NMPA announces adoption of 15 ICH efficacy guidelines (NMPA Announcement No. 88 )
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 15 ICH efficacy guidelines, including E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions (see the attachment for further information).
Items of the Announcement are as follows.
I. The guidelines below shall be adopted from the issue date of this Announcement:
E2F: Development Safety Update Report and E2F: Example DSUR – Phase III Investigational Drug;
E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data and E5 Q&A (R1); and
E17: General Principle on Planning and Designing Multi-Regional Clinical Trials.
II. New Drug Applications (NDAs) accepted six months and beyond after the issue date of this Announcement shall adopt E3: Structure and Content of Clinical Study Reports and E3 Q&A (R1).
III. NDAs accepted three months and beyond and NDAs approved six months and beyond after the issue date of this Announcement shall adopt E2E: Pharmacovigilance Planning.
IV. Clinical studies of drugs initiated six months and beyond after the issue date of this Announcement shall adopt the following guidelines:
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): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population;
E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories; and
E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions.
V. Investigational New Drugs (INDs) approved six months and beyond and NDAs accepted three years after the issue date of this Announcement shall adopt E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions.
VI. Clinical studies of new anti-hypertensive drugs six months and beyond after the issue date of this Announcement shall adopt E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs.
The relevant efficacy guidelines are available on the official website of the Center for Drug Evaluation of NMPA. The Center for Drug Evaluation of NMPA is responsible for technical guidance in the implementation of the Announcement.
Attachment：15 ICH safety guidelines to be adopted
National Medical Products Administration
November 5, 2019