Approve

Divergent regulatory requirements across markets, such as different data packages, local testing expectations, and dossier formats, create redundant work that delays patient access to new medicines. Our approach addresses this challenge across four complementary dimensions:

• building the operational infrastructure that makes simultaneous submissions in many countries possible at scale,

• compressing submission timelines where possible,

• leveraging unique regulatory pathways to bring medicines to patients in more low- and middle-income countries, and

• advocating for regulatory harmonization.

These elements work together. Building and scaling this infrastructure enables broader submissions, and harmonized requirements reduce the duplication that slows approvals across markets.

The Infrastructure Behind Simultaneous Submissions

Submitting a medicine for approval in multiple countries simultaneously rather than sequentially over months or years requires purpose-built infrastructure. We have invested in capabilities that shift regulatory work earlier in the development cycle and enable parallel execution across markets: centralized content planning that allows submission packages to be built once and deployed across dozens of countries; AI-based translation that has cut document preparation time from months to minutes; dedicated response teams that manage simultaneous questions from multiple health authorities in parallel rather than one at a time; and digital tools that provide real-time visibility across global submissions. These capabilities enable us to pursue simultaneous filings in more than 40 countries, with the goal of compressing the time between first submission and broad global availability.

Reaching Patients in New Markets Faster

While our simultaneous submission strategy primarily addresses speed to submission in developed markets, an equally important dimension of our regulatory approach is expanding into markets where patients currently have no access to our medicines. We currently sell medicines in approximately 90 countries. We are evaluating mechanisms to extend our reach beyond that footprint — particularly into low- and middle-income countries (LMICs) where regulatory infrastructure may be less developed and where the burden of non-communicable diseases is often greatest.

Key elements of this strategy include leveraging WHO Prequalification and reliance-based pathways for efficient LMIC approvals, pursuing strategic entry into markets where we are not yet present, and working with regional regulatory authorities to build capacity and reduce barriers to access. Regulatory approval of a new medicine in many LMICs often occurs years after approval in developed markets, with some medicines never becoming available. By seeking to extend our regulatory reach beyond our traditional markets, we aim to ensure that the people who carry the burden of disease have the opportunity to benefit from the same innovations available in higher-income countries.

Harmonizing Standards Across Markets

Beyond our own submissions, we advocate for ways to close the approval gap between the U.S. and EU and the rest of the world. We invest in advancing regulatory convergence — working with health authorities, industry organizations, and multilateral bodies to promote the common standards and pathways that allow regulators to build on each other’s assessments. When regulatory authorities can leverage assessments from other agencies, it reduces duplicative review cycles and accelerates the path to approval in multiple markets simultaneously. This work benefits not only approvals of our own medicines but the broader pharmaceutical ecosystem.

Our regulatory convergence efforts span multiple regions. We engage with regulatory bodies across Latin America, Asia-Pacific, the Middle East, and Africa on topics including adoption of guidelines developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) — the global body that establishes common standards for pharmaceutical development and registration — as well as reliance-based review models and streamlined data requirements. In each case, the objective is the same: to create more predictable and efficient pathways so that patients in more countries can access new medicines without unnecessary delay.

In 2025 and early 2026, our simultaneous submission approach produced results across both priority launches and the broader portfolio. For example, in 2025, we submitted orforglipron (now approved in the U.S. as Foundayo), an oral GLP-1 medicine for weight management, for regulatory approval in more than 40 countries within three months of first submission.

We intend to continue pursuing simultaneous submissions for new molecular entities and major new indications, maintaining momentum in markets where we currently operate and expanding into markets where we have had limited or no presence historically. We expect to continue scaling the infrastructure that enables parallel submissions, with the goal of further reducing cycle times. On regulatory convergence, we plan to continue engaging with health authorities across regions to advance common standards and review pathways that benefit the broader field.

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