• UAE: Regulatory Incentives and Logistics Strengthen Pharmaceutical Expansion Opportunities

    Positioning the UAE as a Regional Hub for Pharmaceutical Growth & Market Access Published June 13, 2026

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    EDE | Pharmaceuticals | Regulatory Affairs

  • Saudi Arabia: SFDA Explores Global Best Practices in Advanced Therapies During US Visit

    Strengthening Regulatory Readiness for Cell & Gene Therapies Published June 17, 2026

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    SFDA | Pharmaceuticals | Regulatory Affairs

  • China: ICH M11 Electronic Structured Clinical Protocol Guidelines Open for Public Consultation

    Advancing Clinical Trial Protocol Standardization & Global Regulatory Harmonization Comments Accepted Until July 12, 2026

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    NMPA | Pharmaceuticals | Regulatory Affairs

  • INVIMA ASS-RSA-IN56: Updated Guidelines for User Inserts, Prescribing Information (IPP), and Safety & Efficacy Modification Formats

    For preparing and harmonizing patient package inserts and prescribing information, and requirements/formats for submitting safety and efficacy modifications to the marketing authorization of medicines and biological products.

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    INVIMA | Pharmaceuticals | Regulatory Affairs

  • INVIMA ASS-RSA-FM080: Updated Evaluation Format for New Association, Pharmaceutical Form and Concentration of Synthetic Medicines

    Regulatory submission process for pharmaceutical products, including applicant information, product details, classification, and required studies.

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    INVIMA | Pharmaceuticals | Regulatory Affairs