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NMPA Released Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
    Pubtime: 2021-10-29

  On November 12, 2019, NMPA issued the Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions, which reads as follows:

  To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply 15 ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines, including the E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life- Threatening Conditions (see annex for details). The relevant matters are announced as follows:

  I. E2F: Development Safety Update Report and E2F Examples, E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data and E5 Q & A (R1), and E17: General Principles for Planning and Design of Multiregional Clinical Trials shall be applied as from the date of issuance of this Announcement.

  2. For new drug marketing applications accepted 6 months after the date of this Announcement, E3: Structure and Content of Clinical Study Reports and E3 Q & A (R1) are applicable.

  3. E2E: Pharmacovigilance Planning is applicable to new drug marketing applications accepted after 3 months from the date of this Announcement, and new drug marketing applications approved after 6 months from the date of this Announcement.

  4. The relevant requirements for drug clinical research started 6 months after the issuance date of this Announcement shall apply the E4: Dose-Response Information to Support Drug Registration, E7: Studies in Support of Special Populations: Geriatrics and E7 Q & A, E8: General Considerations for Clinical Trials, E9: Statistical Principles for Clinical Trials, E10: Choice of Control Group and Related Issues in Clinical Trials, E11 (R1): Clinical Investigation of Medicinal Products in the Pediatric Population, E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding, and E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.

  5. Clinical trial applications approved 6 months after the date of issuance of this Announcement and new drug marketing applications accepted 3 years later shall apply to E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions.

  6. E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs shall be applied to clinical trials for new antihypertensive drugs 6 months after the date of issuance of this Announcement, where the sample size of subjects required for safety assessment shall be based on the requirements of E1 schedule.

  Relevant technical guidelines can be found on the website of Center for Drug Evaluation NMPA, who is responsible for related technical guidance in the implementation of this Announcement.

  Attachment (omitted)

  (November 12, 2019)

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