• Taiwan: Draft of ICH E19 – A Selective Approach to Safety Data Collection in Special Late-Stage Pre-Approval or Post-Approval Clinical Trials

    Enhancing Trial Efficiency While Safeguarding Patient Safety

    Released on November 3, 2025 | Public review open for 60 days

    Consult NowKnow More
    TFDA | Pharmaceuticals | Regulatory Affairs

  • China: ICH Q9(R1) Annex 1 – Q8, Q9 & Q10 Questions & Answers (R5)

    Aligning Quality by Design, Risk Management & PQS Practices

    Effective from October 31, 2025 | Public consultation open until November 30, 2025

    Consult NowKnow More
    NMPA | Pharmaceuticals | Regulatory Affairs

  • China: Annex Methodological Guidelines for Pharmacoepidemiological Research (2nd Edition)

    Enhancing Real-World Evidence & Safety Research Standards

    Effective from November 3, 2025

    Consult NowKnow More
    NMPA | Pharmaceuticals | Regulatory Affairs

  • MFDS South Korea Launches Electronic Test and Inspection Certificate System for Food and Drug Sectors

    Experience Faster, Paperless Test Report Issuance — Anytime, Anywhere via Government24!

    The regulation was released on November 4, 2025

    Consult NowKnow More
    MFDS | Pharmaceuticals | Regulatory Affairs

  • COFEPRIS Publishes Technical Guide for the Recognition of Orphan Medicines (CTD-based)

    The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has published a technical guide that standardizes the submission of applications for the recognition of orphan medicines and their subsequent variations, in alignment with the Common Technical Document (CTD) format.

    The guide is now effective

    Consult NowKnow More
    COFEPRIS | Pharmaceuticals | Country Regulatory Affairs