Module 1 2021

25/06/2021

Requirements for local registration studies

CHINA: Most common registration route is global trial registration route • Phase I PK data in Chinese pts. • Phase III data if China is participating in Global Clinical Trial, usually 10-20% of total global size.

JAPAN: PK evaluation in Japanese population is mandatory for J-NDA submission; PMDA accepts global/Asian phase II and Phase III data including Japanese patients for J-NDA.

KOREA: Require local bridging data to global clinical data package, per ICH E5 • PK/PD, dose-response, or safety/efficacy assessment in Korean patients compared with global data. No specific numbers of patient numbers mentioned in regulations.

TAIWAN : Require ‘bridging data’ to global clinical data package, per ICH E5 • No minimum patient numbers mentioned regulations. Flexible in accepting Asian, non-local Phase III data • Incentives in terms of speed, help with study and reimbursement outcome INDIA : Local study with pivotal design . Mandatory to have local data from bridging study or Phase III CT study on Indian patient population for new drug. If data not available (exceptional cases), strong justification for waiver of trial. In case where DCGI approves without CT - Phase IV study required. More clarification added in the new draft Clinical Trial Regulation which is under finalization process currently. RUSSIA : For new products R ussian patients are required in a global phase III or local trial. For generics a local BE study is required.

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Bridging Study

A study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region. (ICH E5 1998 “Ethnic Factors in the Acceptability of Foreign Clinical Data”)

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