GCC centralized registration

GCC 2026 Regulatory Trends Shaping Pharma and Biotech

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GCC pharma regulations in 2026 emphasize eCTD v4.0 adoption, harmonization, real-world evidence, and strict Saudi/UAE rules. Strategic compliance and local QPPV roles are key for market access.

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Emerging Trends Shaping Pharmaceutical Regulations in the GCC and Middle East

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GCC pharmaceutical regulations are evolving with centralized registration, stricter Saudi SFDA/UAE MoHAP policies, enhanced pharmacovigilance, digital submissions, and growing use of real-world evidence.

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