Top news
International Cooperation

search

topic
content
International Organization Programs
Announcement of NMPA on Applying 11 ICH Guidelines Including Q2 (R1): Validation of Analytical Procedures: Text and Methodology
    Pubtime: 2021-10-29

  On January 21, 2020, NMPA issued the Announcement of NMPA on Applying 11 ICH Guidelines Including Q2 (R1): Validation of Analytical Procedures: Text and Methodology, which reads as follows:

  To keep pace with the international technical standards for drug registration, NMPA has decided to apply 11 ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, including the Q2(R1): Validation of Analytical Procedures: Text and Methodology. The relevant matters are hereby announced as follows.

  1. Applicants must conduct research in accordance with the ICH guidelines ASAP based on the current technical requirements for pharmaceutical research; pharmaceutical research that begins 6 months after the issuance date of this Announcement (based on the time point of the trial record) shall apply the ICH guidelines.

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

  (January 22, 2020)

Produced By CMS 网站群内容管理系统 publishdate:2023/11/07 08:53:02