Emerging markets, home to 85% of the world’s population, present major opportunities for pharma growth but bring complex regulatory, IP, and commercial challenges. Success requires strategies tailored to local realities: leveraging epidemiological data, navigating patent laws, and aligning with reimbursement rules that often mandate local manufacturing. Regulatory pathways are evolving, with reliance models, expedited reviews, and bridging studies helping speed access. Companies must also address GMP, supply chain localization, dossier formats, and post-approval obligations. A coordinated global-local regulatory strategy ensures compliance, faster approvals, and sustainable market entry.

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