NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles

China's National Medical Products Administration (NMPA) has published an announcement regarding the application of the principle of the ICH Q2(R2) Guideline on validation of analytical procedures and Q14 Guideline on analytical procedure development.

According to the announcement, applicants are required to conduct studies in accordance with the requirements of the ICH Q2(R2)/Q14 Guidelines. The Q2(R2)/Q14 Guidelines are applicable to the relevant studies starting from 24 November 24 (based on the time point of the trial record).

The statement further says that ICH Q14 provides two development approaches, and applicants may choose either the traditional approach or the enhanced approach, or they may choose to partially adopt the enhanced approach.

Applicants submitting registration applications that also address ICH Q12 should also implement the requirements of the applicable Q12 standards.

The information was published in Chinese language on 28 May 2024 on the NMPA website.