet even though most companies have reset their research and development (R&D) and supply chain models to support global expansion, their regulatory submission strategies and capabilities often fall short. The number of regulatory requirements has grown exponentially as biopharmaceutical companies enter new and disparate markets, but efforts in global regulatory harmonization have stalled. To support the global growth imperative, regulatory functions must meet the local needs of a greater number of countries while supporting an expanding list of products and aggressive project timelines. Altering regulatory strategies to meet new business models will generate faster approvals and help propel growth in emerging markets.

Biopharmaceutical companies have honed their regulatory submission operating models to facilitate introduction of new products in the United States, Europe, and Japan. But those models are not always transferrable to emerging markets. Only by taking a comprehensive approach to strategy, capabilities, and processes can companies hope to achieve near-simultaneous global approvals.

DEFINE A GLOBAL REGULATORY STRATEGY

An effective global regulatory strategy must address both the differences and the similarities across markets. Companies should maximize common elements of the global dossier while ensuring that each submission for market authorization can be tailored to meet local regulatory requirements. Standards of care, clinical trial requirements, distribution needs, and local regulations vary greatly across countries and regions.

Here’s one example of country differences: Emerging countries often make product approval contingent upon regulatory approval in a reference country, where the product undergoes a more advanced and rigorous health authority review. To minimize approval delays in emerging countries, biopharmaceutical companies can “prime the pump” by generating the emerging-market filing in parallel with the primary filing and completing prereviews with those health authorities so that the filing can be submitted as soon as approval has been granted in that reference country. Companies’ global regulatory strategies should outline the type and sequence of such submissions, taking into account the unique requirements of each country involved in a development plan.

BUILD GLOBAL CAPABILITIES

Local presence and expertise are critical for global success. Companies must not only evolve their commercial, R&D, and supply chain organizations to meet the needs of the global marketplace, but they also must adapt their regulatory organizations. It is important to rethink how governance bodies are structured. It’s no less important for companies to focus on optimizing their global footprint with internal resources and strategic partners. The challenge is to develop a sourcing and organizational model that builds global capabilities without increasing cost and infrastructure. Collaboration among global and local resources, both within a company and involving its strategic partners, is essential for delivering products that meet the needs of local markets.

DEVELOP GLOBAL REGULATORY PROCESSES

On average, it takes leading biopharmaceutical companies six to 12 months to execute submissions in emerging markets. World-class processes can cut that time in half. The expanded role of regulatory requirements mandates a rigorous set of processes to ensure that local execution occurs within the construct of a global organization and in support of its global strategy. Biopharmaceutical companies must clarify roles and responsibilities for development, submission, and approval processes, as well as for management throughout the life cycle of each global dossier. They also need an issue escalation process that clearly identifies responsibilities of the global team while empowering local teams to take action. For example, consider responses to health-authority questions. They often require local expertise and speed but must also be made within the context of a global development program and in alignment with a company’s global regulatory strategy.

For biopharmaceutical companies that are keen on accelerating global expansion, “Think global, act local” is more than just a bumper sticker slogan. By redefining their regulatory operating models now, such companies will be better positioned to achieve near-simultaneous global market approvals and reach populations in need of their products, wherever those patients may be.

About the Author

Author Details
Rob Franco, PhD ([email protected]) and Vitaly Glozman ([email protected]) are partners, Carl Finamore ([email protected]) is a principal, and Amanda Boyle ([email protected]) is a manager, all in the healthcare practice at global management consulting firm PRTM, 77 Fourth Avenue, Waltham, MA 02451; 1-781-434-1200, fax 1-781-647-2804; www.prtm.com.