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作者: rick

New Beginnings, New Horizons: A Strategic Merger for Enhanced Pharmaceutical Solutions

Hangzhou, February 12, 2025 – REACH24H BaiPha […]

Pathway Options for China Drug Master File (DMF) Registration:An Analysis of the Strategic Options

This is the second article in a series focusing on Chin […]

China Drug Master File (DMF) Registration: A Snapshot on Pathways and Requirements

This is the first article in a series focusing on China […]

China’s DMF API License Renewal: Understanding NMPA’s Policy Update

Announcement No. 129 of 2023 was released by the Nation […]

China Drug Master File (DMF): Excipients Exemption List

Did you know that certain pharmaceutical excipients are […]

CHINA CDE EYES MORE DRUG APPROVALS BY 2025

China CDE director vows more support for drug review &a […]

DMF IN CHINA NEW POLICY ON ACTIVE PHARMACEUTICAL INGREDIENTS (API) RENEWAL

NMPA News: China’s National Medical Products Administra […]

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Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients. and Packaging Materials (2020 Draft for Comments)

    * To download, please fill-out your information below and the regulation in PDF file will be sent directly to your email address directly.

    Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review & Approval and Supervision (2019 No.56)

      To download, please fill-out your information below and the regulation in PDF file will be sent directly to your email address directly.

      Announcement for Adjusting Evaluation and Approval for APls, Excipients and Packaging Materials (2017 No.146)

        * To download, please fill-out your information below and the regulation in PDF file will be sent directly to your email address directly.

        Provisions for Drug Registration (2020 No.27)

          * To download, please fill-out your information below and the regulation in PDF file will be sent directly to your email address directly.