ICH E17-GL is an international guideline on how to design multi-regional clinical trials (MRCTs) — studies that enroll patients from different regions in one gl...
What is Japanese Clinical Data Comparability?
Japanese clinical data comparability refers to the process of showing that the safety and effectiveness of a drug — proven in non-Japanese patients (often Cauca...
Japanese Clinical Data: Proving Comparability with Caucasian Populations
This blog talks about the necessity of Japanese clinical data to demonstrate comparability with Caucasian populations, guiding global regulatory strategies.
Top 12 Frequently Asked Questions About Drug Regulatory Affairs in China
This blog talks about answers to the top 12 FAQs on drug regulatory affairs in China (2025 update), guiding compliance, approvals, and NMPA strategies.
How Will NMPA’s 2025 eCTD Update Impact Your Product Launch Timeline?
This blog talks about how the NMPA’s 2025 eCTD update will affect your product launch timeline, highlighting streamlined processes, consistency, and enhanced li...
Query Handling & Life Cycle Management (LCM) Support in Australia
This blog talks about how Freyr’s regulatory experts in Australia ensure seamless TGA query handling and life-cycle management support to be compliant.
ICH E17-GL: General Principles for Planning and Design of Multi-Regional Cl...
This blog talks about the ICH E17-GL guideline’s harmonized framework for planning and designing multi-regional clinical trials to foster global drug approval.
